Randomized controlled trial of calcium supplementatio

Not Applicable

• Conditions: Bone loss (Osteoporosis)

• Registration Number: JPRN-UMIN000001176
• Lead Sponsor: IIGATA UNIVERSITY GRADUATE SCHOOL OF MEDICAL AND DENTAL SCIENCES, Department of Community Preventive Medicine, Division of Social and Environmental Medicine

Brief Summary

Intention-to-treat analysis showed less dramatic decreases in spinal BMD for the 500-mg/d calcium supplement group compared to the placebo group (1.2% difference over 2 years, p = 0.027). Per-protocol analysis (≥80% compliance) revealed that spinal BMD for the 500-mg/d and 250-mg/d calcium supplement groups decreased less than the placebo group (1.6%, p = 0.010 and 1.0%, p = 0.078, respectively), and that femoral neck BMD for the 500-mg/d calcium supplement group decreased less relative to the placebo group (1.0%, p = 0.077). A low-dose calcium supplement of 500 mg/d can effectively slow lumbar spine bone loss in perimenopausal and postmenopausal women with habitually low calcium intake, but its effect on the femoral neck is less certain. Calcium supplementation dosage should thus be reassessed.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-06-06
• Study Completion: 2010-11-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 450

Inclusion Criteria

Not provided

Exclusion Criteria

perimenopausa, users of caulcium supplement, female hormones, or corticosteroids, patients undergoing treatment for osteoporosis, liver diseases, kidney disease, endocrinological deseases, or cancers

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tow-year changes in bone mineral density of hip and vertebra

Secondary Outcome Measures

Name	Time	Method
Blood pressure, blood biochemical tests