Clinical trial: Vitamin D and Osteoporosis Prevention in Elderly African American Women (NCT01153568)

Eligibility criteria:
Inclusion Criteria:

          1. Ambulatory women older than 60 years of age. Self declared as African Americans.

          2. 20 nmol/L < serum 25(OH)D level < 65 nmol/L.

          3. Willingness to take study drug and participate for four years in the trial.

          4. Willingness to refrain from the use of self-administered supplements during the trial.

        Exclusion Criteria:

          1. Serum 25(OH)D levels ≤ 20 nmol/L or ≥ 65 nmol/L.

          2. 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.

          3. Moderate to severe fracture in one or more vertebrae by Instant Vertebral Assessment
             on DXA.

          4. Treatment with HRT, SERMS, calcitonin, PTH, androgens, bisphosphonates, phosphate or
             anabolic steroids during 6 months prior to entry.

          5. 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.

          6. Hypercalcemia (serum calcium > 10.6 mg (dl) or history of primary hyperparathyroidism.

          7. 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.

          8. Use of medications that influence bone metabolism (e.g. anticonvulsants).

          9. 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.

         10. Participation in another investigational trial 30 days prior to screening.

         11. Spinal disease that affects interpretation of bone densitometry like scoliosis with a
             Cobb angle greater than 15o, history of surgery at lumbosacral spine.

         12. Bilateral hip replacement.

         13. Currently smoking more than 10 cigarettes daily.

         14. Body width on DXA > 25 cm.

         15. 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.
Female
Accepts Healthy Volunteers
Subject must be at least 60 Years old.


Patient description (medical language): A 55-year-old white woman comes for a routine checkup.  She has no significant medical history and does not use tobacco, alcohol, or illicit drugs.  The patient's only medication is an over-the-counter multivitamin.  Family history is notable for a hip fracture in her mother.  Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis.

Patient description (patient's own words): I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis.

Does the patient match the trial criteria? Contradiction