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Completed
NCT07660536
To Study the Efficacy and Safety of Doxercalciferol on Spinal and Femoral Density in Postmenopausal Osteopenic Women in a Long Term 2 Year Study
Conditions: Osteoporosis (Senile)
Sex: Female
Ages: 60 Years – 78 Years
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 60
Sponsor: Creighton University
Location: Creighton University Medical center Omaha Nebraska
Summary
A clinical trial to compare the effect of doxercalciferol or placebo in preventing bone loss from the spine and femur in postmenopausal women
Eligibility Criteria
Inclusion criteria:
* 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
Exclusion criteria :
* 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
Source: ClinicalTrials.gov (NCT07660536). StuddyBuddy aggregates publicly available trial information.