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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 (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00545207
First received: October 16, 2007
Last updated: January 25, 2017
Last verified: January 2017
History of Changes
October 16, 2007
January 25, 2017
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 ]
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 ]
  • Bone density, trabecular BV/TV at distal tibia [ Time Frame: 6 months, 1 and 2 years ]
  • Serum CTX [ Time Frame: Intervals throughout study ]
  • Lumbar hip and wrist BMD [ Time Frame: 1 and 2 years ]
  • AEs and laboratory parameters [ Time Frame: Throughout study ]
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Sexes Eligible for Study: Female
55 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00545207
ML19357
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
January 2017

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