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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

October 16, 2007
January 18, 2011
Not Provided
September 2010   (final data collection date for primary outcome measure)
Trabecular BV/TV at distal radius of non-dominant arm [ Time Frame: 12 arms ] [ Designated as safety issue: No ]
Trabecular BV/TV at distal radius of non-dominant arm at 1 year.
Complete list of historical versions of study NCT00545207 on ClinicalTrials.gov Archive Site
  • 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 ]
Efficacy: Trabecular BV/TV at distal radius of non-dominant arm at 6 months and 2 years; bone density, trabecular BV/TV at distal tibia at 6 months, 1 and 2 years; serum CTX; lumbar, hip and wrist BMD at 1 and 2 years. Safety: AEs and laboratory tests.
Not Provided
Not Provided
 
A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia.
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

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Post-Menopausal Osteopenia
  • Drug: ibandronate [Bonviva/Boniva]
    150mg po monthly for 2 years
  • Drug: Placebo
    po monthly for 2 years
  • Experimental: 1
    Intervention: Drug: ibandronate [Bonviva/Boniva]
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
September 2010
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • history of osteoporotic vertebral fracture;
  • contraindication to ibandronate.
Female
55 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00545207
ML19357
Not Provided
Disclosures Group, Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP