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

NCT00460057 | Completed Phase 4

• 1 other identifier: EJRG-06-001-11E32
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoporosis

Keywords

osteoporosis; alendronate; bone marker

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Alendronate, Placebo

PLACEBO COMPARATOR

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

Interventions

Alendronate DRUG

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

Also known as: Bisphosphonate

Alendronate, Placebo

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• postmenopausal women (the ages between 50-65 year) with lumbar spine BMD at least 2.0 SD below the peak young adult mean

You may not qualify if:

• severe osteoporosis
• current medication of osteoposis
• metabolic bone disease
• cancer, stroke etc.

Sponsors & Collaborators

• Eulji University Hospital: lead

MeSH Terms

Conditions

Osteoporosis

Interventions

Alendronate; Diphosphonates

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Officials

• Hee-Jeong Choi, MD, PhD

  Department of Family medicine, Eulji University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 12, 2007
• First Posted: April 13, 2007
• Study Start: March 1, 2006
• Primary Completion: December 1, 2006
• Study Completion: February 1, 2007
• Last Updated: August 5, 2014

Record last verified: 2014-08