A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis.

Official Title: “Randomized, Open-label, Multi-center Study to Investigate Patient Preference on Dosing in Women With Postmenopausal Osteoporosis Treated With Once Monthly Ibandronate and Once Weekly Risedronate. A Six Month, Two-sequence and Two-period Crossover Study.”

This 2 arm crossover study will evaluate patient reported preference for either once monthly Boniva (150mg p.o.) or once weekly risedronate (35mg p.o.). Patients with post-menopausal osteoporosis will be randomized to receive Boniva for 3 calendar months or risedronate for 12 weeks; they will then cross over to receive the alternative treatment for a further 12 weeks/3 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Intervention(s) in this Clinical Trial

• Drug: ibandronate [Bonviva/Boniva]
  • 150mg po monthly for 3 months
• Drug: Risedronate
  • 35mg po weekly for 12 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• Proportion of patients preferring monthly dosing with Bonviva over weekly dosing with risedronate
  • Time Frame: 6 months
    Safety Issue?: No

Secondary Measures

• Convenience of monthly Bonviva over weekly risedronate
  • Time Frame: 6 months
    Safety Issue?: No
• Change in serum CTX
  • Time Frame: 12 weeks/3 months
    Safety Issue?: No
• Upper gastrointestinal symptoms
  • Time Frame: 12 weeks/3 months
    Safety Issue?: No
• AEs and laboratory parameters
  • Time Frame: Throughout study
    Safety Issue?: No

Inclusion Criteria:

• ambulatory women with post-menopausal osteoporosis;
• patients who are bisphosphonate-naive, or who have previously received oral daily or i.v. bisphosphonate therapy (fulfilling certain criteria detailed in the protocol).

Exclusion Criteria:

• malignant disease diagnosed within previous 10 years (except for successfully resected basal cell cancer;) breast cancer within previous 20 years;
• inability to stand or sit upright for at least 60 minutes;
• disease/disorder/treatment with drugs known to influence bone metabolism.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 55 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Hoffmann-La Roche Industry

Overall Clinical Trial Officials and Contacts

Clinical Trials Study Director Hoffmann-La Roche  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00377234

Study ID Number: MA19547

ClinicalTrials.gov Identifier: NCT00377234

Health Authority: United States: Food and Drug Administration