Trial Information

Summary: A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Previously Treated With Bonviva

Status: Completed

Protocol Number: MA17903

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: Double-blind, partially randomized, parallel group, multicenter study to assess the efficacy and safety of 100 mg and 150 mg monthly oral ibandronate in women with postmenopausal osteoporosis having completed the phase III oral ibandronate trial BM16549

Brief Summary: This 2 arm study will assess the long-term efficacy and safety of oral treatment with 100mg or 150mg Bonviva in women with post-menopausal osteoporosis who have previously completed Bonviva study BM16549 (MOBILE study). Patients will receive Bonviva either 100mg po monthly, or 150mg po monthly. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals. Target sample size is 719.

Study Phase: IV

Study Design / Study Details:

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

Study Type:

Condition: Post-Menopausal Osteoporosis

Intervention Type: Drug

Intervention Name: ibandronate [Bonviva/Boniva]

Primary Outcome: 1. Relative change in mean lumbar spine bone mineral density (BMD) Time frame: 12, 24 and 36 months

Key Secondary Outcomes: 1. Relative change in mean total hip BMD Time frame: 12, 24 and 36 months 2. Relative change in serum CTX Time frame: Trough and peak suppression 3. AEs and laboratory parameters Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Females

Age Limits: Min: Years

Accepts Healthy Volunteers: No

Trial Registration Date: 06/24/2005

Date Last Updated: 09/19/2008

Link To Trial Results

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Trial listings updated: October 6, 2008 at 2:47:34 PM