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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00460057
• Other study ID #: EJRG-06-001-11E32
• Status: Completed
• Phase: Phase 4
• First received: April 12, 2007
• Last updated: August 2, 2014
• Start date: March 2006
• Est. completion date: February 2007

Study information

• Verified date: August 2014
• Source: Eulji University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: February 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 65 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eulji University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks	No