The Change of Bone Markers After Low Dose Alendronate in Postmenopausal Women With Bone Loss
High bone turnover with the bone resorption exceeding bone formation is a major mechanism of postmenopausal osteoporosis. Therefore, inhibition of bone resorption is a rational approach for the prevention. The Objective of the current study was to determine the short-term efficacy of once-weekly low dose alendronate in the prevention of bone loss in early postmenopausal Korean women with moderate bone loss via bone turnover markers.
This study was a 12-week, randomized, double-blind clinical trial compared the effects of placebo with alendronate 20 mg once weekly. All subjects received supplemental calcium 600 mg and vitamin D 400 IU daily. Fifty two postmenopausal women (the ages between 50-65 year) with lumbar spine BMD at least 2.0 SD below the peak young adult mean were recruited at Eulji University Hospital, Daejeon, Korea. BMD was measured by DXA at baseline and serum alkaline phosphatase, osteocalcin and C-terminal telopeptide of type I collagen was measured at baseline and 12 weeks after treatment.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||The Change of Bone Markers After Low Dose Alendronate in Postmenopausal Women|
- Changes of bone turnover markers [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]to determine the short-term efficacy of once-weekly low-dose alendronate, via bone turnover markers and OPG, in the prevention of bone loss in early postmenopausal Korean women with moderate bone loss.
|Study Start Date:||March 2006|
|Study Completion Date:||February 2007|
|Primary Completion Date:||December 2006 (Final data collection date for primary outcome measure)|
Placebo Comparator: Alendronate, Placebo
All subjects were given 600 mg of calcium and 400 IU of vitamin D supplements. The subjects were randomized to receive weekly alendronate 20 mg (n = 31) or placebo (n = 32).
Take two tablets (alendronate 10 mg) once weekly with a full glass of plain water in the morning after an overnight fast and to refrain from lying down or taking any other beverage or food for at least 1 h thereafter
Please refer to this study by its ClinicalTrials.gov identifier: NCT00460057
|Principal Investigator:||Hee-Jeong Choi, MD, PhD||Department of Family medicine, Eulji University Hospital|