Osteoporosis (Senile)
Conditions
Keywords
randomized trial,doxercalciferol,bone density spine and femoral neck,
Brief summary
A clinical trial to compare the effect of doxercalciferol or placebo in preventing bone loss from the spine and femur in postmenopausal women
Detailed description
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.
Interventions
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
Sponsors
Creighton University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
double blind , placebo control
Eligibility
Sex/Gender
FEMALE
Age
60 Years to 78 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in spine and femur density over 2 years | Baseline, 6,12,18,24 months at study completion | measurements every 6 months over 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| safety of doxercalciferol on serum and urine calcium excretion | 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 | measurement of serum and 24 hour urine calcium |
Countries
United States
Outcome results
None listed