A Study of Bone Turnover Markers in Post-Menopausal Women With Osteoporosis Treated With Monthly Boniva (Ibandronate)
Information source: Hoffmann-La Roche
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post-Menopausal Osteoporosis
Intervention: ibandondronate [Bonviva/Boniva] (Drug); Placebo (Drug); Vitamin D and calcium supplementation (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, +1 973 235 5000
Summary
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: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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
Eligibility
Minimum age: 65 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- women who have been newly diagnosed with post-menopausal osteoporosis, requiring
treatment;
- 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
level;
- 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
cancer).
Locations and Contacts
SAN JUAN 00935, Puerto Rico
PONCE 00717-1318, Puerto Rico
SANTURCE 00909, Puerto Rico
LA JOLLA, California 92093, United States
BEVERLY HILLS, California 90211, 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
Ending date: July 2007
Last updated: June 17, 2008
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