Trial Information

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

Status: No longer recruiting

Protocol Number: ML19357

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific 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

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. Target sample size is 150.

Study Phase: III

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Double Blind
• Control: Placebo
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

Condition: Post-Menopausal Osteopenia

Intervention Type: Drug

Intervention Name: ibandronate [Bonviva/Boniva]

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

Key Secondary Outcomes: 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

Inclusion Criteria:

Exclusion Criteria:

Gender: Females

Age Limits: Min: 55 Years Max: 75 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: January, 2007

Trial Registration Date: 07/19/2006

Date Last Updated: 08/18/2008

Link To Trial Results

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Trial listings updated: September 2, 2008 at 2:14:26 PM