Trial Information

Summary: A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis

Status: Completed

Protocol Number: MM17385

Sponsor: Hoffman-La Roche

Company Division: Pharmaceutical

Official Scientific Title: Randomized, double-blind, double-dummy, parallel group, multicenter study to compare the efficacy and safety of once-monthly oral administration of 150mg ibandronate with once-weekly oral administration of 70mg alendronate in postmenopausal osteoporosis - Non-inferiority trial.

Brief Summary: This study will evaluate the safety and efficacy of oral Bonviva and that of oral alendronate in women with post-menopausal osteoporosis. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals. Target sample size is 1786.

Study Phase: III

Study Design / Study Details:

  • Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double Blind
  • Control: Active
  • Assignment: Parallel
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

Condition: Post-Menopausal Osteoporosis

Intervention Type: Drug

Intervention Name: ibandronate[Bonviva/Boniva]

Primary Outcome: 1. Efficacy: Relative change from baseline in total hip bone mineral density (BMD) at 12 months

Key Secondary Outcomes: 1. Efficacy: Relative and absolute change in mean lumbar spine BMD and in trochanter, absolute change in total hip BMD, percent of responders, relative and absolute change from baseline serum CTX Safety: Adverse events, laboratory blood tests

Inclusion Criteria:

  • women 55-84 years of age;
  • postmenopausal for >= 5 years;
  • ambulatory.

Exclusion Criteria:

  • inability to stand or sit upright for 60 minutes;
  • malignant disease diagnosed within the previous 10 years (except basal cell cancer that has been successfully removed);
  • breast cancer within the previous 20 years;
  • allergy to bisphosphonates;
  • previous treatment with an intravenous bisphosphonate at any time;
  • previous treatment with an oral bisphosphonate within the last 6 months, >1 month of treatment within the last year, >3 months of treatment within the last 2 years.

Gender: Females

Age Limits: Min: 55 Years Max: 84 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 06/24/2005

Date Last Updated: 08/18/2008

Link To Trial Results

Contact:

Research Site:
Located In:
San Diego , CA 92161
Telephone: 973-235-5000 or 800-526-6367

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Trial listings updated: September 2, 2008 at 1:56:01 PM


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