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

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
Tufts University
ClinicalTrials.gov Identifier:
NCT00357643
First received: July 26, 2006
Last updated: NA
Last verified: June 2005
History: No changes posted
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Effect of Calcium and Vitamin D on Bone Loss From the Hip

Resource links provided by NLM:

U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00357643

Locations
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)
Investigators
Principal Investigator: Bess Dawson-Hughes, MD Tufts University
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00357643     History of Changes
Other Study ID Numbers: U01AG010353
Study First Received: July 26, 2006
Last Updated: July 26, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Tufts University:
calcium
vitamin D
bone loss

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Calcium, Dietary
Vitamin D
Ergocalciferols
 Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 16, 2013