The Change of Bone Markers After Low Dose Alendronate in Postmenopausal Women With Bone Loss
Information source: Eulji University Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoporosis
Intervention: Alendronate (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Eulji University Hospital Official(s) and/or principal investigator(s):
Hee-Jeong Choi, MD, PhD, Principal Investigator, Affiliation: Department of Family medicine, Eulji University Hospital
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.
Clinical Details
Official title: The Change of Bone Markers After Low Dose Alendronate in Postmenopausal Women
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Changes of bone turnover markers
Eligibility
Minimum age: 50 Years.
Maximum age: 65 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- postmenopausal women (the ages between 50-65 year) with lumbar spine BMD at least 2. 0
SD below the peak young adult mean
Exclusion Criteria:
- severe osteoporosis
- current medication of osteoposis
- metabolic bone disease
- cancer, stroke etc.
Locations and Contacts
Additional Information
Starting date: March 2006
Last updated: August 2, 2014
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