Trial Information

Summary: PRIOR Study - A Study of Boniva (Ibandronate) in Postmenopausal Women With Osteoporosis or Osteopenia

Status: Completed

Protocol Number: ML18058

Sponsor: Roche Laboratories Inc.

Company Division: Pharmaceutical

Official Scientific Title: An open-label study of level of treatment adherence to monthly oral or every 3-month intravenous Bonviva in women with post-menopausal osteoporosis who are intolerant to daily or weekly alendronate or risendronate therapy

Brief Summary: The purpose of this study is to evaluate treatment adherence to different regimens of Bonviva in postmenopausal women with osteoporosis or osteopenia who are intolerant to daily or weekly alendronate or risedronate therapy due to gastrointestinal (GI) side effects. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals. Target sample size is 515.

Study Phase: IV

Study Design / Study Details:

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

Study Type:

Condition: Post-Menopausal Osteoporosis

Intervention Type: Drug

Intervention Name: ibandronate[Bonviva/Boniva]

Primary Outcome: 1. Proportion of patients who have >=75% adherence using either monthly oral Bonviva or quarterly IV Bonviva

Key Secondary Outcomes: 1. Severity and frequency of GI events, and proportion of patients who have a change in pattern of GI events, at screening and months 3 and 10; Safety: adverse events, laboratory tests

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 2:57:17 PM