A Phase 2/3 interventional study of doxercalciferol capsules, Hectorol® and Matched Placebo (Capsules) in Osteoporosis (Senile), sponsored by Creighton University. Completed at 1 site in United States. Open to female participants aged 60 Years to 78 Years. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by Creighton University · Phase 2/3, Interventional, and Prevention
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.
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's enrollment of 60 is below the median of 95 across 1,133 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →Creighton University is the lead sponsor of 126 studies on the registry; 4 are open to participants now.
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Exclusion criteria :
placebo capsule are given in increasing doses weekly from 1 to 5 mcg daily over 6 weeks and continued for 24 months or if serum calcium is elevated at a lower dose then the patient will be continued on the lower dose for 24 months.The change in bone mineral density will be measured at baseline ,12 and 24 months
Drug: Matched Placebo (Capsules)
doxercalciferol capsule are given in increasing doses weekly from 1 to 5 mcg daily over 6 weeks and continued for 24 months or if serum calcium is elevated at a lower dose then the patient will be continued on the lower dose for 24 months.The change in bone mineral density will be measured at baseline ,12 and 24 months
Drug: doxercalciferol capsules, Hectorol®
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
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
efficacy of doxerxalciferol in stimulating calcium absorption
radioactive calcium absorption Ca45
Time frame: Baseline , 6months,12 months
Plan to share: Yes — spine, femur density, serum calcium, urine calcium,
Supporting information: Study protocol, Sap, Csr
No publications or documents are linked to this record.
This study is completed, as verified in Dec 1992. You cannot join it, but the record below documents what was studied.
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Creighton University