Trial Information

Summary: A Study of Boniva (Ibandronate) to Evaluate Bone Turnover Markers in Women With Treatment-Naive Post-Menopausal Osteoporosis

Status: Completed

Protocol Number: ML18057

Sponsor: Roche Laboratories Inc.

Company Division: Pharmaceutical

Official Scientific Title: A prospective open-label study to evaluate the change in bone turnover markers, and the effect of an early response on predictivity of response, after once-monthly oral Boniva therapy in treatment-naive postmenopausal osteoporosis patients

Brief Summary: This study will evaluate whether an early positive response to once-monthly oral Bonviva in treatment-naive patients with post-menopausal osteoporosis is predictive of efficacy later in treatment. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 389.

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. Percent change from baseline at 6 months by measurement of serum CTX and other bone turnover markers

Key Secondary Outcomes: 1. Absolute change from baseline to 6 months in bone turnover markers; confidence intervals of relative mean BMD changes; adverse events, including fractures; safety laboratory blood tests; patient confidence level

Inclusion Criteria:

Exclusion Criteria:

Gender: Females

Age Limits: Min: Years

Accepts Healthy Volunteers: No

Trial Registration Date: 08/30/2005

Date Last Updated: 09/19/2008

Link To Trial Results

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Trial listings updated: October 6, 2008 at 2:56:46 PM