The Change of Bone Markers After Low Dose Alendronate in Postmenopausal Women With Bone Loss
Primary Purpose
Osteoporosis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Alendronate
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis focused on measuring osteoporosis, alendronate, bone marker
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Placebo Comparator
Arm Label
Alendronate, Placebo
Arm Description
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).
Outcomes
Primary Outcome Measures
Changes of bone turnover markers
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00460057
First Posted
April 12, 2007
Last Updated
August 2, 2014
Sponsor
Eulji University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00460057
Brief Title
The Change of Bone Markers After Low Dose Alendronate in Postmenopausal Women With Bone Loss
Official Title
The Change of Bone Markers After Low Dose Alendronate in Postmenopausal Women
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
February 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eulji University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
osteoporosis, alendronate, bone marker
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
N/A
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alendronate, Placebo
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Alendronate
Other Intervention Name(s)
Bisphosphonate
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes of bone turnover markers
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hee-Jeong Choi, MD, PhD
Organizational Affiliation
Department of Family medicine, Eulji University Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
The Change of Bone Markers After Low Dose Alendronate in Postmenopausal Women With Bone Loss
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