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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

April 12, 2007
August 2, 2014
March 2006
December 2006   (final data collection date for primary outcome measure)
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.
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Complete list of historical versions of study NCT00460057 on ClinicalTrials.gov Archive Site
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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

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.

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Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Osteoporosis
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
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).
Intervention: Drug: Alendronate
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
February 2007
December 2006   (final data collection date for primary outcome measure)

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.
Female
50 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT00460057
EJRG-06-001-11E32
No
Hee-Jeong Choi, Eulji University Hospital
Eulji University Hospital
Not Provided
Principal Investigator: Hee-Jeong Choi, MD, PhD Department of Family medicine, Eulji University Hospital
Eulji University Hospital
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP