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VERtebral Fracture Treatment Comparisons in Osteoporotic Women (VERO)

This study is currently recruiting participants.
Verified June 2013 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01709110
First received: October 16, 2012
Last updated: June 14, 2013
Last verified: June 2013
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of Participants with Pooled New and Worsening Vertebral Fractures [ Time Frame: Baseline through 24 Months ] [ Designated as safety issue: No ]
  • Proportion of Participants with Pooled Clinical Vertebral and Non-Vertebral Fragility Fractures [ Time Frame: Baseline through 24 Months ] [ Designated as safety issue: No ]
  • Proportion of Participants with Non-Vertebral Fragility Fractures [ Time Frame: Baseline through 24 Months ] [ Designated as safety issue: No ]
  • Proportion of Participants with Major Non-Vertebral Fragility Fractures [ Time Frame: Baseline through 24 Months ] [ Designated as safety issue: No ]
  • Proportion of Participants with New Moderate and/or Severe Vertebral Fractures [ Time Frame: Baseline through 24 Months ] [ Designated as safety issue: No ]
  • Proportion of Participants with New Multiple (2 or more) Vertebral Fractures [ Time Frame: Baseline through 24 Months ] [ Designated as safety issue: No ]
  • Proportion of Participants with Pooled Fragility and Traumatic Non-Vertebral Fractures [ Time Frame: Baseline through 24 Months ] [ Designated as safety issue: No ]
  • Change from Baseline to 24 Months Endpoint in Height [ Time Frame: Baseline, 24 Months ] [ Designated as safety issue: No ]
  • Change from Baseline to 24 Month Endpoint in Back Pain using an 11-point Numerical Pain Rating Scale [ Time Frame: Baseline, 24 Months ] [ Designated as safety issue: No ]
  • Change from Baseline to 24 Month Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] [ Time Frame: Baseline, 24 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1340
Study Start Date: October 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 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
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01709110

Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

  Show 101 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

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01709110     History of Changes
Other Study ID Numbers: 14536, B3D-EW-GHDW, 2012-000123-41
Study First Received: October 16, 2012
Last Updated: June 14, 2013
Health Authority: United States: Food and Drug Administration
Austria: Federal Office for Safety in Health Care
Germany: Federal Institute for Drugs and Medical Devices
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Italy: Ministry of Health
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
Greece: National Organization of Medicines
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: National Health Surveillance Agency
Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on June 17, 2013