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VERtebral Fracture Treatment Comparisons in Osteoporotic Women (VERO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01709110
First received: October 16, 2012
Last updated: July 14, 2016
Last verified: July 2016
  Purpose
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.

Condition Intervention Phase
Postmenopausal Osteoporosis
Drug: Teriparatide
Drug: Risedronate
Drug: Placebo
Drug: Calcium
Drug: Vitamin D
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Teriparatide and Risedronate in the Treatment of Patients With Severe Postmenopausal Osteoporosis: Comparative Effects on Vertebral Fractures

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Proportion of Participants with New Vertebral Fractures [ Time Frame: Baseline through 24 Months ]

Secondary Outcome Measures:
  • 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 Month Endpoint in Back Pain using an 11-point Numerical Pain Rating Scale [ Time Frame: Baseline, 24 Months ]
  • Change from Baseline to 24 Month Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] [ Time Frame: Baseline, 24 Months ]

Enrollment: 1327
Study Start Date: October 2012
Study Completion Date: July 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

Drug: Teriparatide
Administered SC
Other Names:
  • LY333334
  • Forteo
  • Forsteo
Drug: Placebo

Teriparatide arm placebo administered orally.

Risedronate arm placebo administered SC.

Drug: Calcium
Administered orally
Drug: Vitamin D
Administered orally
Active Comparator: 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.

Drug: Risedronate
Administered orally
Drug: Placebo

Teriparatide arm placebo administered orally.

Risedronate arm placebo administered SC.

Drug: Calcium
Administered orally
Drug: Vitamin D
Administered orally

  Eligibility

Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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) are 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01709110

  Show 103 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01709110     History of Changes
Other Study ID Numbers: 14536
B3D-EW-GHDW ( Other Identifier: Eli Lilly and Company )
2012-000123-41 ( EudraCT Number )
Study First Received: October 16, 2012
Last Updated: July 14, 2016

Keywords provided by Eli Lilly and Company:
Bone Loss
Vertebral fractures

Additional relevant MeSH terms:
Osteoporosis
Spinal Fractures
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Spinal Injuries
Back Injuries
Wounds and Injuries
Fractures, Bone
Vitamins
Vitamin D
Ergocalciferols
Calcium, Dietary
Teriparatide
Risedronate Sodium
Etidronic Acid
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 25, 2017