NCT00670501已完成3 期
Effects of LY333334 in the Treatment of Postmenopausal Women With Osteoporosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,637
- 试验地点
- 1
- 主要终点
- To demonstrate a reduction in the proportion of patients with new vertebral fractures (by spinal x-ray) following 3-year treatment with 20 and 40 micrograms/day of LY333334 plus calcium and vitamin D compared with calcium and vitamin D alone.
研究概览
简要总结
The primary objective of this study is to demonstrate a reduction in the proportion of new vertebral fractures in postmenopausal women with osteoporosis following 3-years of treatment with 20 and 40 mcg/day of teriparatide plus calcium and vitamin D compared with calcium and vitamin D alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ambulatory, postmenopausal women.
- •A minimum of either one moderate or two mild atraumatic vertebral fractures, and a minimum of seven evaluable nonfractured vertebrae.
- •Hip BMD or lumbar spine BMD measurement at least 1.0 standard deviation (SD) below the average bone mass for young, healthy women (T-score) only in patients with fewer than two moderate fractures or in patients previously treated with therapeutic doses of bisphosphonates or fluorides
- •Normal or clinically nonsignificant abnormal laboratory values (serum calcium, PTH(1-84), & urine calcium must be within normal limits at baseline; 25-hydroxyvitamin D must be between the lower limit of normal & 3 times the upper limit of normal at baseline).
排除标准
- •Fractures in areas of bone affected by diseases other than osteoporosis (for example, cancer or Paget's disease).
- •Satisfactory baseline thoracic and lumbar spinal x-ray views cannot be obtained as determined by the centralized x-ray quality assurance center (for example, severe scoliosis or kyphosis).
- •Current or recent (within 1 year prior to randomization) metabolic bone disorders other than postmenopausal osteoporosis, such as Paget's disease, renal osteodystrophy, osteomalacia, or any secondary causes of osteoporosis
- •Current or recent (within 1 year prior to randomization) disease which affects bone metabolism, such as hypoparathyroidism, hyperparathyroidism, or hyperthyroidism.
- •Currently suspected carcinoma or history of carcinoma in the 5 years prior to randomization.
- •Nephrolithiasis or urolithiasis in the 2 years prior to randomization.
- •Current or recent (within 1 year prior to randomization) sprue, inflammatory bowel disease, or malabsorption syndrome, or any indication of poor intestinal absorption of calcium, such as the combination of a low urinary calcium excretion and an elevated serum intact parathyroid hormone level.
- •Poor medical or psychiatric risk for treatment with an investigational drug, in the opinion of the investigator.
- •Treatment with androgens or other anabolic steroids in the 6 months prior to randomization.
- •Treatment with calcitonins in the 2 months prior to randomization.
- •Treatment with estrogen
- •Treatment with progestins in the 3 calendar months prior to randomization, or for more than 2 months in the 12 calendar months prior to randomization.
- •Treatment with corticosteroids.
- •Treatment with fluorides in the 6 months prior to randomization or for more than 60 days in the 24 months prior to randomization.
- •Treatment with oral bisphosphonates in the 3 months prior to randomization or for more than 60 days in the 24 months prior to randomization; treatment with intravenous bisphosphonates in the 24 months prior to randomization.
- •Treatment with vitamin D >50,000 IU/week, or with any dose of calcitriol, analogs, or agonists in the 6 months prior to randomization. The 25-hydroxyvitamin D laboratory value at randomization must be between the lower limit of normal and three times the upper limit of normal.
- •Treatment with coumarins and indandione derivatives in the 3 months prior to randomization; treatment with heparins >10,000 U/day for more than 30 days in the 6 months prior to randomization.
- •Treatment with calcium- or aluminum-containing antacids
- •Treatment with any other drug known to affect bone metabolism in the 6 months prior to randomization.
- •Treatment with any investigational drug during the month prior to the calcium and vitamin D run-in phase. Treatment with investigational drugs in certain therapeutic classes during the month prior to the calcium & vitamin D run-in phase.
研究组 & 干预措施
1
Experimental
LY333334 40 micrograms/day plus calcium and vitamin D
干预措施: teriparatide (Drug)
1
Experimental
LY333334 40 micrograms/day plus calcium and vitamin D
干预措施: Calcium Supplement (Drug)
1
Experimental
LY333334 40 micrograms/day plus calcium and vitamin D
干预措施: Vitamin D Supplement (Drug)
2
Experimental
LY333334 20 micrograms/day plus calcium and vitamin D
干预措施: teriparatide (Drug)
2
Experimental
LY333334 20 micrograms/day plus calcium and vitamin D
干预措施: Calcium Supplement (Drug)
2
Experimental
LY333334 20 micrograms/day plus calcium and vitamin D
干预措施: Vitamin D Supplement (Drug)
3
Placebo Comparator
Placebo plus calcium and vitamin D
干预措施: Placebo (Drug)
3
Placebo Comparator
Placebo plus calcium and vitamin D
干预措施: Calcium Supplement (Drug)
3
Placebo Comparator
Placebo plus calcium and vitamin D
干预措施: Vitamin D Supplement (Drug)
结局指标
主要结局
To demonstrate a reduction in the proportion of patients with new vertebral fractures (by spinal x-ray) following 3-year treatment with 20 and 40 micrograms/day of LY333334 plus calcium and vitamin D compared with calcium and vitamin D alone.
时间窗: Baseline, randomization, 24 , 36, and 60 months
次要结局
- To establish the effect of long-term treatment with LY333334 plus calcium and vitamin D, compared with calcium and vitamin D alone, on lumbar spine and hip BMD in postmenopausal women with osteoporosis(Lumbar Spine: Randomization -2wks, Randomization,( 3 & 6 months in a subset of pts), 12 , 18 , 24 , 36 , 48 & 60 months. Hip BMD: Randomization -2wks, Randomization, 12 , 24 , 36 , 48 & 60 months.)
- To establish the effect of long-term treatment with LY333334 plus calcium and vitamin D, compared with calcium and vitamin D alone, on total body and radial (forearm) BMD in postmenopausal women with osteoporosis at selected study sites(Randomization, 12, 24, 36, 48 and 60 months)
- To establish the effect of long-term treatment with LY333334 plus calcium and vitamin D, compared with calcium and vitamin D alone, on the rate of new vertebral fractures (by spinal x-ray) in postmenopausal women with osteoporosis.(Baseline, randomization, 24 months, 60 months)
- To establish the effect of treatment with LY333334 plus calcium & vitamin D, compared with calcium & vitamin D alone, by x-ray on the proportion of subjects experiencing new nonvertebral fractures alone & new nonvertebral & vertebral fractures combined.(As clinically needed throughout the trial)
- To assess the effect of long-term treatment with LY333334 plus calcium and vitamin D, compared with calcium and vitamin D alone, on height (via Harpenden stadiometer or other suitable stadiometer) in postmenopausal women with osteoporosis(Randomization, 12, 24, 36, 48, and 60 months)
- To determine the histomorphometric effects of LY333334 plus calcium & vitamin D, compared with calcium & vitamin D alone by biopsy, on the iliac crest (bone formation & resorption, mineralization, and trabecular structure) in a subset of subjects.(Randomization, 12 and 24 months)
- To assess effects of LY333334 plus calcium & vitamin D, compared with calcium & vitamin D alone, on biochemical markers of bone formation & resorption (bone-specific alkaline phosphatase, PICP, urinary N-telopeptide, & urinary free deoxypyridinolines)(Randomization, 1, 3, 6, 12, 24, 36, 48, and 60 months)
- To assess population pharmacokinetics of LY333334 at selected study sites. Nonlinear mixed effect modeling [NONMEM])and or PTH(1-84) will be employed to evaluate serum concentrations of LY333334.(Months 1, 3, 6, 12, 18, 24, 30, 36 and 60)
- To quantify medical resources used by patients during the study so that a cost-effectiveness analysis can be performed.(Randomization, 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 Months)
- To assess the impact of LY333334 on health-related quality of life in postmenopausal women with osteoporosis. Quality of life instruments will be completed where translated and validated instruments are available.(Randomization, 12, 24, 36, 48, and 60 months)
- To establish the safety of chronic administration of LY333334 in postmenopausal women with osteoporosis. Adverse events, physical examinations and laboratory tests will be used to assess safety in the patients.(Adverse Events: throughout the trial. Labs:Baseline, randomization, 1, 6, 12, 24, 36, 48, and 60 months. Physical Exams: 12, 24, 36, 48, and 60 months)
研究者
研究点 (1)
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