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

Eulji University Hospital

Status and phase: Completed; Phase 4

Conditions: Osteoporosis

Treatments: Drug: Alendronate

Study type: Interventional

Funder types: Other

Identifiers

NCT00460057

EJRG-06-001-11E32

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: Female

Ages: 50 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Double Blind

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63 participants in 1 patient group, including a placebo group

Alendronate, Placebo

Placebo Comparator group

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).

Treatment:

Drug: Alendronate