Status:
COMPLETED
Vitamin D and Osteoporosis Prevention in Elderly African American Women
Lead Sponsor:
Winthrop University Hospital
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Determine Effect of Vitamin D on Bone Health in Elderly African American Women
Eligibility:
FEMALE
60+ years
Phase:
PHASE3
Brief Summary
Vitamin D is a hormone that is produced when sunlight is absorbed by the skin. Vitamin D insufficiency has been recognized as a problem in areas where sun exposure is limited, especially in the winter...
Detailed Description
The long-term goal of this project is to develop strategies for the prevention of osteoporotic fractures in African Americans. Most intervention studies have excluded African Americans because of the ...
Eligibility Criteria
Inclusion
- Ambulatory women older than 60 years of age. Self declared as African Americans.
- 20 nmol/L \< serum 25(OH)D level \< 65 nmol/L.
- Willingness to take study drug and participate for four years in the trial.
- Willingness to refrain from the use of self-administered supplements during the trial.
Exclusion
- Serum 25(OH)D levels ≤ 20 nmol/L or ≥ 65 nmol/L.
- BMD total hip below - 2.5 standard deviation (using NHANES III adult young white men and women as the point of reference) or history of osteoporotic fracture.
- Moderate to severe fracture in one or more vertebrae by Instant Vertebral Assessment on DXA.
- Treatment with HRT, SERMS, calcitonin, PTH, androgens, bisphosphonates, phosphate or anabolic steroids during 6 months prior to entry.
- Use of systemic corticosteroids (oral or IV) within the last year at an average dose of greater than 5 mg per day of oral prednisone or equivalent for a period of three months or more prior to screening.
- Hypercalcemia (serum calcium \> 10.6 mg (dl) or history of primary hyperparathyroidism.
- History of chronic liver disease, chronic renal insufficiency, Parkinson's, metabolic bone disease, hematologic tumors, rheumatologic disease requiring steroids, malabsorption or new diagnosis or active treat-ment of cancer 12 months prior to inclusion.
- Use of medications that influence bone metabolism (e.g. anticonvulsants).
- Significant deviation from normal in either: history, physical examination or laboratory tests as evaluated by the Principle Investigator. Participants with a history of hypercalciuria, nephrolithiasis and active sarcoidosis will also be excluded.
- Participation in another investigational trial 30 days prior to screening.
- Spinal disease that affects interpretation of bone densitometry like scoliosis with a Cobb angle greater than 15o, history of surgery at lumbosacral spine.
- Bilateral hip replacement.
- Currently smoking more than 10 cigarettes daily.
- Body width on DXA \> 25 cm.
- Patients who are deemed unsafe to perform muscular function testing as evaluated by the investigator.
- \---------- Study participants should live close to the study site, as this study requires multiple visits over a four year period.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT01153568
Start Date
August 1 2010
End Date
October 1 2016
Last Update
October 3 2018
Active Locations (1)
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1
Winthrop University Hospital
Mineola, New York, United States, 11501