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A Randomized, Double-blind, Placebo-controlled Study to Determine Time to Onset of Suppression of the Bone Resorption Marker sCTX With Once Monthly Ibandronate in the Treatment of Postmenopausal Osteoporosis
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 approximately 7 months, and the target sample size is \<100 individuals.
Age
65 - No limit years
Sex
FEMALE
Healthy Volunteers
Yes
Beverly Hills, California, United States
La Jolla, California, United States
Augusta, Georgia, United States
Woodbury, Minnesota, United States
The Bronx, New York, United States
Hopwood, Pennsylvania, United States
Madison, Wisconsin, United States
Ponce, Puerto Rico
San Juan, Puerto Rico
San Juan, Puerto Rico
Start Date
February 1, 2006
Primary Completion Date
June 1, 2007
Completion Date
June 1, 2007
Last Updated
May 2, 2016
67
ACTUAL participants
Placebo
DRUG
Vitamin D and calcium supplementation
DRUG
ibandronate [Bonviva/Boniva]
DRUG
Lead Sponsor
Hoffmann-La Roche
NCT05571514
NCT02347865
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT00377234