Efficacy and Safety of Doxercalciferol on Spinal and Femoral Density in Postmenopausal Osteopenic Women
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- spine and femur density
研究概览
简要总结
A clinical trial to compare the effect of doxercalciferol or placebo in preventing bone loss from the spine and femur in postmenopausal women
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 78 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
prevention of osteoporosis
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
干预措施: doxercalciferol capsules, Hectorol® (Drug)
doxercalciferol capsules
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
干预措施: Matched Placebo (Capsules) (Drug)
结局指标
主要结局
spine and femur density
时间窗: 2 years
change over time
change in spine and femur density over 2 years
时间窗: 2 years
measurements every 6 months over 2 years
change in spine and femur density over 2 years
时间窗: Baseline, 6,12,18,24 months at study completion
measurements every 6 months over 2 years
次要结局
- 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)