To Study the Efficacy and Safety of Doxercalciferol on Spinal and Femoral Density in Postmenopausal Osteopenic Women in a Long Term 2 Year Study
Completed · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Osteoporosis (Senile)
In brief
A clinical trial to compare the effect of doxercalciferol or placebo in preventing bone loss from the spine and femur in postmenopausal women
Key facts
- Study ID
- NCT07660536
- Run by
- Creighton University
- People needed
- 60
- Starts
- 1989-11-14
- Expected to finish
- 1994-12-23
- Last updated by the study team
- 2026-07-01
Who can join
Age: 60 and older, up to 78. Sex: female. Healthy volunteers: not accepted.
You may qualify 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 qualify 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
- severe chronic illness, chronic renal failure ( serum creatinine >1.4mg/dl ,chronic heart failure,
- any terminal illness
- 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
- BMI > 45kg/m2
Where it is running
- Creighton University Medical center — Omaha, Nebraska, United States
Full record on ClinicalTrials.gov
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