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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00545207
Recruitment Status : Completed
First Posted : October 17, 2007
Last Update Posted : January 26, 2017
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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 or disease Intervention/treatment Phase
Post-Menopausal Osteopenia Drug: ibandronate [Bonviva/Boniva] Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
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
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

Arm Intervention/treatment
Experimental: 1 Drug: ibandronate [Bonviva/Boniva]
150mg po monthly for 2 years

Placebo Comparator: 2 Drug: Placebo
po monthly for 2 years

Primary Outcome Measures :
  1. Trabecular BV/TV at distal radius of non-dominant arm [ Time Frame: 12 arms ]

Secondary Outcome Measures :
  1. Trabecular BV/TV at distal radius of non-dominant arm [ Time Frame: 6 months and 2 years ]
  2. Bone density, trabecular BV/TV at distal tibia [ Time Frame: 6 months, 1 and 2 years ]
  3. Serum CTX [ Time Frame: Intervals throughout study ]
  4. Lumbar hip and wrist BMD [ Time Frame: 1 and 2 years ]
  5. AEs and laboratory parameters [ Time Frame: Throughout study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00545207

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Lyon, France, 69437
Paris, France, 75475
Saint-priest En Jarez, France, 42277
Toulouse, France, 31059
Sponsors and Collaborators
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche Identifier: NCT00545207    
Other Study ID Numbers: ML19357
First Posted: October 17, 2007    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Ibandronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs