Trial Information

Summary: A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis.

Status: No longer recruiting

Protocol Number: MA19547

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: Randomized, open-label, multi-center study to investigate patient preference on dosing in women with postmenopausal osteoporosis treated with once monthly ibandronate and once weekly risedronate. A six month, two-sequence and two-period crossover study.

Brief Summary: This 2 arm crossover study will evaluate patient reported preference for either once monthly Boniva (150mg p.o.) or once weekly risedronate (35mg p.o.). Patients with post-menopausal osteoporosis will be randomized to receive Boniva for 3 calendar months or risedronate for 12 weeks; they will then cross over to receive the alternative treatment for a further 12 weeks/3 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 356.

Study Phase: IV

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Open Label
• Control: Active
• Assignment: Crossover
• Endpoints: Safety/Efficacy

Study Type:

Condition: Post-Menopausal Osteoporosis

Intervention Type: Drug

Intervention Name: ibandronate [Bonviva/Boniva]

Primary Outcome: 1. Proportion of patients preferring monthly dosing with Bonviva over weekly dosing with risedronate Time frame: 6 months

Key Secondary Outcomes: 1. Convenience of monthly Bonviva over weekly risedronate Time frame: 6 months 2. Change in serum CTX Time frame: 12 weeks/3 months 3. Upper gastrointestinal symptoms Time frame: 12 weeks/3 months 4. AEs and laboratory parameters Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Females

Age Limits: Min: 55 Years Max: 80 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: May, 2006

Trial Registration Date: 09/18/2006

Date Last Updated: 08/18/2008

Link To Trial Results

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Trial listings updated: September 2, 2008 at 2:13:36 PM