NCT00460057

The Change of Bone Markers After Low Dose Alendronate in Postmenopausal Women With Bone Loss

The Change of Bone Markers After Low Dose Alendronate in Postmenopausal Women

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Eulji University Hospital · Academic / Other
• Sex: Female
• Age: 50 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Osteoporosis

Interventions

Type	Name	Description
DRUG	Alendronate	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

Timeline

• Start date: 2006-03-01
• Primary completion: 2006-12-01
• Completion: 2007-02-01
• First posted: 2007-04-13
• Last updated: 2014-08-05