Bone Formation-Resorption Coupling and Osteoporosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- change in spine bone mineral density
研究概览
简要总结
This study looks at the effects of two medications, alendronate and parathyroid hormone, on bone mass and on bone formation and bone breakdown in women with osteoporosis. We will randomly select postmenopausal women who have osteoporosis to receive laboratory-produced human parathyroid hormone (hPTH), or alendronate, or both for 2.5 years. Study participants will return to the study center periodically to have their bone mass measured and to give blood and urine samples for tests of bone formation and breakdown and for other laboratory tests. Those who complete the study are eligible for one or two 12 month extension studies.
详细描述
This is a randomized, prospective, open-label study in which osteoporotic postmenopausal women self-administer synthetic hPTH-(1-34), alendronate, or both, every day for 2.5 years. Participants initially come to Massachusetts General Hospital once a month, and subsequently once every 3-6 months, for measurements of serum and urine indices of bone formation and resorption, serum and urine toxicity tests, and DXA/QCT measurements of bone mass. One-third of the participants take hPTH-(1-34) daily, one-third take alendronate once daily, and one-third take both daily (Phase A, months 0-30).
Participants who complete Phase A are eligible for a 12 month extension study (Phase B, months 30-42), during which any alendronate treatment is continued without change and any hPTH 1-34 treatment is stopped.
Participants who complete Phase B are eligible for a second 12 month extension study (Phase C, months 42-54), during which any alendronate treatment is continued without change and every participant takes hPTH 1-34.
During Phases B and C, these participants come to Massachusetts General Hospital once every 6 months for measurements of serum and urine indices of bone formation and resorption, serum and urine toxicity tests, and DXA/QCT measurements of bone mass.
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
- None
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lumbar spine or hip BMD T-score less than or equal to minus 2.0
- •Postmenopausal at least 5 years
- •Fully ambulatory
- •Able to give informed consent
排除标准
- •No concurrent illnesses that cause bone loss
- •No recent drug treatment for osteoporosis
- •No recent fracture
研究组 & 干预措施
PTH
Human parathyroid hormone [hPTH-(1-34)]
干预措施: Human parathyroid hormone [hPTH-(1-34)] (Drug)
ALN
Alendronate
干预措施: alendronate (Drug)
PTH+ALN
Human parathyroid hormone [hPTH-(1-34)] plus alendronate
干预措施: Human parathyroid hormone [hPTH-(1-34)] (Drug)
PTH+ALN
Human parathyroid hormone [hPTH-(1-34)] plus alendronate
干预措施: alendronate (Drug)
结局指标
主要结局
change in spine bone mineral density
时间窗: study months 30 (phase A), 42 (phase B), 54 (phase C)
次要结局
- change in hip bone mineral density(study months 30 (phase A), 42 (phase B), 54 (phase C))
- change in forearm bone mineral density(study months 30 (phase A), 42 (phase B), 54 (phase C))
- change in total body bone mineral(study months 30 (phase A), 42 (phase B), 54 (phase C))
- change in femoral shaft bone mineral density(study months 30 (phase A), 42 (phase B), 54 (phase C))
- change in serum PINP(study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C))
- change in serum osteocalcin(study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C))
- change in serum NTX(study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C))
- incidence of hypercalcemia(study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C))
- incidence of hypercalciuria(study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C))
- incidence of symptoms(study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C))
研究者
Robert M. Neer, MD
Physician
Massachusetts General Hospital