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

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Post-Menopausal Osteopenia

Intervention: ibandronate [Bonviva/Boniva] (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Trabecular BV/TV at distal radius of non-dominant arm

Secondary outcome:

Trabecular BV/TV at distal radius of non-dominant arm

Bone density, trabecular BV/TV at distal tibia

Serum CTX

Lumbar hip and wrist BMD

AEs and laboratory parameters

Eligibility

Minimum age: 55 Years. Maximum age: 75 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- post-menopausal women, aged 55-75 years;

- diagnosed osteopenia.

Exclusion Criteria:

- history of osteoporotic vertebral fracture;

- contraindication to ibandronate.

Locations and Contacts

Lyon 69437, France

Paris 75475, France

Saint-priest En Jarez 42277, France

Toulouse 31059, France

Additional Information


Last updated: January 18, 2011

Page last updated: August 23, 2015

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