Effect of Calcium and Vitamin D on Bone Loss From the Hip
1 other identifier
interventional
450
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 1992
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 1992
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 1996
CompletedFirst Submitted
Initial submission to the registry
July 26, 2006
CompletedFirst Posted
Study publicly available on registry
July 27, 2006
CompletedJuly 27, 2006
June 1, 2005
July 26, 2006
July 26, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bone Density of the hip
Secondary Outcomes (3)
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
Interventions
Eligibility Criteria
You may qualify if:
- \>65 years calcium intake \< 1500 mg/day Willing to discontinue calcium and vitamin D pills for 2 months prior to enrollment
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tufts Universitylead
- National Institutes of Health (NIH)collaborator
Study Sites (1)
Human Nutrition Research Center on Aging at Tufts U
Boston, Massachusetts, 02111, United States
Related Publications (3)
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.
PMID: 9278463RESULTDawson-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.
PMID: 24248178DERIVEDPittas 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.
PMID: 17277040DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bess Dawson-Hughes, MD
Tufts University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 26, 2006
First Posted
July 27, 2006
Study Start
October 1, 1992
Study Completion
February 1, 1996
Last Updated
July 27, 2006
Record last verified: 2005-06