A clinical trial to compare the effect of doxercalciferol or placebo in preventing bone loss from the spine and femur in postmenopausal women
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
60
doxercalciferol capsules given in escalating doses from 1mcg to 5mcg daily.If serum calcium is elevated at any dose then that dose is maintained long term for 24 months.The change in bone mineral density will be measured at baseline ,12 and 24 months
oral doses increased from 1 to 5mcg once daily until serum calcium is elevated and given for 2 years.The change in bone mineral density will be measured at baseline ,12 and 24 months
Creighton University Medical center
Omaha, Nebraska, United States
change in spine and femur density over 2 years
measurements every 6 months over 2 years
Time frame: Baseline, 6,12,18,24 months at study completion
safety of doxercalciferol on serum and urine calcium excretion
measurement of serum and 24 hour urine calcium
Time frame: From enrollment ,measurements at baseline, weeks 1,2,3,4,5,12 after first dose, then every 3 months until study completion at 24 months
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