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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: October 16, 2007
Last updated: January 25, 2017
Last verified: January 2017
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:

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 ]

Secondary Outcome Measures:
  • 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 ]

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


Ages Eligible for Study:   55 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • history of osteoporotic vertebral fracture;
  • contraindication to ibandronate.
  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 identifier: NCT00545207

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

Responsible Party: Hoffmann-La Roche Identifier: NCT00545207     History of Changes
Other Study ID Numbers: ML19357
Study First Received: October 16, 2007
Last Updated: January 25, 2017

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Ibandronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs processed this record on September 20, 2017