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A Study of Bone Turnover Markers in Post-Menopausal Women With Osteoporosis Treated With Monthly Boniva (Ibandronate)

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: Placebo (Drug); Vitamin D and calcium supplementation (Drug); ibandronate [Bonviva/Boniva] (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 study will determine the rapidity of suppression of the bone resorption marker sCTX in post-menopausal women with osteoporosis. Other bone turnover markers will also be evaluated. Patients will be randomised to either monthly Boniva 150mg or placebo, in combination with vitamin D and calcium supplementation. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Clinical Details

Official title: A Randomized Double-blind Study to Determine the Time to Onset of Suppression of the Bone Resorption Marker sCTX With Once-monthly Boniva (Ibandronate) Versus Placebo in the Treatment of Post-menopausal Osteoporosis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Percentage of patients whose sCTX concentration decreases by >=8%.

Secondary outcome:

Percentage of patients whose sCTX concentration decreases by >=8%

Change in BSAP

Change in PTH

AEs and laboratory parameters


Minimum age: 65 Years. Maximum age: N/A. Gender(s): Female.


Inclusion Criteria:

- women who have been newly diagnosed with post-menopausal osteoporosis, requiring


- naive to bisphosphonate treatment,or had bisphosphonate treatment for a maximum of 3

months, at least 5 years before screening. Exclusion Criteria:

- patients on HRT within the last 3 months;

- patients on other osteoporosis medication within the last 3 months;

- sCTX below lower limit, or above 3 times the upper limit, of normal premenopausal


- hypersensitivity to any component of ibandronate;

- contraindication for calcium or vitamin D therapy;

- history of major gastrointestinal upset;

- malignant disease diagnosed within the previous 10 years (except resected basal cell


Locations and Contacts

Ponce 00717-1318, Puerto Rico

San Juan 00927, Puerto Rico

San Juan 00935, Puerto Rico

Beverly Hills, California 90211, United States

La Jolla, California 92093, United States

Augusta, Georgia 30904, United States

Woodbury, Minnesota 55125, United States

Bronx, New York 10461, United States

Hopwood, Pennsylvania 15445, United States

Madison, Wisconsin 53705, United States

Additional Information

Starting date: February 2006
Last updated: August 17, 2015

Page last updated: August 23, 2015

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