NCT00532545已完成4 期
Bone Marker Changes In One Month Treatment With TERIPARATIDE (LY333334) Injections (rDNA Origin) in Men and Postmenopausal Women With Severe Osteoporosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- To test the hypothesis that Teriparatide injections given 20 micrograms/daily subcutaneously, for one month, is able to produce reliable changes in the bone marker in a severe osteoporotic population in Puerto Rico.
研究概览
简要总结
To test the hypothesis that Teriparatide injections given 20 micrograms/daily subcutaneously, for one month, are able to produce reliable changes in the bone marker in a severe osteoporotic population
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presents with severe osteoporosis based on the disease diagnostic criteria and upon physician assessment
- •Postmenopausal, nonpregnant, women older than 50 years of age, with previous fracture history such as hip, spine, wrist, ribs, clavicle, humerus, tibia, and fibula or men over 50 years of age with low impact fractures (fragility).
- •Outpatients without concomitant diseases and with life expectancy of at least 3 years, according to the medical criteria.
- •Cannot be on medicines that can disturb bone metabolism.
- •Patients should be capable of self-injection, to learn the use of Pen device and are in agreement with its use.
排除标准
- •Directly affiliated with the conduct of this study, or are the immediate family of someone directly affiliated with the conduct of this study (that is, Lilly employees, investigators, site personnel, or their immediate families). Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- •Received treatment within the last 30 days with a drug (not including study drug) that has not received regulatory approval for any indication at the time of study entry.
- •Previously completed or withdrawn from this study or any other study investigating Teriparatide.
- •Secondary osteoporosis or any disease that affects the bone metabolism, as renal osteodystrophy, osteomalacia, hypoparathyroidism, and hyperparathyroidism, and intestinal malabsorption.
- •Cancer history in the 5 years prior to visit 1, with exemption of basocellular carcinoma treated and cervix carcinoma definitively treated at least 1 year before to visit 1
研究组 & 干预措施
A
Experimental
Teriparatide
干预措施: Teriparatide (Drug)
结局指标
主要结局
To test the hypothesis that Teriparatide injections given 20 micrograms/daily subcutaneously, for one month, is able to produce reliable changes in the bone marker in a severe osteoporotic population in Puerto Rico.
次要结局
- To test the hypothesis that this group of patients will have a high score in the survey used by IOF as an instrument to check risk factors.
- Test the hypothesis that patients will have a high score in the survey used by IOF as an instrument to check risk factors.
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Bone Effects of Teriparatide Following AlendronateOsteoporosisNCT00191893Eli Lilly and Company66
进行中（未招募）
不适用
Teriparatide (PTH) and Bone Strength in Postmenopausal WomenOsteoporosisNCT01155245University Health Network, Toronto60
已完成
3 期
Study of Teriparatide in the Treatment of Postmenopausal Women With OsteoporosisOsteoporosis, Post-MenopausalNCT00532207Eli Lilly and Company50
已完成
不适用
Effect of once-weekly teriparatide for bone metabolism in praimary osteoprosis patients.JPRN-UMIN000032090Kindai University Hospital Department of Orthopaedic surgery50
已完成
不适用
Effect of once-weekly teriparatide for bone metabolism in primary osteoprosis patients.OsteoprosisJPRN-UMIN000033118Kindai University Hospital, Department of Orthopaedic surgery30