Clareo Health | To Study the Efficacy and Safety of Doxercalciferol on Spinal and Femoral Density in Postmenopausal Osteopenic Women in a Long Term 2 Year Study
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Lead
Creighton University
A double blind study of a new type of vitamin D ,named doxercalciferol ( 1α hydroxyvitamin D2) or placebo is given to study its effect on preventing and treating osteoporosis.The trial was a pilot study for one year that was extended to a second year . We used Dual energy Xray absorptiometry (DEXA) to measure bone density of the spine and proximal femur every 6 months.Safety of the drug was monitored by measuring blood and urine calcium frequently.
The study group was post menopausal women.
Age
60–78
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
postmenopausal women, age 60-78 years
normal general laboratory tests
serum calcium \>10.6 mg/dl (2.65 mmol/L ) or \>0.3 mg/dl (0.075mmol/L) above upper limit of normal on 2 baseline tests,
24-hour urine calcium \< 300mg (7.5mmol) on two baseline tests,
Bone mineral density (BMD) measured by DEXA of the spine vertebrae L2-3 of 0.70-1.05 g/cm2
You may not be if
no significant medical disorder known to affect calcium or bone metabolism- hypercalcemia, active renal stone disease ( more than 1 stone episode/ year) or more than 2 stone episodes in a lifetime, sarcoidosis
any history of cancer (except skin cancer) within the last 10 years,
uncontrolled diabetes with significant proteinuria or fasting blood sugar \> 140mg/dl
alcoholism
prolonged hospitalization , extended immobilizations or arthritis that prevents normal physical activity, hemiplegia, previous hip fracture
no previous treatment with medication known to affect bone and calcium metabolism within the last year; chronic corticosteroid therapy \> 10mg/day thiazides, taking long term bisphosphonates or had them for more than 3 months in the past year, parathyroid hormone or derivatives in the last year, estrogen therapy within the last 6 months, anticonvulsants such as phenytoin ,high dose phenobarbital
