Trial Information

Summary: BONCURE Study: A Study of Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis on Bisphosphonate Therapy.

Status: No longer recruiting

Protocol Number: ML20430

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: 'An open-label study of patient preference with monthly Bonviva therapy in women with post-menopausal osteoporosis switched from daily or weekly alendronate or risendronate.'

Brief Summary: This single arm study will assess patient preference for monthly Bonviva, versus daily or weekly alendronate or risedronate, in the treatment of postmenopausal osteoporosis. Patients currently on a daily or weekly regimen of bisphosphonate therapy (alendronate or risedronate) will answer a questionnaire to identify patients who may benefit from a monthly Bonviva regimen. Eligible patients will then discontinue their present bisphosphonate treatment, and switch to monthly Bonviva 150mg po. At the beginning and end of Bonviva treatment, all patients will complete an Osteoporosis Patient Satisfaction Questionnaire. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals. Target sample size is 650.

Study Phase: IV

Study Design / Study Details:

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

Study Type:

Condition: Post-Menopausal Osteoporosis

Intervention Type: Drug

Intervention Name: ibandronate [Bonviva/Boniva]

Primary Outcome: 1. Number and percentage of patients who prefer monthly Bonviva, compared with previous daily or weekly alendronate or risedronate Time frame: 6 months

Key Secondary Outcomes: 1. Improved satisfaction scores with Bonviva Time frame: 6 months 2. >=80% compliance with Bonviva Time frame: 6 months 3. Choice of monthly reminders to take Bonviva Time frame: 6 months 4. Improvement in GI symptoms Time frame: 6 months

Inclusion Criteria:

Exclusion Criteria:

Gender: Females

Age Limits: Min: Years

Accepts Healthy Volunteers: No

Anticipated Start Date: December, 2006

Trial Registration Date: 10/17/2006

Date Last Updated: 04/16/2008

Link To Trial Results

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Trial listings updated: May 13, 2008 at 2:36:17 PM