Bone Microarchitecture in Osteopenic Postmenopausal Women
The purpose of this trial is to compare the difference in bone microarchitecture of the distal radius at month 12 in postmenopausal osteopenic women treated with risedronate 150mg taken once a month compared to placebo.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A 12-month, Multicenter, Double-blind, Randomized, Parallel Group Study Comparing 150 mg Once-a-month Risedronate and Placebo Using 3-dimensional Micro MRI (Magnetic Resonance Imaging).|
- Percent Change From Baseline in Erosion Index (A Ratio of Curve-like Structures to Plate-like Structures and is a Measure of the Degree of Structural Degradation) of the Distal Radius [ Time Frame: 12 months ] [ Designated as safety issue: No ]
The percent was change from baseline in erosion index at the distal radius between the risedronate and placebo groups at Month 12 (the lower the percent change in erosion index, the greater the improvement of structural degradation); the last valid postbaseline measurement was to be used when the Month 12 value was missing (Last Observation Carried Forward or LOCF).
NOTE: The study was unable to recruit sufficient numbers of patients to meet with the protocol specified numbers, thus it was terminated early after 5 months. No efficacy analyses were performed.
- Erosion Index of the Distal Radius [ Time Frame: 6 months ] [ Designated as safety issue: No ]Study was terminated prior to acquiring any efficacy endpoints. No efficacy analyses were performed.
|Study Start Date:||July 2008|
|Study Completion Date:||February 2009|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
one 150 mg risedronate once a month, orally
tablet, 150 mg once a month for 12 months
Placebo Comparator: 1
Placebo tablet once a month, orally
oral tablet once a month for 12 months
|United States, Arizona|
|Tuscon, Arizona, United States, 85704|
|United States, Nebraska|
|Omaha, Nebraska, United States, 68729|
|United States, Ohio|
|Cincinnati, Ohio, United States, 45201|
|Buenos Aires, Argentina|
|Study Director:||Ana M Balske, MD, PhD||Procter and Gamble|