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

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Post-Menopausal Osteoporosis

Intervention: Ibandronate (Drug); Risedronate (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche


This 2-sequence crossover study will evaluate patient reported preference for once-monthly ibandronate (150 mg orally) as opposed to once-weekly risedronate (35 mg orally). Participants with post-menopausal osteoporosis will be randomized to receive one product for three months (12 weeks). They will then cross over to receive the other treatment for three months (12 weeks). The anticipated time on study treatment is 6 months (plus a 15-day follow up period), and the target sample size is 100-500 individuals.

Clinical Details

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.

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of Participants Who Preferred Ibandronate Monthly Dosing to Risedronate Weekly Dosing

Secondary outcome:

Percentage of Participants Who Found Once-monthly Ibandronate to be More Convenient Than Once-weekly Risedronate

Intensity of Upper Gastrointestinal Symptoms

Mean Change From Baseline in Bone Resorption and Bone Formation Markers, Serum C-telopeptide of α-chain of Type I Collagen (CTX) and Bone Specific Alkaline Phosphatase (BSAP)

Median Change From Baseline in Bone Resorption and Bone Formation Markers, Serum C-telopeptide of α-chain of Type I Collagen (CTX) and Bone Specific Alkaline Phosphatase (BSAP)


Minimum age: 55 Years. Maximum age: 80 Years. Gender(s): Female.


Inclusion Criteria:

- ambulatory women with post-menopausal osteoporosis

- patients who are bisphosphonate-naive, or who have previously received oral daily or

intravenous (IV) 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.

Locations and Contacts

Birmingham, Alabama 35294-3708, United States

Mesa, Arizona 85213, United States

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Additional Information

Starting date: May 2006
Last updated: June 25, 2015

Page last updated: August 23, 2015

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