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

July 26, 2006 updated by: Tufts University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

450

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Human Nutrition Research Center on Aging at Tufts U

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Bone Density of the hip

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tufts University

Collaborators

National Institutes of Health (NIH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1992

Study Completion

February 1, 1996

Study Registration Dates

First Submitted

July 26, 2006

First Submitted That Met QC Criteria

July 26, 2006

First Posted (Estimate)

July 27, 2006

Study Record Updates

Last Update Posted (Estimate)

July 27, 2006

Last Update Submitted That Met QC Criteria

July 26, 2006

Last Verified

June 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U01AG010353 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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