Trial Information

Summary: A Study of Boniva (Ibandronate) to Evaluate Satisfaction in Women With Post-Menopausal Osteoporosis or Osteopenia

Status: Completed

Protocol Number: ML18056

Sponsor: Roche Laboratories Inc.

Company Division: Pharmaceutical

Official Scientific Title: A prospective, open-label, two-part study of treatment satisfaction with monthly oral Boniva in women with post-menopausal osteoporosis transitioned from weekly alendronate or risendronate

Brief Summary: This study will investigate patient satisfaction (including compliance, preference, tolerability) with once-monthly Bonviva in women with post-menopausal osteoporosis or osteopenia transitioned from once-weekly alendronate or risedronate. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals. Target sample size is 1776.

Study Phase: IV

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Non-Randomized
• Masking: Open Label
• Control: Uncontrolled
• Assignment: Single Group
• Endpoints: Safety

Study Type:

Condition: Post-Menopausal Osteoporosis

Intervention Type: Drug

Intervention Name: ibandronate[Bonviva/Boniva]

Primary Outcome: 1. Patient satisfaction; number and proportion of patients who show improvement from baseline satisfaction score after 6 months of Bonviva

Key Secondary Outcomes: 1. Evaluation of sub-groups (no. and %) with respect to willingness to enter part B, improved satisfaction, dosing schedule preference, compliance, receiving a reminder, GI symptoms, etc

Inclusion Criteria:

Exclusion Criteria:

Gender: Females

Age Limits: Min: Years

Accepts Healthy Volunteers: No

Trial Registration Date: 08/30/2005

Date Last Updated: 08/18/2008

Link To Trial Results

This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials.

Trial listings updated: August 20, 2008 at 2:20:35 PM