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A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia.

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00545207
First received: October 16, 2007
Last updated: January 18, 2011
Last verified: December 2010
History of Changes
  Purpose

This 2 arm study will compare the effect of oral Bonviva (150mg, monthly) and placebo on parameters of bone micro-architecture, assessed by CT scan, bone turnover and bone mineral density. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, and measurements will be taken at baseline, and at intervals over 2 years. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.


Condition Intervention Phase
Post-Menopausal Osteopenia
 Drug: ibandronate [Bonviva/Boniva]
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind Study of the Effect of Oral Monthly Bonviva on in Vivo Bone Micro-architecture Parameters in Post-menopausal Women With Osteopenia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Trabecular BV/TV at distal radius of non-dominant arm [ Time Frame: 12 arms ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Trabecular BV/TV at distal radius of non-dominant arm [ Time Frame: 6 months and 2 years ] [ Designated as safety issue: No ]
  • Bone density, trabecular BV/TV at distal tibia [ Time Frame: 6 months, 1 and 2 years ] [ Designated as safety issue: No ]
  • Serum CTX [ Time Frame: Intervals throughout study ] [ Designated as safety issue: No ]
  • Lumbar hip and wrist BMD [ Time Frame: 1 and 2 years ] [ Designated as safety issue: No ]
  • AEs and laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 150
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: ibandronate [Bonviva/Boniva]
150mg po monthly for 2 years
Placebo Comparator: 2 Drug: Placebo
po monthly for 2 years

  Eligibility

Ages Eligible for Study:   55 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • post-menopausal women, aged 55-75 years;
  • diagnosed osteopenia.

Exclusion Criteria:

  • history of osteoporotic vertebral fracture;
  • contraindication to ibandronate.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545207

Locations
France
Lyon, France, 69437
Paris, France, 75475
Saint-priest En Jarez, France, 42277
Toulouse, France, 31059
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00545207     History of Changes
Other Study ID Numbers: ML19357
Study First Received: October 16, 2007
Last Updated: January 18, 2011
Health Authority: France: Agence francaise de securite sanitaire des produits de sante (AFSSAPS)

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Ibandronic acid
 Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013