Clinical trial: Vitamin D Supplementation in Older Women (NCT00472823)

Eligibility criteria:
Inclusion Criteria:

          -  At least 7 years post-menopause

          -  Serum 25OHD level 5 ng/ml to 20 ng/ml

          -  BMI less than or equal to 40 kg/m2

          -  Willing to discontinue multivitamins that contain vitamin D during the study

        Exclusion Criteria:

          -  Cancer (except basal cell carcinoma) or terminal illness

          -  Previous hip fracture

          -  Hemiplegia (paralysis of one side of the body)

          -  Uncontrolled type I diabetes or fasting blood sugar greater than 140 mg in type II

          -  Kidney stones more than twice in a lifetime

          -  Chronic renal failure

          -  Evidence of chronic liver disease, including alcoholism

          -  Physical conditions such as severe osteoarthritis, rheumatoid arthritis, heart failure
             severe enough to prevent reasonable physical activity

          -  Previous treatment with bisphosphonates (more that 3 months), PTH or PTH derivatives,
             (e.g. Teriparatide or Fluoride) in the last 6 months

          -  Previous treatment within the last 6 months with calcitonin or estrogen

          -  Chronic high dose corticosteroid therapy (more than 10 mg per day) for over 6 months
             and not within the last 6 months

          -  Anticonvulsant therapy

          -  High dose thiazide therapy (more than 37.5 mg)

          -  24 hour urine calcium greater than 290 mg on 2 baseline tests

          -  Serum calcium exceeding upper normal limit on 2 baseline tests

          -  Bone Mineral Density T-score less than -3.0 for spine or hip
Female
No healthy subjects accepted to join the trial.
Subject must be at least 57 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? Entailment