Postmenopausal Women With OsteoporosisPhase 3ARCHNCT01631214
Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis
A Phase 3 study testing Romosozumab and Alendronate in people with Postmenopausal Women With Osteoporosis, run by Amgen at 316 sites in 42 countries.
Trial summary
The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis. Read more about this study
- Who is it for?
- Ages 55 to 90 years, women only
- Conditions the study is for
- Postmenopausal Women With Osteoporosis
- What is being tested?
- Romosozumab and Alendronate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4,093 participants
- Where
- 316 sitesin 42 countries
- Study dates
- 4 May 2012to 29 Jun 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women who meet at least one of the following bone mineral density (BMD) and fracture criteria:
- BMD T-score at the total hip or femoral neck of ≤ -2.50 and EITHER:
- at least 1 moderate (semiquantitative grade [SQ]2) or severe (SQ3) vertebral fracture OR
- at least 2 mild (SQ1) vertebral fractures OR
- BMD T-score at the total hip or femoral neck of ≤ -2.00 and EITHER:
- at least 2 moderate (SQ2) or severe (SQ3) vertebral fractures OR
- a fracture of the proximal femur that occurred within 3 to 24 months prior to randomization.
Who cannot join
- History of metabolic or bone disease (except osteoporosis)
- Use of agents affecting bone metabolism
- Vitamin D insufficiency
- History of solid organ or bone marrow transplants
- Hyper- or hypocalcemia
- Hyper- or hypothyroidism
- Hyper- or hypoparathyroidism
- Possible signs of intolerance to alendronate
Trial locations and contacts
316 sites in 42 countries.
316 sites in 42 countries
United States32 sites
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Bethesda, Maryland, 20817
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Birmingham, Alabama, 35294
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Bismarck, North Dakota, 58503
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Boston, Massachusetts, 02114
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Detroit, Michigan, 48236
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Downey, California, 90242
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Fort Lauderdale, Florida, 33309
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Gainesville, Georgia, 30501
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Great Neck, New York, 11021
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Greenbrae, California, 94904
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Indianapolis, Indiana, 46202
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Lakewood, Colorado, 80227
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Las Cruces, New Mexico, 88011
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Las Vegas, Nevada, 89148
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Los Angeles, California, 90057
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Madison, Wisconsin, 53705
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Maywood, Illinois, 60153
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Miami, Florida, 33136
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Peoria, Arizona, 85381
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Phoenix, Arizona, 85037
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Pittsburgh, Pennsylvania, 15213
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Port Angeles, Washington, 98362
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Quincy, Illinois, 62301
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Richmond, Virginia, 23233
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Scottsdale, Arizona, 85258
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South Lake Tahoe, California, 96150
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St Louis, Missouri, 63110
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Stuart, Florida, 34996
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Tustin, California, 92780
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Walnut Creek, California, 94598
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West Palm Beach, Florida, 33409
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Wyomissing, Pennsylvania, 19610
Poland22 sites
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Bialystok, 15-351
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Bialystok, 15-879
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Dabrowka Dopiewo, 62-069
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Elblag, 82-300
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Gdynia, 81-384
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Gliwice, 44-100
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Katowice, 40-040
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Kielce, 25-317
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Krakow, 30-510
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Krakow, 31-501
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Lodz, 09-245
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Lodz, 90-558
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Poznan, 60-356
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Poznan, 60-702
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Świdnik, 21-040
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Torun, 87-100
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Warsaw, 01-192
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Warsaw, 02-507
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Warsaw, 04-730
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Wroclaw, 50-088
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Wroclaw, 51-124
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Wroclaw, 53-224
Germany15 sites
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Berlin, 12200
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Bonn, 53105
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Dresden, 01307
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Frankfurt am Main, 60528
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Frankfurt am Main, 60596
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Freiburg im Breisgau, 79106
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Hamburg, 20354
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Hanover, 30167
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Heinsberg, 52525
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Hellersdorf, 12627
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Leipzig, 04103
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Magdeburg, 39104
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Marburg, 35043
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München, 80336
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Würzburg, 97074
United Kingdom15 sites
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Birmingham, B15 2SQ
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Cambridge, CB2 0QQ
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Cardiff, CF14 5GJ
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Chorley, PR7 7NA
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Edinburgh, EH4 2XU
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Glasgow, G20 0SP
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Liverpool, L22 0LG
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Manchester, M15 6SX
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Northwood, HA6 2RN
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Norwich, NR4 7TJ
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Reading, RG2 0FT
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Sheffield, S5 7AU
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Sidcup, DA14 6LT
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Staffordshire, WS11 5XY
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Warwick, CV34 5BW
Russia13 sites
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Arkhangelsk, 163001
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Ivanovo, 153025
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Moscow, 101990
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Moscow, 115522
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Moscow, 117036
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Moscow, 127299
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Nizhny Novgorod, 603155
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Petrozavodsk, 185019
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Saint Petersburg, 190103
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Saint Petersburg, 194291
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Saint Petersburg, 199034
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Yaroslavl, 150003
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Yekaterinburg, 620102
Canada12 sites
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Halifax, Nova Scotia, B3H 2Y9
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Kitchener, Ontario, N2M 1A1
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Montreal, Quebec, H3T 1E2
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Montreal, Quebec, H4A 3J1
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Québec, Quebec, G1V 3M7
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St. John's, Newfoundland and Labrador, A1B 3V6
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Toronto, Ontario, M5C 2T2
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Toronto, Ontario, M5G 2C4
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Trois-Rivières, Quebec, G8Z 1Y2
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Vancouver, British Columbia, V5Z 4E1
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Westmout, Quebec, H3Z 1E5
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Winnipeg, Manitoba, R3A 1M3
Hungary12 sites
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Balatonfüred, 8230
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Békéscsaba, 5600
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Budapest, 1036
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Budapest, 1083
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Budapest, 1084
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Debrecen, 4032
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Győr, 9023
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Kaposvár, 7400
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Kiskunhalas, 6400
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Kistarcsa, 2143
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Veszprém, 8200
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Zalaegerszeg, 8900
Italy12 sites
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Arenzano GE, 16011
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Bologna, 40138
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Catania, 95124
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Florence, 50139
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Milan, 20145
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Pisa, 56124
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Pisa, 56126
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Roma, 00161
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Siena, 53100
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Torino, 10126
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Verona, 37126
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Verona, 37134
Czechia11 sites
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Brno, 602 00
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Hradec Králové, 500 05
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Klatovy, 339 38
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Opava, 746 01
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Ostrava-Trebovice, 722 00
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Pardubice, 530 02
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Pilsen, 305 99
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Prague, 128 08
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Prague, 130 00
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Uherské Hradiště, 686 01
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Zlín, 760 01
Brazil9 sites
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Brasília, Federal District, 71625-009
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Curitiba, Paraná, 80030-110
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Fortaleza, Ceará, 60115-282
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Goiânia, Goiás, 74070-040
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Recife, Pernambuco, 52020-010
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Rio de Janeiro, 22271-100
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São Paulo, 04266-010
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São Paulo, 05437-010
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Vitória, Espírito Santo, 29055-450
Greece9 sites
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Athens, 11525
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Athens, 11526
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Athens, 11527
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Athens, 14561
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Athens, 16673
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Larissa, 41110
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Thessaloniki, 54636
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Thessaloniki, 56403
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Thessaloniki, 56429
Guatemala9 sites
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Antigua Guatemala, Departamento de Sacatepéquez, 03001
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Guatemala City, 01001
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Guatemala City, 01007
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Guatemala City, 01009
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Guatemala City, 01010
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Guatemala City, 01012
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Guatemala City, 01014
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Guatemala City, 01015
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Guatemala City, 01052
Mexico9 sites
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Ciudad Obregón, Sonora, 85000
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León, Guanajuato, 37000
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León, Guanajuato, 37520
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Mexicali, Baja California Norte, 21100
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Mexicalli, Baja California Norte, 21200
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Mexico City, Mexico City, 06100
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Mexico City, Mexico City, 06700
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Monterrey, Nuevo León, 64460
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Querétaro City, Querétaro, 76000
Denmark8 sites
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Aalborg, 9000
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Århus C, 8000
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Ballerup Municipality, 2750
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Glostrup Municipality, 2600
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Hvidovre, 2650
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Køge, 4600
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Odense, 5000
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Vejle, 7100
France8 sites
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Bordeaux, 33076
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Cahors, 46005
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Lille, 59037
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Lyon Cédex 3, 69437
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Orléans, 45067
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Saint-Priest-en-Jarez, 42270
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Toulouse, 31059
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Vandœuvre-lès-Nancy, 54511
South Korea8 sites
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Daegu, 700-712
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Guri-si, 471-701
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Gwangju, 501-757
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Incheon, 405-760
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Seoul, 110-744
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Seoul, 120-752
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Seoul, 136-705
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Suwon-si, Gyeonggi-do, 443-380
Spain8 sites
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A Coruña, Galicia, 15006
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Barcelona, Catalonia, 08003
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Granada, Andalusia, 18012
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Madrid, 28006
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Madrid, 28046
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Sant Joan Despí, Catalonia, 08970
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Santander, Cantabria, 39008
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Seville, Andalusia, 41009
Argentina7 sites
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Buenos Aires, C1012AAR
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Ciudad Autonoma de Buenos Aires, Buenos Aires, 1114
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Ciudad Autonoma de Buenos Aires, Buenos Aires, C1128AAF
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Ciudad Autonoma de Buenos Aires, Buenos Aires, C1430CKE
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Córdoba, Córdoba Province, X5000BNB
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Mar del Plata, Buenos Aires, B7600DHK
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Quilmes, Buenos Aires, B1878DVB
Australia7 sites
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Box Hill, Victoria, 3128
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Darlinghurst, New South Wales, 2010
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Geelong, Victoria, 3220
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Heidelberg West, Victoria, 3081
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Kogarah, New South Wales, 2217
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Parkville, Victoria, 3050
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Randwick, New South Wales, 2031
Bulgaria7 sites
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Plovdiv, 4002
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Sofia, 1202
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Sofia, 1421
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Sofia, 1431
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Sofia, 1504
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Sofia, 1612
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Sofia, 1709
Colombia7 sites
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Barranquilla, Atlántico, 08001000
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Bogota, Cundinamarca, 11001000
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Bogota, Cundinamarca, 110221
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Bogota, Cundinamarca
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Bogotá, 11001000
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Bucaramanga, 68003
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Medellín, Antioquia, 050021
Slovakia7 sites
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Banská Bystrica, 974 01
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Bratislava, 813 69
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Bratislava, 826 06
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Kosice-Saca, 040 15
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Lučenec, 984 01
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Piešťany, 921 12
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Trenčín, 911 01
Belgium6 sites
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Bruges, 8000
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Brussels, 1000
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Genk, 3600
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Ghent, 9000
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Leuven, 3000
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Liège, 4020
Romania6 sites
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Bucharest, 011172
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Bucharest, 011863
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Bucharest, 020125
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Bucharest, 030463
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Oradea, 410028
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Târgu Mureş, 540142
South Africa6 sites
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Johannesburg, Gauteng, 2196
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Parow, Western Cape, 7500
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Pretoria, Gauteng, 0181
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Pretoria, Gauteng, 0184
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Somerset West, Western Cape, 7130
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Tygerberg, 7505
Israel5 sites
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Bnei Brak, 51108
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Haifa, 31096
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Jerusalem, 71713
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Jerusalem, 91007
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Tel Aviv, 61999
Dominican Republic4 sites
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Santiago de los Caballeros, Santiago Province, 51000
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Santo Domingo, Nacional, 10124
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Santo Domingo, Nacional, 10514
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Santo Domingo, 10605
Finland4 sites
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Helsinki, 00100
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Jyväskylä, 40100
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Kuopio, 70211
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Turku, 20100
Norway4 sites
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Elverum, 2408
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Hamar, 2317
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Oslo, 0050
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Stavanger, 4005
Sweden4 sites
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Linköping, 581 85
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Mölndal, 431 80
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Stockholm, 141 86
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Umeå, 907 36
Turkey (Türkiye)4 sites
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Adana, 01330
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Istanbul, 34093
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Istanbul, 34890
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Izmir, 35100
Austria3 sites
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Graz, 8036
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Linz, 4010
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Vienna, 1060
Latvia3 sites
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Liepāja, 3401
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Riga, 1011
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Riga, 1012
Netherlands3 sites
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Leiden, 2333 ZA
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Rotterdam, 3015 CE
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Venlo, 5912 BL
Peru3 sites
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Lima, Lima 27
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Lima, Lima 33
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Lima, Lima11
New Zealand2 sites
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Christchurch, 8022
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Grafton, Auckland, 1023
About this study
Official title: A Multicenter, International, Randomized, Double-blind, Alendronate-controlled Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis
The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis.
Read the detailed description
In this trial, women were randomly assigned in a 1:1 ratio to receive monthly subcutaneous romosozumab or weekly oral alendronate for 12 months. Randomization was stratified according to age (<75 vs. ≥75 years). After completion of the double-blind treatment period, all the participants were to receive open-label weekly oral alendronate until the end of the trial, with blinding to the initial treatment assignment maintained.
The primary analysis was performed when clinical fracture events had been confirmed in at least 330 participants and all the participants had completed the month 24 visit. The study was to continue in an event-driven manner until at least 440 participants experienced a nonvertebral fracture or if the superiority of romosozumab was proven for nonvertebral fractures at the primary analysis.
- Conditions
- Postmenopausal Women With Osteoporosis
- Being tested
- Romosozumab, Alendronate, Placebo to Romosozumab, Placebo to Alendronate
- Keywords
- Osteoporosis, Osteoporosis-postmenopausal, Bone Diseases-Metabolic, Bone Diseases, Musculoskeletal Diseases
- Medical subject headings
- Osteoporosis, Osteoporosis, Postmenopausal, Bone Diseases, Metabolic, Bone Diseases, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RomosozumabBiological
Also called AMG 785, Evenity
Romosozumab 210 mg administered by subcutaneous injection once a month during the double-blind treatment phase.
AlendronateDrug
Also called Fosamax
Alendronate 70 mg tablet taken once a week
Placebo to RomosozumabDrug
Administered by subcutaneous injection once a month during the double-blind treatment phase.
Placebo to AlendronateDrug
Matching placebo tablet taken once a week during the double-blind treatment phase.
| Study group | Role | What they receive |
|---|---|---|
| Alendronate/Alendronate | Active comparator | Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study. Receives: Drug: Alendronate; Drug: Placebo to Romosozumab |
| Romosozumab/Alendronate | Experimental | Participants received 210 mg romosozumab subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study. Receives: Biological: Romosozumab; Drug: Alendronate; Drug: Placebo to Alendronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With New Vertebral Fractures Through Month 24
All fracture assessments were performed by blinded central imaging readers.
New vertebral fractures occurred when there was ≥ 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4 using the Genant Semiquantitative Scoring method based on assessment of x-rays according to the following scale:
- Grade 0 (Normal) = no fracture;
- Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior);
- Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height;
- Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height.
Incident vertebral fractures were confirmed by a second independent reader using the Semiquantitative method.
Measured: 24 months
Percentage of Participants With a Clinical Fracture at the Primary Analysis
All fracture assessments were performed by blinded central imaging readers. Clinical fractures included clinical vertebral and nonvertebral fractures (excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges) that were associated with signs and/or symptoms indicative of a fracture. Clinical vertebral fractures were included regardless of trauma severity or pathologic fractures; nonvertebral fractures associated with high trauma severity or pathologic fractures were excluded.
Measured: The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).
Secondary outcomes (26)
Percentage of Participants With a Nonvertebral Fracture at the Primary Analysis
A nonvertebral fracture was defined as a documented fracture excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded.
Measured: The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).
Percentage of Participants With Any Fracture at the Primary Analysis
All fractures include any osteoporotic nonvertebral fractures that are not associated with high trauma severity or pathologic fractures and new or worsening vertebral fractures regardless of trauma severity or pathologic fractures.
Measured: The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).
Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 24
A new or worsening vertebral fracture was identified when there was a ≥ 1 grade increase from the previous grade in any vertebra from T4 to L4 according to the Genant Semiquantitative Scoring method based on assessment of x-rays according to the following scale:
- Grade 0 (Normal) = no fracture;
- Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior);
- Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height;
- Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height.
Incident vertebral fractures were confirmed by a second independent reader using the Semiquantitative method.
Measured: 24 months
Percentage of Participants With a Major Nonvertebral Fracture at the Primary Analysis
Major nonvertebral fractures included a subset of nonvertebral fractures including pelvis, distal femur (ie, femur excluding hip), proximal tibia (ie, tibia excluding ankle), ribs, proximal humerus (ie, humerus excluding elbow), forearm, and hip.
Measured: The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).
Percentage of Participants With a Hip Fracture at the Primary Analysis
Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter.
Measured: The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).
Percentage of Participants With Multiple New or Worsening Vertebral Fractures Through Month 24
A new or worsening vertebral fracture was identified when there was a ≥ 1 grade increase from the previous grade in any vertebra from T4 to L4 according to the Genant Semiquantitative Scoring method. A participant had multiple new or worsening vertebral fractures when there were ≥ 2 vertebrae from T4 to L4 with ≥ 1 grade increase from the previous grade. The multiple new or worsening vertebral fractures need not have occurred at the same visit. Incident vertebral fractures were confirmed by a second independent reader.
Measured: 24 months
Percentage of Participants With a Clinical Fracture Through Month 24
Clinical fractures included clinical vertebral and nonvertebral fractures (excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges) that were associated with signs and/or symptoms indicative of a fracture. Clinical vertebral fractures were included regardless of trauma severity or pathologic fractures; nonvertebral fractures associated with high trauma severity or pathologic fractures were excluded.
Measured: 24 months
Percentage of Participants With a Nonvertebral Fracture Through Month 24
A nonvertebral fracture was defined as a documented fracture excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded.
Measured: 24 months
Percentage of Participants With a Hip Fracture Through Month 24
Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter.
Measured: 24 months
Percentage of Participants With a Clinical Vertebral Fracture Through Month 24
A clinical vertebral fracture is a new or worsening vertebral fracture assessed at either a scheduled or unscheduled visit and associated with any signs and/or symptoms of back pain indicative of a fracture, regardless of trauma severity or whether it is pathologic.
Measured: 24 months
Percentage of Participants With a Clinical Fracture Through Month 12
Clinical fractures included clinical vertebral and nonvertebral fractures (excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges) that were associated with signs and/or symptoms indicative of a fracture. Clinical vertebral fractures were included regardless of trauma severity or pathologic fractures; nonvertebral fractures associated with high trauma severity or pathologic fractures were excluded.
Measured: 12 months
Percentage of Participants With New Vertebral Fractures Through Month 12
New vertebral fractures occurred when there was ≥ 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4 using the Genant Semiquantitative Scoring method based on assessment of x-rays according to the following scale:
- Grade 0 (Normal) = no fracture;
- Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior);
- Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height;
- Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height.
Incident vertebral fractures were confirmed by a second independent reader.
Measured: 12 months
Percentage of Participants With Any Fracture Through Month 12
All fractures include any osteoporotic nonvertebral fractures that are not associated with high trauma severity or pathologic fractures and new or worsening vertebral fractures regardless of trauma severity or pathologic fractures.
Measured: 12 months
Percentage of Participants With a Nonvertebral Fracture Through Month 12
A nonvertebral fracture was defined as a fracture present on a copy of radiographs or other diagnostic images such as computerized tomography (CT) or magnetic resonance imaging confirming the fracture within 14 days of reported fracture image date recorded by the study site, and/or documented in a copy of the radiology report, surgical report, or discharge summary, excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded.
Measured: 12 months
Percentage of Participants With a Hip Fracture Through Month 12
Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter.
Measured: 12 months
Percentage of Participants With a Major Osteoporotic Fracture Through Month 12
Major osteoporotic fractures included clinical vertebral fractures and fractures of the hip, forearm and humerus. Fractures associated with high trauma severity or pathologic fractures were excluded.
Measured: 12 months
Percentage of Participants With a Clinical Vertebral Fracture Through Month 12
A clinical vertebral fracture is a new or worsening vertebral fracture assessed at either a scheduled or unscheduled visit and associated with any signs and/or symptoms of back pain indicative of a fracture, regardless of trauma severity or whether it is pathologic.
Measured: 12 months
Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 24
Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Measured: Baseline and month 24
Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 24
Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Measured: Baseline and month 24
Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at at Month 24
Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Measured: Baseline and month 24
Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 12
Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Measured: Baseline and month 12
Percent Change From Baseline in Bone Mineral Density at the Total Hip at Month 12
Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Measured: Baseline and month 12
Percent Change From Baseline in Bone Mineral Density at the Femoral Neck at Month 12
Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Measured: Baseline and month 12
Percent Change From Baseline in Bone Mineral Density of the Lumbar Spine at Month 36
Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Measured: Baseline and month 36
Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 36
Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Measured: Baseline and month 36
Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at Month 36
Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Measured: Baseline and month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2012 (estimated)
- Study start4 May 2012
- Primary completion27 Feb 2017
- Study completion29 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal Women With OsteoporosisStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4,093 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01631214
- Sponsor's protocol ID
- 20110142
- Other IDs
- 2011-003142-41
- Acronym
- ARCH
- Status last verified
- Feb 2025
- First submitted
- 24 May 2012
- Last updated
- 21 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Saag KG, Petersen J, Brandi ML, Karaplis AC, Lorentzon M, Thomas T, Maddox J, Fan M, Meisner PD, Grauer A. Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis. N Engl J Med. 2017 Oct 12;377(15):1417-1427. doi: 10.1056/NEJMoa1708322. Epub 2017 Sep 11.
PubMed 28892457Cosman F, Lewiecki EM, Ebeling PR, Hesse E, Napoli N, Matsumoto T, Crittenden DB, Rojeski M, Yang W, Libanati C, Ferrari S. T-Score as an Indicator of Fracture Risk During Treatment With Romosozumab or Alendronate in the ARCH Trial. J Bone Miner Res. 2020 Jul;35(7):1333-1342. doi: 10.1002/jbmr.3996. Epub 2020 May 22.
PubMed 32445228Lau EMC, Dinavahi R, Woo YC, Wu CH, Guan J, Maddox J, Tolman C, Yang W, Shin CS. Romosozumab or alendronate for fracture prevention in East Asian patients: a subanalysis of the phase III, randomized ARCH study. Osteoporos Int. 2020 Apr;31(4):677-685. doi: 10.1007/s00198-020-05324-0. Epub 2020 Feb 11.
PubMed 32047951Miller PD, Adachi JD, Albergaria BH, Cheung AM, Chines AA, Gielen E, Langdahl BL, Miyauchi A, Oates M, Reid IR, Santiago NR, Vanderkelen M, Wang Z, Yu Z. Efficacy and Safety of Romosozumab Among Postmenopausal Women With Osteoporosis and Mild-to-Moderate Chronic Kidney Disease. J Bone Miner Res. 2022 Aug;37(8):1437-1445. doi: 10.1002/jbmr.4563. Epub 2022 May 20.
PubMed 35466448Brown JP, Engelke K, Keaveny TM, Chines A, Chapurlat R, Foldes AJ, Nogues X, Civitelli R, De Villiers T, Massari F, Zerbini CAF, Wang Z, Oates MK, Recknor C, Libanati C. Romosozumab improves lumbar spine bone mass and bone strength parameters relative to alendronate in postmenopausal women: results from the Active-Controlled Fracture Study in Postmenopausal Women With Osteoporosis at High Risk (ARCH) trial. J Bone Miner Res. 2021 Nov;36(11):2139-2152. doi: 10.1002/jbmr.4409. Epub 2021 Aug 10.
PubMed 34190361McClung MR, Betah D, Leder BZ, Kendler DL, Oates M, Timoshanko J, Wang Z. Romosozumab improves microarchitecture as assessed by tissue thickness-adjusted trabecular bone score in postmenopausal women with osteoporosis. J Bone Miner Res. 2025 Feb 2;40(2):193-200. doi: 10.1093/jbmr/zjae194.
PubMed 39656908Ferrari S, Betah D, Feldman RG, Langdahl BL, Oates M, Timoshanko J, Wang Z, Dhaliwal R. Romosozumab Improves Tissue Thickness-Adjusted Trabecular Bone Score in Women With Osteoporosis and Diabetes. J Clin Endocrinol Metab. 2025 Sep 16;110(10):2861-2868. doi: 10.1210/clinem/dgae862.
PubMed 39854280Lane J, Langdahl B, Stone M, Kurth A, Oates M, Timoshanko J, Wang Z, Libanati C, Cosman F. Romosozumab in patients who experienced an on-study fracture: post hoc analyses of the FRAME and ARCH phase 3 trials. Osteoporos Int. 2024 Jul;35(7):1195-1204. doi: 10.1007/s00198-024-07049-w. Epub 2024 Apr 4.
PubMed 38573517
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, International, Randomized, Double-blind, Alendronate-controlled Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis
- ClinicalTrials.gov ID
- NCT01631214
- Acronym / sponsor ID
- ARCH / 20110142
- Conditions
- Postmenopausal Women With Osteoporosis
- Keywords
- Osteoporosis, Osteoporosis-postmenopausal, Bone Diseases-Metabolic, Bone Diseases, Musculoskeletal Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,093 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 4 May 2012 (actual)
- Primary completion
- 27 Feb 2017 (actual)
- Study completion
- 29 Jun 2017 (actual)
- First posted
- 29 Jun 2012 (estimated)
- Results
- Posted 12 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis.
Detailed description
In this trial, women were randomly assigned in a 1:1 ratio to receive monthly subcutaneous romosozumab or weekly oral alendronate for 12 months. Randomization was stratified according to age (<75 vs. ≥75 years). After completion of the double-blind treatment period, all the participants were to receive open-label weekly oral alendronate until the end of the trial, with blinding to the initial treatment assignment maintained.
The primary analysis was performed when clinical fracture events had been confirmed in at least 330 participants and all the participants had completed the month 24 visit. The study was to continue in an event-driven manner until at least 440 participants experienced a nonvertebral fracture or if the superiority of romosozumab was proven for nonvertebral fractures at the primary analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alendronate/Alendronate | Active comparator | Drug: Alendronate, Drug: Placebo to RomosozumabParticipants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study. |
| Romosozumab/Alendronate | Experimental | Biological: Romosozumab, Drug: Alendronate, Drug: Placebo to AlendronateParticipants received 210 mg romosozumab subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study. |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Postmenopausal women who meet at least one of the following bone mineral density (BMD) and fracture criteria:
- BMD T-score at the total hip or femoral neck of ≤ -2.50 and EITHER:
- BMD T-score at the total hip or femoral neck of ≤ -2.00 and EITHER:
Key exclusion criteria (8 listed)
- History of metabolic or bone disease (except osteoporosis)
- Use of agents affecting bone metabolism
- Vitamin D insufficiency
- History of solid organ or bone marrow transplants
- Hyper- or hypocalcemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RomosozumabAlso: AMG 785, EvenityRomosozumab 210 mg administered by subcutaneous injection once a month during the double-blind treatment phase. | Biological | Romosozumab/Alendronate |
| AlendronateAlso: FosamaxAlendronate 70 mg tablet taken once a week | Drug | Alendronate/Alendronate, Romosozumab/Alendronate |
| Placebo to RomosozumabAdministered by subcutaneous injection once a month during the double-blind treatment phase. | Drug | Alendronate/Alendronate |
| Placebo to AlendronateMatching placebo tablet taken once a week during the double-blind treatment phase. | Drug | Romosozumab/Alendronate |
Primary outcome
Percentage of Participants With New Vertebral Fractures Through Month 24
Time frame: 24 months
All fracture assessments were performed by blinded central imaging readers. New vertebral fractures occurred when there was ≥ 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4 using the Genant Semiquantitative Scoring method based on assessment of x-rays according to the following scale: * Grade 0 (Normal) = no fracture; * Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior); * Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height; * Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height. Incident vertebral fractures were confirmed by a second independent reader using the Semiquantitative method.
Percentage of Participants With a Clinical Fracture at the Primary Analysis
Time frame: The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).
All fracture assessments were performed by blinded central imaging readers. Clinical fractures included clinical vertebral and nonvertebral fractures (excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges) that were associated with signs and/or symptoms indicative of a fracture. Clinical vertebral fractures were included regardless of trauma severity or pathologic fractures; nonvertebral fractures associated with high trauma severity or pathologic fractures were excluded.
26 secondary outcomes
Percentage of Participants With a Nonvertebral Fracture at the Primary Analysis
Time frame: The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).
Percentage of Participants With Any Fracture at the Primary Analysis
Time frame: The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).
Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 24
Time frame: 24 months
Percentage of Participants With a Major Nonvertebral Fracture at the Primary Analysis
Time frame: The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).
Percentage of Participants With a Hip Fracture at the Primary Analysis
Time frame: The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).
Percentage of Participants With Multiple New or Worsening Vertebral Fractures Through Month 24
Time frame: 24 months
Percentage of Participants With a Clinical Fracture Through Month 24
Time frame: 24 months
Percentage of Participants With a Nonvertebral Fracture Through Month 24
Time frame: 24 months
Percentage of Participants With a Hip Fracture Through Month 24
Time frame: 24 months
Percentage of Participants With a Clinical Vertebral Fracture Through Month 24
Time frame: 24 months
Percentage of Participants With a Clinical Fracture Through Month 12
Time frame: 12 months
Percentage of Participants With New Vertebral Fractures Through Month 12
Time frame: 12 months
Percentage of Participants With Any Fracture Through Month 12
Time frame: 12 months
Percentage of Participants With a Nonvertebral Fracture Through Month 12
Time frame: 12 months
Percentage of Participants With a Hip Fracture Through Month 12
Time frame: 12 months
Percentage of Participants With a Major Osteoporotic Fracture Through Month 12
Time frame: 12 months
Percentage of Participants With a Clinical Vertebral Fracture Through Month 12
Time frame: 12 months
Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 24
Time frame: Baseline and month 24
Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 24
Time frame: Baseline and month 24
Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at at Month 24
Time frame: Baseline and month 24
Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 12
Time frame: Baseline and month 12
Percent Change From Baseline in Bone Mineral Density at the Total Hip at Month 12
Time frame: Baseline and month 12
Percent Change From Baseline in Bone Mineral Density at the Femoral Neck at Month 12
Time frame: Baseline and month 12
Percent Change From Baseline in Bone Mineral Density of the Lumbar Spine at Month 36
Time frame: Baseline and month 36
Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 36
Time frame: Baseline and month 36
Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at Month 36
Time frame: Baseline and month 36
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28892457Saag KG, Petersen J, Brandi ML, Karaplis AC, Lorentzon M, Thomas T, Maddox J, Fan M, Meisner PD, Grauer A. Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis. N Engl J Med. 2017 Oct 12;377(15):1417-1427. doi: 10.1056/NEJMoa1708322. Epub 2017 Sep 11.
- Background: PubMed 32445228Cosman F, Lewiecki EM, Ebeling PR, Hesse E, Napoli N, Matsumoto T, Crittenden DB, Rojeski M, Yang W, Libanati C, Ferrari S. T-Score as an Indicator of Fracture Risk During Treatment With Romosozumab or Alendronate in the ARCH Trial. J Bone Miner Res. 2020 Jul;35(7):1333-1342. doi: 10.1002/jbmr.3996. Epub 2020 May 22.
- Background: PubMed 32047951Lau EMC, Dinavahi R, Woo YC, Wu CH, Guan J, Maddox J, Tolman C, Yang W, Shin CS. Romosozumab or alendronate for fracture prevention in East Asian patients: a subanalysis of the phase III, randomized ARCH study. Osteoporos Int. 2020 Apr;31(4):677-685. doi: 10.1007/s00198-020-05324-0. Epub 2020 Feb 11.
- Background: PubMed 35466448Miller PD, Adachi JD, Albergaria BH, Cheung AM, Chines AA, Gielen E, Langdahl BL, Miyauchi A, Oates M, Reid IR, Santiago NR, Vanderkelen M, Wang Z, Yu Z. Efficacy and Safety of Romosozumab Among Postmenopausal Women With Osteoporosis and Mild-to-Moderate Chronic Kidney Disease. J Bone Miner Res. 2022 Aug;37(8):1437-1445. doi: 10.1002/jbmr.4563. Epub 2022 May 20.
- Background: PubMed 34190361Brown JP, Engelke K, Keaveny TM, Chines A, Chapurlat R, Foldes AJ, Nogues X, Civitelli R, De Villiers T, Massari F, Zerbini CAF, Wang Z, Oates MK, Recknor C, Libanati C. Romosozumab improves lumbar spine bone mass and bone strength parameters relative to alendronate in postmenopausal women: results from the Active-Controlled Fracture Study in Postmenopausal Women With Osteoporosis at High Risk (ARCH) trial. J Bone Miner Res. 2021 Nov;36(11):2139-2152. doi: 10.1002/jbmr.4409. Epub 2021 Aug 10.
- Background: PubMed 39656908McClung MR, Betah D, Leder BZ, Kendler DL, Oates M, Timoshanko J, Wang Z. Romosozumab improves microarchitecture as assessed by tissue thickness-adjusted trabecular bone score in postmenopausal women with osteoporosis. J Bone Miner Res. 2025 Feb 2;40(2):193-200. doi: 10.1093/jbmr/zjae194.
- Background: PubMed 39854280Ferrari S, Betah D, Feldman RG, Langdahl BL, Oates M, Timoshanko J, Wang Z, Dhaliwal R. Romosozumab Improves Tissue Thickness-Adjusted Trabecular Bone Score in Women With Osteoporosis and Diabetes. J Clin Endocrinol Metab. 2025 Sep 16;110(10):2861-2868. doi: 10.1210/clinem/dgae862.
- Derived from this study: PubMed 38573517Lane J, Langdahl B, Stone M, Kurth A, Oates M, Timoshanko J, Wang Z, Libanati C, Cosman F. Romosozumab in patients who experienced an on-study fracture: post hoc analyses of the FRAME and ARCH phase 3 trials. Osteoporos Int. 2024 Jul;35(7):1195-1204. doi: 10.1007/s00198-024-07049-w. Epub 2024 Apr 4.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
316 sites in 42 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Romosozumab and Alendronate in people with Postmenopausal Women With Osteoporosis, run by Amgen at 316 sites in 42 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 316 sites in United States, Poland, Germany, United Kingdom, Russia and 37 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With New Vertebral Fractures Through Month 24 (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01631214, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.