Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
doxercalciferol, Hectorol · 1 trial · 1 indication
change over time
measurements every 6 months over 2 years
| Arm | Type | Description |
|---|---|---|
| doxercalciferol capsules | PLACEBO_COMPARATOR | 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 |
| prevention of osteoporosis | EXPERIMENTAL | 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 |
| Name | Type | Description |
|---|---|---|
| doxercalciferol capsules, Hectorol® | DRUG | 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 |
| Matched Placebo (Capsules) | DRUG | 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 |
Inclusion Criteria:normal baseline serum and urinary biochemical parameters .spine density 0.70-1.05g/cm2, - Exclusion Criteria:significant medical disorders, recent use of medications known to affect bone or calcium metabolism, history of renal calculi, previous prolonged hospitalization or other ...
Doxercalciferol, also known as Hectorol, is being studied for its effect on bone mineral density of the spine and femur in postmenopausal women with osteopenia. It is a small molecule in Phase 2 clinical development for this musculoskeletal condition.
Doxercalciferol is a synthetic vitamin D analog. It works by binding to the vitamin D receptor, which helps regulate calcium and phosphate metabolism, thereby influencing bone mineral density. This mechanism is relevant to its study in postmenopausal osteopenic women.
Doxercalciferol is being developed by Bone Biologics Corp, a company traded on the NASDAQ under the ticker symbol BBLG. The company is conducting clinical trials to evaluate the drug's efficacy and safety for improving bone mineral density.
Doxercalciferol is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA for the indication of bone mineral density of the spine and femur. One Phase 2 trial has been completed.
Doxercalciferol has one completed Phase 2 trial, NCT07660536, which studied its efficacy and safety on spinal and femoral density in postmenopausal osteopenic women over two years. The trial enrolled 60 female participants aged 60 years and older in the United States.
Yes, doxercalciferol is also known as Hectorol. Both names refer to the same drug substance, which is being investigated by Bone Biologics Corp for its potential to improve bone mineral density in postmenopausal women with osteopenia.