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

NCT00460057 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2014-08-05

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Eulji University Hospital

    lead OTHER

Principal Investigators

  • Hee-Jeong Choi, MD, PhD · Department of Family medicine, Eulji University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2006-12-31
Completion
2007-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00460057 on ClinicalTrials.gov