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

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ClinicalTrials.gov Identifier: NCT00357643
Recruitment Status : Completed
First Posted : July 27, 2006
Last Update Posted : July 27, 2006
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Collaborator:
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Study Description
Brief 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.

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

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
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
Study Start Date : October 1992
Estimated Study Completion Date : February 1996

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Bone Density of the hip

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

Eligibility Criteria

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00357643     History of Changes
Other Study ID Numbers: U01AG010353 ( U.S. NIH Grant/Contract )
First Posted: July 27, 2006    Key Record Dates
Last Update Posted: July 27, 2006
Last Verified: June 2005

Keywords provided by Tufts University:
calcium
vitamin D
bone loss

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