Trial Information

Summary: A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Who Have Received Previous Bonviva Treatment

Status: No longer recruiting

Protocol Number: MA17904

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: Open label, parallel group, multicenter study of two IV ibandronate dose regimens (2 mg every 2 months and 3 mg every 3 months) in women with postmenopausal osteoporosis who completed trial BM16550

Brief Summary: This 2 arm study will assess the long-term safety and tolerability of intravenous treatment with 2mg or 3mg Bonviva in women with post-menopausal osteoporosis who have previously completed Bonviva study BM16550 (DIVA study). Patients will receive Bonviva either 2mg iv every 2 months, or 3mg iv every 3 months 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 650.

Study Phase: IV

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Non-Randomized
• Masking: Open Label
• Control: Uncontrolled
• 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

Anticipated Start Date: October, 2004

Trial Registration Date: 06/24/2005

Date Last Updated: 04/16/2008

Link To Trial Results

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Trial listings updated: May 13, 2008 at 1:58:56 PM