Clinical trial NCT01709110: VERtebral Fracture Treatment Comparisons in Osteoporotic Women
Official title: Teriparatide and Risedronate in the Treatment of Patients With Severe Postmenopausal Osteoporosis: Comparative Effects on Vertebral Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postmenopausal Osteoporosis
Keywords: Bone Loss
Vertebral fractures
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2012-10-17
Enrollment: 1366
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

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

Primary outcomes:
measure: Proportion of Participants With New Vertebral Fractures
timeFrame: Baseline through 24 Months
Secondary outcomes:
measure: Proportion of Participants With Pooled New and Worsening Vertebral Fractures
timeFrame: Baseline through 24 Months
measure: Proportion of Participants With Pooled Clinical Vertebral and Non-Vertebral Fragility Fractures
timeFrame: Baseline through 24 Months
measure: Proportion of Participants With Non-Vertebral Fragility Fractures
timeFrame: Baseline through 24 Months
measure: Proportion of Participants With Major Non-Vertebral Fragility Fractures
timeFrame: Baseline through 24 Months
measure: Proportion of Participants With New Moderate and/or Severe Vertebral Fractures
timeFrame: Baseline through 24 Months
measure: Proportion of Participants With New Multiple (2 or More) Vertebral Fractures
timeFrame: Baseline through 24 Months
measure: Proportion of Participants With Pooled Fragility and Traumatic Non-Vertebral Fractures
timeFrame: Baseline through 24 Months
measure: Change From Baseline to 24 Months Endpoint in Height
timeFrame: Baseline, 24 Months
measure: Change From Baseline to 24 Months Endpoint in Back Pain Using an 11-point Numerical Pain Rating Scale
timeFrame: Baseline, 24 Months
measure: Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (UK)
timeFrame: Baseline, 24 Months
measure: Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (US)
timeFrame: Baseline, 24 Months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 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.
state: Alabama
city: Concord
country: United States
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state: California
city: Fresno
country: United States
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state: California
city: Laguna Hills
country: United States
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state: California
city: Lancaster
country: United States
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state: California
city: Tustin
country: United States
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state: California
city: Lakewood
country: United States
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state: Colorado
city: Danbury
country: United States
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state: Connecticut
city: Orlando
country: United States
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state: Florida
city: Gainesville
country: United States
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state: Georgia
city: Evansville
country: United States
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state: Indiana
city: Indianapolis
country: United States
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state: Indiana
city: Topeka
country: United States
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state: Kansas
city: Bethesda
country: United States
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state: Maryland
city: Detroit
country: United States
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state: Michigan
city: Omaha
country: United States
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state: Nebraska
city: Clifton
country: United States
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state: New Jersey
city: Freehold
country: United States
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state: New Jersey
city: Albuquerque
country: United States
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state: New Mexico
city: Asheville
country: United States
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state: North Carolina
city: Greensboro
country: United States
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state: North Carolina
city: Fargo
country: United States
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state: North Dakota
city: Bend
country: United States
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state: Oregon
city: Duncansville
country: United States
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state: Pennsylvania
city: Pittsburgh
country: United States
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state: Pennsylvania
city: Wyomissing
country: United States
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state: Pennsylvania
city: Dallas
country: United States
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state: Texas
city: Seattle
country: United States
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state: Washington
city: Spokane
country: United States
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state: Washington
city: Madison
country: United States
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state: Wisconsin
city: Buenos Aires
country: Argentina
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city: Caba
country: Argentina
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city: Mar Del Plata
country: Argentina
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city: Graz
country: Austria
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city: Hohenems
country: Austria
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city: Linz
country: Austria
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city: Vienna
country: Austria
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city: Brussels
country: Belgium
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city: Genk
country: Belgium
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city: Gent
country: Belgium
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city: Gilly
country: Belgium
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city: Laken
country: Belgium
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city: Leuven
country: Belgium
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city: Liège
country: Belgium
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city: Merksem
country: Belgium
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city: Mons
country: Belgium
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city: Brasilia
country: Brazil
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city: Rio De Janeiro
country: Brazil
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city: São Paulo
country: Brazil
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city: Kelowna
country: Canada
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state: British Columbia
city: Vancouver
country: Canada
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state: British Columbia
city: Halifax
country: Canada
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state: Nova Scotia
city: Hamilton
country: Canada
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state: Ontario
city: Toronto
country: Canada
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state: Ontario
city: Montreal
country: Canada
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state: Quebec
city: Sainte-Foy
country: Canada
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state: Quebec
city: Trois-Rivieres
country: Canada
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state: Quebec
city: Saskatoon
country: Canada
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state: Saskatchewan
city: Ceske Budejovice
country: Czechia
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city: Klatovy
country: Czechia
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city: Prague
country: Czechia
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city: Uherske Hradiste
country: Czechia
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city: Caen
country: France
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city: La Crau
country: France
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city: Lyon
country: France
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city: Orleans
country: France
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city: Saint-Etienne
country: France
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city: Toulouse
country: France
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city: Dresden
country: Germany
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city: Frankfurt
country: Germany
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city: Hamburg
country: Germany
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city: Leipzig
country: Germany
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city: Magdeburg
country: Germany
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city: Marburg
country: Germany
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city: Athens
country: Greece
facility: 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.
city: Kifissia
country: Greece
facility: 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.
city: Patras
country: Greece
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city: Thessaloniki
country: Greece
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city: Budapest
country: Hungary
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city: Debrecen
country: Hungary
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city: Eger
country: Hungary
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city: Kaposvar
country: Hungary
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city: Szeged
country: Hungary
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city: Firenze
country: Italy
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city: Genova-Nervi
country: Italy
facility: 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.
city: Orbassano
country: Italy
facility: 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.
city: Padova
country: Italy
facility: 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.
city: Rome
country: Italy
facility: 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.
city: Torino
country: Italy
facility: 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.
city: Valeggio Sul Mincio
country: Italy
facility: 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.
city: Bialystok
country: Poland
facility: 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.
city: Elblag
country: Poland
facility: 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.
city: Lublin
country: Poland
facility: 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.
city: Poznan
country: Poland
facility: 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.
city: Swidnik
country: Poland
facility: 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.
city: Warsaw
country: Poland
facility: 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.
city: San Juan
country: Puerto Rico
facility: 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.
city: Alcira
country: Spain
facility: 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.
city: Barcelona
country: Spain
facility: 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.
city: Cadiz
country: Spain
facility: 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.
city: Madrid
country: Spain
facility: 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.
city: Sabadell
country: Spain
facility: 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.
city: Valencia
country: Spain
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.