Trial Information

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

Status: Completed

Protocol Number: BA18492

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: Double-blind,placebo-controlled,randomized, multicenter study to assess the efficiency and safety of oral ibandronate 150 mg once monthly in postmenopausal women with osteopenia

Brief Summary: This 2 arm study will evaluate the efficacy and safety of oral Bonviva 150mg once monthly compared with placebo in post-menopausal women with osteopenia. Patients will be randomized to receive either Bonviva 150mg po monthly, or placebo monthly. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals. Target sample size is 160.

Study Phase: IV

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. Relative change in mean lumbar spine bone mineral density (BMD) Time frame: 12 months

Key Secondary Outcomes: 1. Absolute change in mean lumbar spine BMD Time frame: 12 months 2. Relative and absolute change in mean proximal femur BMD Time frame: 12 months 3. Percentage of responders Time frame: 12 months 4. Relative and absolute change in serum CTX Time frame: 12 months 5. AEs and laboratory parameters Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Females

Age Limits: Min: 45 Years Max: 60 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 10/21/2005

Date Last Updated: 09/19/2008

Link To Trial Results

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Trial listings updated: October 6, 2008 at 2:58:05 PM