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

This study has been completed.
National Institutes of Health (NIH)
Information provided by:
Tufts University Identifier:
First received: July 26, 2006
Last updated: NA
Last verified: June 2005
History: No changes posted
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.

Condition Intervention Phase
Osteoporosis Drug: Calcium 500 mg/day and vitamin D 700 IU/day Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Effect of Calcium and Vitamin D on Bone Loss From the Hip

Resource links provided by NLM:

Further study details as provided by Tufts University:

Primary Outcome Measures:
  • Bone Density of the hip

Secondary Outcome Measures:
  • Annual and Seasonal patterns of change in bone mineral density of the hip
  • Associations between biochemical, physical and life-style factors
  • Examine influence of clinical status, lifestyle, medication use and season on the occurrence of falls

Estimated Enrollment: 450
Study Start Date: October 1992
Estimated Study Completion Date: February 1996
Detailed 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.

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

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Please refer to this study by its identifier: NCT00357643

United States, Massachusetts
Human Nutrition Research Center on Aging at Tufts U
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts University
National Institutes of Health (NIH)
Principal Investigator: Bess Dawson-Hughes, MD Tufts University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00357643     History of Changes
Other Study ID Numbers: U01AG010353 ( U.S. NIH Grant/Contract )
Study First Received: July 26, 2006
Last Updated: July 26, 2006

Keywords provided by Tufts University:
vitamin D
bone loss

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Vitamin D
Calcium, Dietary
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on September 19, 2017