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: 09/19/2008

Link To Trial Results

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Trial listings updated: October 6, 2008 at 2:56:26 PM