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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hee-Jeong Choi, Eulji University Hospital
ClinicalTrials.gov Identifier:
NCT00460057
First received: April 12, 2007
Last updated: August 2, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Osteoporosis
Drug: Alendronate
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Eulji University Hospital:

Primary Outcome Measures:
  • 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.


Enrollment: 63
Study Start Date: March 2006
Study Completion Date: February 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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
Other Names:
  • Alendronate
  • Bisphosphonate

  Eligibility

Ages Eligible for Study:   50 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00460057

Sponsors and Collaborators
Eulji University Hospital
Investigators
Principal Investigator: Hee-Jeong Choi, MD, PhD Department of Family medicine, Eulji University Hospital
  More Information

No publications provided

Responsible Party: Hee-Jeong Choi, Associate Professor, Eulji University Hospital
ClinicalTrials.gov Identifier: NCT00460057     History of Changes
Other Study ID Numbers: EJRG-06-001-11E32
Study First Received: April 12, 2007
Last Updated: August 2, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Eulji University Hospital:
osteoporosis
alendronate
bone marker

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014