Postmenopausal OsteoporosisPhase 4VERONCT01709110
VERtebral Fracture Treatment Comparisons in Osteoporotic Women
A Phase 4 study testing Teriparatide, Risedronate and Calcium in people with Postmenopausal Osteoporosis, run by Eli Lilly and Company at 103 sites in 15 countries.
Trial summary
The primary purpose of participation in this study is to answer whether teriparatide is superior to risedronate in reducing the occurrence of new vertebral fractures during 24 months of therapy. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- Teriparatide, Risedronate and Calcium
- 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
- 1,366 participants
- Where
- 103 sitesin 15 countries
- Study dates
- Oct 2012to Jul 2016
- Phase
- Phase 4
- 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 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women with osteoporosis, as defined by low bone mineral density (BMD), i.e. anterior-posterior lumbar spine, total hip or femoral neck BMD ≥1.5 standard deviations below the average BMD for young, healthy, non-Hispanic, Caucasian women
- A minimum of 2 moderate or 1 severe vertebral fragility fractures (confirmed by central reader) were required
Who cannot join
- Increased risk of osteosarcoma
- History of unresolved skeletal diseases that affect bone metabolism
- History of atypical subtrochanteric or diaphyseal femoral fractures
- Abnormally high or low calcium levels
- Abnormally high parathyroid hormone (PTH) levels
- Severe vitamin D deficiency
Show all 15Show fewer
- Abnormal thyroid function not corrected by therapy
- History of malignant neoplasms in the last 5 years
- Active liver disease, clinical jaundice
- Significant impairment of hepatic or renal function
- History of nephro- or urolithiasis
- Previous or planned kypho- or vertebroplasty
- Active or risk for osteonecrosis of the jaw
- Active or recent history of upper gastrointestinal disorders
- Unable to stand or sit in the upright position for at least 30 minutes
Trial locations and contacts
103 sites in 15 countries.
103 sites in 15 countries
United States30 sites
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Albuquerque, New Mexico, 87106
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Asheville, North Carolina, 28803
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Bend, Oregon, 97701
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Bethesda, Maryland, 20817
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Birmingham, Alabama, 35294
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Clifton, New Jersey, 07012
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Concord, California, 94520
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Dallas, Texas, 75231
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Danbury, Connecticut, 06810
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Detroit, Michigan, 48202
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Duncansville, Pennsylvania, 16635
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Evansville, Indiana, 47714
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Fargo, North Dakota, 58103
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Freehold, New Jersey, 07728
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Fresno, California, 93720
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Gainesville, Georgia, 30501
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Greensboro, North Carolina, 27408
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Indianapolis, Indiana, 46202
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Laguna Hills, California, 92653
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Lakewood, Colorado, 80227
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Lancaster, California, 93534
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Madison, Wisconsin, 53705
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Omaha, Nebraska, 68131
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Orlando, Florida, 32804
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Pittsburgh, Pennsylvania, 15213
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Seattle, Washington, 98122
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Spokane, Washington, 99204
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Topeka, Kansas, 66606
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Tustin, California, 92780
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Wyomissing, Pennsylvania, 19610
Belgium9 sites
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Brussels, 1070
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Genk, 3600
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Ghent, 9000
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Gilly, 6060
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Laken, 1020
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Leuven, 3000
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Liège, 4020
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Merksem, 2170
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Mons, 7000
Canada9 sites
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Halifax, Nova Scotia, B3H 1V7
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Hamilton, Ontario, L8N 1Y2
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Kelowna, British Columbia, V1Y3G5
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Montreal, Quebec, H3T 1E2
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Sainte-Foy, Quebec, G1V 3M7
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Saskatoon, Saskatchewan, S7K 0H6
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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
Italy7 sites
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Florence, 50134
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Genova-Nervi, 16167
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Orbassano, 10043
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Padova, 35128
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Rome, 00161
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Torino, 10126
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Valeggio sul Mincio, 37067
France6 sites
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Caen, 14033
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La Crau, 83260
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Lyon, 69003
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Orléans, 45032
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Saint-Etienne, 42055
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Toulouse, 31059
Germany6 sites
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Dresden, 01067
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Frankfurt, 60528
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Hamburg, 22415
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Leipzig, 04103
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Magdeburg, 39110
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Marburg, 35043
Poland6 sites
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Bialystok, 15-351
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Elblag, 82-300
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Lublin, 20-582
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Poznan, 60-218
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Świdnik, 21-040
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Warsaw, 02-118
Spain6 sites
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Alzira, 46600
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Barcelona, 08025
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Cadiz, 11009
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Madrid, 28046
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Sabadell, 08208
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Valencia, 46026
Hungary5 sites
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Budapest, 1094
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Debrecen, 4043
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Eger, 3300
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Kaposvár, 7400
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Szeged, 6720
Austria4 sites
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Graz, 8036
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Hohenems, 6845
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Linz, 4020
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Vienna, A-1060
Czechia4 sites
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České Budějovice, 37005
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Klatovy, 33938
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Prague, 128 08
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Uherské Hradiště, 686 01
Greece4 sites
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Athens, 10676
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Kifissia, 14561
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Pátrai, 26500
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Thessaloniki, 54642
Argentina3 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Buenos Aires, C1128AAF
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Caba, C1425AGC
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Mar del Plata, B7600DHK
Brazil3 sites
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Brasília, 71625-009
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Rio de Janeiro, 22271-100
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São Paulo, 05437-010
Puerto Rico1 site
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
San Juan, 00918
About this study
Official title: Teriparatide and Risedronate in the Treatment of Patients With Severe Postmenopausal Osteoporosis: Comparative Effects on Vertebral Fractures
The primary purpose of participation in this study is to answer whether teriparatide is superior to risedronate in reducing the occurrence of new vertebral fractures during 24 months of therapy.
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- Teriparatide, Risedronate, Placebo, Calcium, Vitamin D
- Keywords
- Bone Loss, Vertebral fractures
- Medical subject headings
- Osteoporosis, Postmenopausal, Bone Diseases, Metabolic, Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeriparatideDrug
Also called LY333334, Forteo, Forsteo
Administered SC
RisedronateDrug
Administered orally
PlaceboDrug
Teriparatide arm placebo administered orally.
Risedronate arm placebo administered SC.
CalciumDrug
Administered orally
Vitamin DDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Teriparatide | Experimental | Teriparatide 20 microgram (µg) administered by subcutaneous (SC) injection once daily for 24 months.
Placebo given orally once weekly for 24 months.
Elemental Calcium 500 to 1000 milligram per day and Vitamin D 400 to 800 International Units per day, both administered orally once daily while receiving treatment. Receives: Drug: Teriparatide; Drug: Placebo; Drug: Calcium; Drug: Vitamin D |
| Risedronate | Active comparator | Risedronate 35 milligram (mg) administered orally once weekly for 24 months.
Placebo given by SC injection once daily for 24 months.
Elemental Calcium 500 to 1000 milligram per day and Vitamin D 400 to 800 International Units per day, both administered orally once daily while receiving treatment. Receives: Drug: Risedronate; Drug: Placebo; Drug: Calcium; Drug: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With New Vertebral Fractures
The incidence of new vertebral fractures was assessed by quantitative vertebral morphometry measurements (QM) with qualitative visual semiquantitative grading (SQ) confirmation.
A new vertebral fracture was diagnosed in a vertebra that was non-fractured at the baseline radiological examination. It was defined as a loss of vertebral body height of at least 20% and 4 mm from the baseline radiograph by vertebral QM, based upon placement of six points by a trained, central reader. Any fractures identified by QM were confirmed using SQ: if the vertebral body also had an increase of one or more severity grade, it was considered an incident vertebral fracture.
Measured: Baseline through 24 Months
Secondary outcomes (11)
Proportion of Participants With Pooled New and Worsening Vertebral Fractures
Worsening of a pre-existing fracture was considered if the decrease in vertebral height was at least one severity grade in the semi-quantitative assessment, confirmed by a trained central reader, where vertebrae were graded as normal (SQ0) or as with mild (SQ1), moderate (SQ2), or severe (SQ3) fractures, defined as ~20 to 25% (mild), ~25 to 40% (moderate) or ~40% or more (severe) decrease in anterior, central, or posterior vertebral height (T4 to L4).
Measured: Baseline through 24 Months
Proportion of Participants With Pooled Clinical Vertebral and Non-Vertebral Fragility Fractures
A clinical vertebral fracture was defined as a new or worsening vertebral fracture, confirmed by radiography, that was associated with signs and symptoms highly suggestive of a vertebral fracture.
All non-vertebral fractures that occurred and were diagnosed between visits required the confirmation by the site investigators after evaluating the original x-ray film(s), the radiology or surgical report. For clinical vertebral fractures, the final confirmation of the diagnosis required the centralized evaluation by a trained, independent reader.
Measured: Baseline through 24 Months
Proportion of Participants With Non-Vertebral Fragility Fractures
A non-vertebral fracture is a fracture at any of the following non-vertebral sites: clavicle, scapula, ribs, sternum, sacrum, coccyx, humerus, radius, ulna, carpus, pelvis, hip, femur, patella, tibia, fibula, ankle, calcaneus, tarsus, and metatarsal. Non-vertebral fractures were determined by direct questioning at each visit, and confirmed by the site investigators by x-ray, radiology or surgical report. Fractures resulting from a severe trauma such as a traffic collision, a beating, or having been struck by a falling or moving object were not considered fragility fractures but traumatic fractures.
Measured: Baseline through 24 Months
Proportion of Participants With Major Non-Vertebral Fragility Fractures
A major non-vertebral fracture is a fracture at any of the following non-vertebral sites hip, radius, humerus, ribs, pelvis, tibia and femur. Non-vertebral fractures were determined by direct questioning at each visit, and confirmed by the site investigators by x-ray, radiology or surgical report. Fractures resulting from a severe trauma such as a traffic collision, a beating, or having been struck by a falling or moving.
Measured: Baseline through 24 Months
Proportion of Participants With New Moderate and/or Severe Vertebral Fractures
Vertebrae were graded as moderate (SQ2), or severe (SQ3) fractures, based on ~25 to 40% (moderate) or ~40% or more (severe) decrease in anterior, central, or posterior vertebral height (T4 through L4).
Measured: Baseline through 24 Months
Proportion of Participants With New Multiple (2 or More) Vertebral Fractures
Measured: Baseline through 24 Months
Proportion of Participants With Pooled Fragility and Traumatic Non-Vertebral Fractures
Traumatic fractures were considered if resulting from a severe trauma such as a traffic collision, a beating, or having been struck by a falling or moving object.
Measured: Baseline through 24 Months
Change From Baseline to 24 Months Endpoint in Height
Measured: Baseline, 24 Months
Change From Baseline to 24 Months Endpoint in Back Pain Using an 11-point Numerical Pain Rating Scale
Participants rated the worst back pain during the 24 hours preceding the visit at baseline and each post-baseline visit. An 11-point numerical back pain rating scale (rated from 0 = no back pain to 10 = worst possible back pain) was used.
Measured: Baseline, 24 Months
Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (UK)
The EQ-5D-5L is a generic, multidimensional, health-related, quality-of-life instrument completed on five dimensions to measure health-related quality of life. The profile allowed participants to rate their health state in five health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a five level scale (no problems, slight problems, moderate problems, severe problems, and unable to/extreme problems). The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.59 to 1.0. A higher score indicates better health state.
Measured: Baseline, 24 Months
Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (US)
The EQ-5D-5L is a generic, multidimensional, health-related, quality-of-life instrument completed on five dimensions to measure health-related quality of life. The profile allowed participants to rate their health state in five health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a five level scale (no problems, slight problems, moderate problems, severe problems, and unable to/extreme problems). The responses are used to derive the health state index scores using the United States (US) cross walk algorithm, with scores ranging from -0.11 to 1.0. A higher score indicates better health state.
Measured: Baseline, 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionJul 2016
- Study completionJul 2016
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 (5)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal OsteoporosisStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,366 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01709110
- Sponsor's protocol ID
- 14536
- Other IDs
- B3D-EW-GHDW, 2012-000123-41
- Acronym
- VERO
- Status last verified
- Sep 2019
- First submitted
- 16 Oct 2012
- Last updated
- 23 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Publications
Body JJ, Marin F, Kendler DL, Zerbini CAF, Lopez-Romero P, Moricke R, Casado E, Fahrleitner-Pammer A, Stepan JJ, Lespessailles E, Minisola S, Geusens P. Efficacy of teriparatide compared with risedronate on FRAX(R)-defined major osteoporotic fractures: results of the VERO clinical trial. Osteoporos Int. 2020 Oct;31(10):1935-1942. doi: 10.1007/s00198-020-05463-4. Epub 2020 May 30.
PubMed 32474650Geusens P, Kendler DL, Fahrleitner-Pammer A, Lopez-Romero P, Marin F. Distribution of Prevalent and Incident Vertebral Fractures and Their Association with Bone Mineral Density in Postmenopausal Women in the Teriparatide Versus Risedronate VERO Clinical Trial. Calcif Tissue Int. 2020 Jun;106(6):646-654. doi: 10.1007/s00223-020-00683-6. Epub 2020 Mar 10.
PubMed 32157334Minisola S, Marin F, Kendler DL, Geusens P, Zerbini CAF, Russo LA, Casado E, Fahrleitner-Pammer A, Stepan JJ, Lespessailles E, Moericke R, Bagur A, Lakatos P, Lopez-Romero P, Body JJ. Serum 25-hydroxy-vitamin D and the risk of fractures in the teriparatide versus risedronate VERO clinical trial. Arch Osteoporos. 2019 Jan 18;14(1):10. doi: 10.1007/s11657-019-0561-x.
PubMed 30659410Geusens P, Marin F, Kendler DL, Russo LA, Zerbini CA, Minisola S, Body JJ, Lespessailles E, Greenspan SL, Bagur A, Stepan JJ, Lakatos P, Casado E, Moericke R, Lopez-Romero P, Fahrleitner-Pammer A. Effects of Teriparatide Compared with Risedronate on the Risk of Fractures in Subgroups of Postmenopausal Women with Severe Osteoporosis: The VERO Trial. J Bone Miner Res. 2018 May;33(5):783-794. doi: 10.1002/jbmr.3384. Epub 2018 Feb 9.
PubMed 29329484Kendler DL, Marin F, Zerbini CAF, Russo LA, Greenspan SL, Zikan V, Bagur A, Malouf-Sierra J, Lakatos P, Fahrleitner-Pammer A, Lespessailles E, Minisola S, Body JJ, Geusens P, Moricke R, Lopez-Romero P. Effects of teriparatide and risedronate on new fractures in post-menopausal women with severe osteoporosis (VERO): a multicentre, double-blind, double-dummy, randomised controlled trial. Lancet. 2018 Jan 20;391(10117):230-240. doi: 10.1016/S0140-6736(17)32137-2. Epub 2017 Nov 9.
PubMed 29129436
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teriparatide and Risedronate in the Treatment of Patients With Severe Postmenopausal Osteoporosis: Comparative Effects on Vertebral Fractures
- ClinicalTrials.gov ID
- NCT01709110
- Acronym / sponsor ID
- VERO / 14536
- Conditions
- Postmenopausal Osteoporosis
- Keywords
- Bone Loss, Vertebral fractures
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,366 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 17 Oct 2012 (estimated)
- Results
- Posted 23 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of participation in this study is to answer whether teriparatide is superior to risedronate in reducing the occurrence of new vertebral fractures during 24 months of therapy.
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 |
|---|---|---|
| Teriparatide | Experimental | Drug: Teriparatide, Drug: Placebo, Drug: Calcium, Drug: Vitamin DTeriparatide 20 microgram (µg) administered by subcutaneous (SC) injection once daily for 24 months. Placebo given orally once weekly for 24 months. Elemental Calcium 500 to 1000 milligram per day and Vitamin D 400 to 800 International Units per day, both administered orally once daily while receiving treatment. |
| Risedronate | Active comparator | Drug: Risedronate, Drug: Placebo, Drug: Calcium, Drug: Vitamin DRisedronate 35 milligram (mg) administered orally once weekly for 24 months. Placebo given by SC injection once daily for 24 months. Elemental Calcium 500 to 1000 milligram per day and Vitamin D 400 to 800 International Units per day, both administered orally once daily while receiving treatment. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Postmenopausal women with osteoporosis, as defined by low bone mineral density (BMD), i.e. anterior-posterior lumbar spine, total hip or femoral neck BMD ≥1.5 standard deviations below the average BMD for young, healthy, non-Hispanic, Caucasian women
- A minimum of 2 moderate or 1 severe vertebral fragility fractures (confirmed by central reader) were required
Key exclusion criteria (15 listed)
- Increased risk of osteosarcoma
- History of unresolved skeletal diseases that affect bone metabolism
- History of atypical subtrochanteric or diaphyseal femoral fractures
- Abnormally high or low calcium levels
- Abnormally high parathyroid hormone (PTH) levels
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 |
|---|---|---|
| TeriparatideAlso: LY333334, Forteo, ForsteoAdministered SC | Drug | Teriparatide |
| RisedronateAdministered orally | Drug | Risedronate |
| PlaceboTeriparatide arm placebo administered orally. Risedronate arm placebo administered SC. | Drug | Risedronate, Teriparatide |
| CalciumAdministered orally | Drug | Risedronate, Teriparatide |
| Vitamin DAdministered orally | Drug | Risedronate, Teriparatide |
Primary outcome
Proportion of Participants With New Vertebral Fractures
Time frame: Baseline through 24 Months
The incidence of new vertebral fractures was assessed by quantitative vertebral morphometry measurements (QM) with qualitative visual semiquantitative grading (SQ) confirmation. A new vertebral fracture was diagnosed in a vertebra that was non-fractured at the baseline radiological examination. It was defined as a loss of vertebral body height of at least 20% and 4 mm from the baseline radiograph by vertebral QM, based upon placement of six points by a trained, central reader. Any fractures identified by QM were confirmed using SQ: if the vertebral body also had an increase of one or more severity grade, it was considered an incident vertebral fracture.
11 secondary outcomes
Proportion of Participants With Pooled New and Worsening Vertebral Fractures
Time frame: Baseline through 24 Months
Proportion of Participants With Pooled Clinical Vertebral and Non-Vertebral Fragility Fractures
Time frame: Baseline through 24 Months
Proportion of Participants With Non-Vertebral Fragility Fractures
Time frame: Baseline through 24 Months
Proportion of Participants With Major Non-Vertebral Fragility Fractures
Time frame: Baseline through 24 Months
Proportion of Participants With New Moderate and/or Severe Vertebral Fractures
Time frame: Baseline through 24 Months
Proportion of Participants With New Multiple (2 or More) Vertebral Fractures
Time frame: Baseline through 24 Months
Proportion of Participants With Pooled Fragility and Traumatic Non-Vertebral Fractures
Time frame: Baseline through 24 Months
Change From Baseline to 24 Months Endpoint in Height
Time frame: Baseline, 24 Months
Change From Baseline to 24 Months Endpoint in Back Pain Using an 11-point Numerical Pain Rating Scale
Time frame: Baseline, 24 Months
Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (UK)
Time frame: Baseline, 24 Months
Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (US)
Time frame: Baseline, 24 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32474650Body JJ, Marin F, Kendler DL, Zerbini CAF, Lopez-Romero P, Moricke R, Casado E, Fahrleitner-Pammer A, Stepan JJ, Lespessailles E, Minisola S, Geusens P. Efficacy of teriparatide compared with risedronate on FRAX(R)-defined major osteoporotic fractures: results of the VERO clinical trial. Osteoporos Int. 2020 Oct;31(10):1935-1942. doi: 10.1007/s00198-020-05463-4. Epub 2020 May 30.
- Derived from this study: PubMed 32157334Geusens P, Kendler DL, Fahrleitner-Pammer A, Lopez-Romero P, Marin F. Distribution of Prevalent and Incident Vertebral Fractures and Their Association with Bone Mineral Density in Postmenopausal Women in the Teriparatide Versus Risedronate VERO Clinical Trial. Calcif Tissue Int. 2020 Jun;106(6):646-654. doi: 10.1007/s00223-020-00683-6. Epub 2020 Mar 10.
- Derived from this study: PubMed 30659410Minisola S, Marin F, Kendler DL, Geusens P, Zerbini CAF, Russo LA, Casado E, Fahrleitner-Pammer A, Stepan JJ, Lespessailles E, Moericke R, Bagur A, Lakatos P, Lopez-Romero P, Body JJ. Serum 25-hydroxy-vitamin D and the risk of fractures in the teriparatide versus risedronate VERO clinical trial. Arch Osteoporos. 2019 Jan 18;14(1):10. doi: 10.1007/s11657-019-0561-x.
- Derived from this study: PubMed 29329484Geusens P, Marin F, Kendler DL, Russo LA, Zerbini CA, Minisola S, Body JJ, Lespessailles E, Greenspan SL, Bagur A, Stepan JJ, Lakatos P, Casado E, Moericke R, Lopez-Romero P, Fahrleitner-Pammer A. Effects of Teriparatide Compared with Risedronate on the Risk of Fractures in Subgroups of Postmenopausal Women with Severe Osteoporosis: The VERO Trial. J Bone Miner Res. 2018 May;33(5):783-794. doi: 10.1002/jbmr.3384. Epub 2018 Feb 9.
- Derived from this study: PubMed 29129436Kendler DL, Marin F, Zerbini CAF, Russo LA, Greenspan SL, Zikan V, Bagur A, Malouf-Sierra J, Lakatos P, Fahrleitner-Pammer A, Lespessailles E, Minisola S, Body JJ, Geusens P, Moricke R, Lopez-Romero P. Effects of teriparatide and risedronate on new fractures in post-menopausal women with severe osteoporosis (VERO): a multicentre, double-blind, double-dummy, randomised controlled trial. Lancet. 2018 Jan 20;391(10117):230-240. doi: 10.1016/S0140-6736(17)32137-2. Epub 2017 Nov 9.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
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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.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
103 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Teriparatide, Risedronate and Calcium in people with Postmenopausal Osteoporosis, run by Eli Lilly and Company at 103 sites in 15 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 2 inclusion and 15 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 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 103 sites in United States, Belgium, Canada, Italy, France and 10 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 23 Jan 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?
Proportion of Participants With New Vertebral Fractures (time frame: Baseline through 24 Months). 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 NCT01709110, which also lists 5 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 23 Sep 2019.