VERtebral Fracture Treatment Comparisons in Osteoporotic Women
NCT ID: NCT01709110
Last Updated: 2019-09-23
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
1366 participants
Study Classification
INTERVENTIONAL
Study Start Date
2012-10-31
Study Completion Date
2016-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Postmenopausal Osteoporosis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Teriparatide
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.
Group Type
EXPERIMENTAL
Teriparatide
Intervention Type
DRUG
Administered SC
Placebo
Intervention Type
DRUG
Teriparatide arm placebo administered orally.
Risedronate arm placebo administered SC.
Calcium
Intervention Type
DRUG
Administered orally
Vitamin D
Intervention Type
DRUG
Administered orally
Risedronate
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.
Group Type
ACTIVE_COMPARATOR
Risedronate
Intervention Type
DRUG
Administered orally
Placebo
Intervention Type
DRUG
Teriparatide arm placebo administered orally.
Risedronate arm placebo administered SC.
Calcium
Intervention Type
DRUG
Administered orally
Vitamin D
Intervention Type
DRUG
Administered orally
Interventions
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Teriparatide
Administered SC
Intervention Type
DRUG
Risedronate
Administered orally
Intervention Type
DRUG
Placebo
Teriparatide arm placebo administered orally.
Risedronate arm placebo administered SC.
Intervention Type
DRUG
Calcium
Administered orally
Intervention Type
DRUG
Vitamin D
Administered orally
Intervention Type
DRUG
Other Intervention Names
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LY333334
Forteo
Forsteo
Eligibility Criteria
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Inclusion Criteria
* 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
* A minimum of 2 moderate or 1 severe vertebral fragility fractures (confirmed by central reader) were required
Exclusion Criteria
* 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
* 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
* 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
* 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
Minimum Eligible Age
45 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Orléans, , France
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Saint-Etienne, , France
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Toulouse, , France
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Dresden, , Germany
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Frankfurt, , Germany
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Hamburg, , Germany
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Leipzig, , Germany
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Magdeburg, , Germany
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Athens, , Greece
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Kifissia, , Greece
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Pátrai, , Greece
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Thessaloniki, , Greece
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Budapest, , Hungary
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Debrecen, , Hungary
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Eger, , Hungary
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Kaposvár, , Hungary
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Szeged, , Hungary
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Florence, , Italy
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Genova-Nervi, , Italy
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Orbassano, , Italy
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Padua, , Italy
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Rome, , Italy
Site Status
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Torino, , Italy
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Valeggio sul Mincio, , Italy
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Bialystok, , Poland
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Elblag, , Poland
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Lublin, , Poland
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Poznan, , Poland
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Świdnik, , Poland
Site Status
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Warsaw, , Poland
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San Juan, , Puerto Rico
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Alzira, , Spain
Site Status
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Barcelona, , Spain
Site Status
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Cadiz, , Spain
Site Status
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Madrid, , Spain
Site Status
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Sabadell, , Spain
Site Status
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Valencia, , Spain
Site Status
Countries
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United States
Argentina
Austria
Belgium
Brazil
Canada
Czechia
France
Germany
Greece
Hungary
Italy
Poland
Puerto Rico
Spain
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
DERIVED
Geusens 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.
Reference Type
DERIVED
Minisola 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.
Reference Type
DERIVED
Geusens 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.
Reference Type
DERIVED
Kendler 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.
Reference Type
DERIVED
Other Identifiers
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B3D-EW-GHDW
Identifier Type: OTHER
Identifier Source: secondary_id
2012-000123-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
14536
Identifier Type: -
Identifier Source: org_study_id
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