Trial Information

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

Status: Completed

Protocol Number: MA17843

Sponsor: F Hoffman-La Roche Ltd

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open-label, muti-center study to investigate patient preference on dosing in women with postmenopausal osteoporosis treated with once-monthly ibandronate and once-weekly alendronate. A six month, two-sequence, and two-period crossover study.

Brief Summary: This study will evaluate patient-reported preference for either Bonviva or a comparator drug in women with postmenopausal osteoporosis. The anticipated time of study treatment is 3-6 months, and the target sample size is 100-500 individuals. Target sample size is 338.

Study Phase: IV

Study Design / Study Details:

  • Purpose: Treatment
  • Allocation: Randomized
  • Masking: Open Label
  • Control: Active
  • Assignment: Crossover
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

Condition: Post-Menopausal Osteoporosis

Intervention Type: Drug

Intervention Name: ibandronate[Bonviva/Boniva]

Primary Outcome: 1. Proportion (%) of patients preferring once-monthly dosing of ibandronate over once-weekly dosing of alendronate

Key Secondary Outcomes: 1. Proportion (%) of patients perceiving the once-monthly dosing of ibandronate to be more convenient over once-weekly dosing of alendronate. Explore characteristics of preferred medication. Safety: Adverse events and laboratory tests

Inclusion Criteria:

  • ambulatory women;
  • diagnosis of post-menopausal osteoporosis;
  • women who have never received bisphosphonate therapy, or who have discontinued daily bisphosphonates at least 3 months prior to study entry.

Exclusion Criteria:

  • inability to stand or sit in the upright position for >=60 minutes;
  • allergy to bisphosphonates;
  • previous or current treatment with weekly or monthly bisphosphonates, or daily bisphosphonates for the last 3 months prior to study entry.

Gender: Females

Age Limits: Min: Years

Accepts Healthy Volunteers: No

Trial Registration Date: 06/24/2005

Date Last Updated: 09/19/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Santa Clarita, CA 91321
Telephone: 973-235-5000 or 800-526-6367

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Trial listings updated: October 6, 2008 at 2:56:54 PM


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