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Postmenopausal OsteoporosisPhase 3STRUCTURENCT01796301

An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women

A Phase 3 study testing Romozosumab and Teriparatide in people with Postmenopausal Osteoporosis, run by Amgen at 50 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of the study was to evaluate the effect of 12 months of treatment with romosozumab compared with teriparatide on total hip bone mineral density (BMD) in postmenopausal women with osteoporosis who were previously treated with bisphosphonate therapy. Read more about this study

Who is it for?
Ages 55 to 90 years, women only
Conditions the study is for
Postmenopausal Osteoporosis
What is being tested?
Romozosumab and Teriparatide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
436 participants
Where
50 sitesin 11 countries
Study dates
31 Jan 2013to 14 May 2015
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, aged ≥ 55 to ≤ 90.
  • Received oral bisphosphonate therapy for at least 3 years immediately prior to screening
  • BMD T-score ≤ -2.50 at the lumbar spine, total hip or femoral neck
  • History of nonvertebral fracture after age 50, or vertebral fracture.

Who cannot join

  • Use of other agents affecting bone metabolism including Strontium ranelate, fluoride (for osteoporosis), odanacatib (MK-0822) or any other cathepsin K inhibitor, IV bisphosphonates, denosumab, teriparatide (TPTD) or any parathyroid hormone (PTH) analogs, Systemic oral or transdermal estrogen, selective estrogen receptor modulators (SERMs), activated vitamin D3, vitamin K2, calcitonin, tibolone, cinacalcet, systemic glucocorticosteroids:
  • History of metabolic or bone disease (except osteoporosis) that may interfere with the interpretation of study results, such as sclerosteosis, Paget's disease, rheumatoid arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing's disease, hyperprolactinemia, and malabsorption syndrome.
  • Vitamin D insufficiency, defined as 25 (OH) vitamin D levels < 20 ng/mL, as determined by the central laboratory.
  • Current hyper- or hypocalcemia
  • Current, uncontrolled hyper- or hypothyroidism

Trial locations and contacts

50 sites in 11 countries.

50 sites in 11 countries

Denmark7 sites

  • Research Site

    Aalborg, 9000

  • Research Site

    Aarhus C, 8000

  • Research Site

    Ballerup Municipality, 2750

  • Research Site

    Esbjerg, 6700

  • Research Site

    Hillerød, 3400

  • Research Site

    Hvidovre, 2650

  • Research Site

    Odense, 5000

Other trials in Denmark

Spain6 sites

  • Research Site

    Barcelona, Catalonia, 08041

  • Research Site

    Granada, Andalusia, 18012

  • Research Site

    LHospitalet de Llobregat, Catalonia, 08907

  • Research Site

    Madrid, 28041

  • Research Site

    Madrid, 28046

  • Research Site

    Pozuelo de Alarcón, Madrid, 28223

Other trials in Spain

United Kingdom6 sites

  • Research Site

    Cardiff, CF14 5GJ

  • Research Site

    Chorley, PR7 7NA

  • Research Site

    Liverpool, L22 0LG

  • Research Site

    Northwood, HA6 2RN

  • Research Site

    Reading, RG2 0TG

  • Research Site

    Sidcup, DA14 6LT

Other trials in United Kingdom

United States5 sites

  • Research Site

    Bethesda, Maryland, 20817

  • Research Site

    Boston, Massachusetts, 02114

  • Research Site

    Boston, Massachusetts, 02131

  • Research Site

    Detroit, Michigan, 48236

  • Research Site

    Gainesville, Georgia, 30501

Other trials in United States

Canada5 sites

  • Research Site

    Calgary, Alberta, T2N 4Z6

  • Research Site

    Québec, Quebec, G1V 3M7

  • Research Site

    Toronto, Ontario, M5C 2T2

  • Research Site

    Toronto, Ontario, M5G 2C4

  • Research Site

    Vancouver, British Columbia, V6H 3X8

Other trials in Canada

Czechia5 sites

  • Research Site

    Brno, 602 00

  • Research Site

    Ostrava, 702 00

  • Research Site

    Pilsen, 305 99

  • Research Site

    Praha 11 - Chodov, 148 00

  • Research Site

    Uherské Hradiště, 686 01

Other trials in Czechia

Belgium4 sites

  • Research Site

    Genk, 3600

  • Research Site

    Ghent, 9000

  • Research Site

    Leuven, 3000

  • Research Site

    Liège, 4000

Other trials in Belgium

Poland4 sites

  • Research Site

    Gdynia, 81-384

  • Research Site

    Katowice, 40-040

  • Research Site

    Warsaw, 01-192

  • Research Site

    Wroclaw, 50-088

Other trials in Poland

Argentina3 sites

  • Research Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1012AAR

  • Research Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1128AAF

  • Research Site

    Córdoba, Córdoba Province, X5000BNB

Other trials in Argentina

Hungary3 sites

  • Research Site

    Budapest, 1036

  • Research Site

    Budapest, 1083

  • Research Site

    Budapest, 1123

Other trials in Hungary

Colombia2 sites

  • Research Site

    Barranquilla, Atlántico, 08001000

  • Research Site

    Medellín, Antioquia

Other trials in Colombia

About this study

Official title: An Open-label, Randomized, Teriparatide-controlled Study to Evaluate the Effect of Treatment With Romosozumab in Postmenopausal Women With Osteoporosis Previously Treated With Bisphosphonate Therapy

The primary objective of the study was to evaluate the effect of 12 months of treatment with romosozumab compared with teriparatide on total hip bone mineral density (BMD) in postmenopausal women with osteoporosis who were previously treated with bisphosphonate therapy.

Being tested
Romozosumab, Teriparatide
Keywords
Postmenopausal Osteoporosis
Medical subject headings
Osteoporosis, Postmenopausal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RomozosumabDrug

    Also called AMG 785

    Administered by subcutaneous injection once a month.

  • TeriparatideDrug

    Also called Forteo, Forsteo

    Administered by subcutaneous injection once a day.

Study groups in NCT01796301
Study groupRoleWhat they receive
RomosozumabExperimentalParticipants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
Receives: Drug: Romozosumab
TeriparatideActive comparatorParticipants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months.
Receives: Drug: Teriparatide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change From Baseline Through Month 12 in Total Hip Bone Mineral Density (BMD)

    Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). Percent change from baseline through month 12 is the average of the treatment effect at months 6 and 12.

    Measured: Baseline, month 6 and month 12

Secondary outcomes (14)

  1. Percent Change From Baseline in Total Hip BMD at Month 6

    Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).

    Measured: Baseline and month 6

  2. Percent Change From Baseline in Total Hip BMD at Month 12

    Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).

    Measured: Baseline and month 12

  3. Percent Change From Baseline in Cortical BMD by Quantitative Computed Tomography (QCT) at the Total Hip at Month 6

    Cortical BMD was measured by quantitative computed tomography (QCT) at the total hip.

    Measured: Baseline and month 6

  4. Percent Change From Baseline in Cortical BMD by QCT at the Total Hip at Month 12

    Cortical BMD was measured by quantitative computed tomography (QCT) at the total hip.

    Measured: Baseline and month 12

  5. Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 6

    Integral BMD was measured by quantitative computed tomography (QCT) at the total hip.

    Measured: Baseline and month 6

  6. Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 12

    Integral BMD was measured by quantitative computed tomography (QCT) at the total hip.

    Measured: Baseline and month 12

  7. Percent Change From Baseline in Estimated Strength at the Total Hip at Month 6

    Total hip estimated strength was assessed by finite element analysis (FEA) of QCT scans.

    Measured: Baseline and month 6

  8. Percent Change From Baseline in Estimated Strength at the Total Hip at Month 12

    Total hip estimated strength was assessed by finite element analysis (FEA) of QCT scans.

    Measured: Baseline and month 12

  9. Percent Change From Baseline in Total Hip Integral Bone Mineral Content (BMC) by QCT at Month 6

    Total hip integral BMC was measured using quantitative computed tomography (QCT).

    Measured: Baseline and month 6

  10. Percent Change From Baseline in Total Hip Integral Bone Mineral Content (BMC) by QCT at Month 12

    Total hip integral BMC was measured using quantitative computed tomography (QCT).

    Measured: Baseline and month 12

  11. Percent Change From Baseline in Femoral Neck BMD at Month 6

    Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).

    Measured: Baseline and month 6

  12. Percent Change From Baseline in Femoral Neck BMD at Month 12

    Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).

    Measured: Baseline and month 12

  13. Percent Change From Baseline in Lumbar Spine BMD at Month 6

    Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).

    Measured: Baseline and month 6

  14. Percent Change From Baseline in Lumbar Spine BMD at Month 12

    Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).

    Measured: Baseline and month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2013 (estimated)
  2. Study start31 Jan 2013
  3. Primary completion14 May 2015
  4. Study completion14 May 2015

Resources

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
None (open label)
Enrolment
436 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01796301
Sponsor's protocol ID
20080289
Other IDs
2012-002948-24
Acronym
STRUCTURE
Status last verified
Nov 2022
First submitted
19 Feb 2013
Last updated
29 Nov 2022
Data monitoring committee
No

Publications

  • Langdahl BL, Libanati C, Crittenden DB, Bolognese MA, Brown JP, Daizadeh NS, Dokoupilova E, Engelke K, Finkelstein JS, Genant HK, Goemaere S, Hyldstrup L, Jodar-Gimeno E, Keaveny TM, Kendler D, Lakatos P, Maddox J, Malouf J, Massari FE, Molina JF, Ulla MR, Grauer A. Romosozumab (sclerostin monoclonal antibody) versus teriparatide in postmenopausal women with osteoporosis transitioning from oral bisphosphonate therapy: a randomised, open-label, phase 3 trial. Lancet. 2017 Sep 30;390(10102):1585-1594. doi: 10.1016/S0140-6736(17)31613-6. Epub 2017 Jul 26.

    PubMed 28755782

  • Takada J, Dinavahi R, Miyauchi A, Hamaya E, Hirama T, Libanati C, Nakamura Y, Milmont CE, Grauer A. Relationship between P1NP, a biochemical marker of bone turnover, and bone mineral density in patients transitioned from alendronate to romosozumab or teriparatide: a post hoc analysis of the STRUCTURE trial. J Bone Miner Metab. 2020 May;38(3):310-315. doi: 10.1007/s00774-019-01057-1. Epub 2019 Nov 9.

    PubMed 31707465

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Romozosumab and Teriparatide in people with Postmenopausal Osteoporosis, run by Amgen at 50 sites in 11 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 4 inclusion and 5 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 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in Denmark, Spain, United Kingdom, United States, Canada and 6 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 8 Nov 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?

Percent Change From Baseline Through Month 12 in Total Hip Bone Mineral Density (BMD) (time frame: Baseline, month 6 and month 12). 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 NCT01796301, which also lists 2 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 29 Nov 2022.

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