Vitamin D and Osteoporosis Prevention in Elderly African American Women

Completed · Phase 3 · Has a placebo group

Conditions studied: Determine Effect of Vitamin D on Bone Health in Elderly African American Women

In brief

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 wintertime. In addition, the more pigmented the skin is, the less capable it is of utilizing sunlight to make vitamin D. Vitamin D plays an important role in helping the body absorb calcium and in building strong bones. It has also been shown to improve muscle function in the elderly. As we get older, our vitamin D levels in the blood go down and this may increase the risk for falls and fractures. If we can improve vitamin D status as we age, we may be able to improve muscle strength and decrease the risk of falls and fractures.

Key facts

Study ID

NCT01153568

Run by

Winthrop University Hospital

People needed

260

Starts

2010-08-01

Expected to finish

2016-10-01

Last updated by the study team

2018-10-03

Who can join

Age: 60 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Winthrop University Hospital — Mineola, New York, United States

Full record on ClinicalTrials.gov

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