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

Condition(s) targeted: Post-Menopausal Osteopenia

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

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche, +1 973 235 5000

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.

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: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

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.

LYON 69000, France

TOULOUSE 31059, France

SAINT-ETIENNE 4200, France

PARIS 75010, France

Starting date: January 2007
Ending date: March 2010
Last updated: June 17, 2008