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

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Calcium 500 mg/day and vitamin D 700 IU/day
Sponsored by
Tufts University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis focused on measuring calcium, vitamin D, bone loss

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Human Nutrition Research Center on Aging at Tufts U

Outcomes

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

Full Information

First Posted
July 26, 2006
Last Updated
July 26, 2006
Sponsor
Tufts University
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00357643
Brief Title
Effect of Calcium and Vitamin D on Bone Loss From the Hip
Official Title
Effect of Calcium and Vitamin D on Bone Loss From the Hip
Study Type
Interventional

2. Study Status

Record Verification Date
June 2005
Overall Recruitment Status
Completed
Study Start Date
October 1992 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 1996 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Tufts University
Collaborators
National Institutes of Health (NIH)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
calcium, vitamin D, bone loss

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
450 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Calcium 500 mg/day and vitamin D 700 IU/day
Primary Outcome Measure Information:
Title
Bone Density of the hip
Secondary Outcome Measure Information:
Title
Annual and Seasonal patterns of change in bone mineral density of the hip
Title
Associations between biochemical, physical and life-style factors
Title
Examine influence of clinical status, lifestyle, medication use and season on the occurrence of falls

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bess Dawson-Hughes, MD
Organizational Affiliation
Tufts University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Human Nutrition Research Center on Aging at Tufts U
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9278463
Citation
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. doi: 10.1056/NEJM199709043371003.
Results Reference
result
PubMed Identifier
24248178
Citation
Dawson-Hughes B, Harris SS, Ceglia L, Palermo NJ. Serum sclerostin levels vary with season. J Clin Endocrinol Metab. 2014 Jan;99(1):E149-52. doi: 10.1210/jc.2013-3148. Epub 2013 Dec 20.
Results Reference
derived
PubMed Identifier
17277040
Citation
Pittas AG, Harris SS, Stark PC, Dawson-Hughes B. The effects of calcium and vitamin D supplementation on blood glucose and markers of inflammation in nondiabetic adults. Diabetes Care. 2007 Apr;30(4):980-6. doi: 10.2337/dc06-1994. Epub 2007 Feb 2.
Results Reference
derived

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

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