Effect of Calcium and Vitamin D on Bone Loss From the Hip

Osteoporosis Clinical Trial

Official title:

Effect of Calcium and Vitamin D on Bone Loss From the Hip

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00357643
• Other study ID #: U01AG010353
• Status: Completed
• Phase: Phase 3
• First received: July 26, 2006
• Last updated: July 26, 2006
• Start date: October 1992
• Est. completion date: February 1996

Study information

• Verified date: June 2005
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The primary aim of this study is to determine the effects of supplementation with both calcium and vitamin D on changes in bone density of the hip in men and women age 65 and older.

Description:

In this study 445 men and women age 65 and older were enrolled for three years each. Subjects were randomized to treatment with 500 mg of calcium s calcium citrate malate plus 700 IU of vitamin D daily or placebo. Subjects came to the research center every six months for biochemical and bone mineral density measurements. Changes in these measures over the three years were determined in each group and compared.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: February 1996
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

>65 years calcium intake < 1500 mg/day Willing to discontinue calcium and vitamin D pills for 2 months prior to enrollment

Exclusion Criteria:

Mentally incompetent, femoral neck BMD greater than 2 SD above/below age/sex-matched reference mean, 24-hr urine calcium/creatinine > 300 mg/d women or >350 mg/d men terminal illness, renal disease requiring treatment, kidney stone in the past 10 years, current hyperparathyroidism, treated with glucocorticoids, estrogen or androgen, fluoride, calcitonin, bisphosphonate, or any other treatment for osteoporosis.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Calcium 500 mg/day and vitamin D 700 IU/day

Locations

Country	Name	City	State
United States	Human Nutrition Research Center on Aging at Tufts U	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Tufts University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Dawson-Hughes B, Harris SS, Krall EA, Dallal GE. Effect of calcium and vitamin D supplementation on bone density in men and women 65 years of age or older. N Engl J Med. 1997 Sep 4;337(10):670-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Density of the hip
Secondary	Annual and Seasonal patterns of change in bone mineral density of the hip
Secondary	Associations between biochemical, physical and life-style factors
Secondary	Examine influence of clinical status, lifestyle, medication use and season on the occurrence of falls