NCT00761332已完成不适用
An Observational Study to Assess Back Pain in Patients With Severe Osteoporosis Treated With Teriparatide Versus Antiresorptives
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 650
- 试验地点
- 1
- 主要终点
- New or worsening back pain as measured by a specific question in the Back Pain Questionnaire
研究概览
简要总结
The purpose of this study is to compare the effectiveness of teriparatide versus therapies that decrease bone loss to prevent new or worsening back pain in patients with osteoporosis seen in clinical practice.
详细描述
Study B3D-CR-B013 is a prospective observational study to compare changes in back pain among patients treated with teriparatide versus those treated with antiresorptives (raloxifene, daily or weekly bisphosphonates).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and postmenopausal women who have a previous vertebral osteoporotic fracture that was sustained at least 6 weeks prior to joining the study.
- •Patients who are free of severe or chronically disabling conditions other than osteoporosis.
- •Patients who are not currently receiving and have not previously received teriparatide.
- •Patients who agree to participate, return to follow-up visits, and who have signed informed consent to participate in the study.
- •Patients, who in the opinion of the prescribing physician, are eligible to receive the intended treatment and comply with all the recommendations stated in the relevant product information.
排除标准
- •Are investigator site personnel directly affiliated with the study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- •Are Lilly employees (that is, employees, temporary contract workers, or designees responsible for conducting the study). Immediate family of Lilly employees may participate in Lilly-sponsored clinical trials, but are not permitted to participate at a Lilly facility.
- •Patients who have any contraindications according to the relevant product information in the country in which they are being treated.
- •Patients who are simultaneously participating in a different study that includes a treatment intervention and/or an investigational drug.
研究组 & 干预措施
Teriparatide
Patients treated with teriparatide
干预措施: teriparatide (Drug)
Antiresorptive
Patients treated with antiresorptive therapy
干预措施: antiresorptives (Drug)
结局指标
主要结局
New or worsening back pain as measured by a specific question in the Back Pain Questionnaire
时间窗: 12 months
次要结局
- Treatment persistence, (days on therapy)(12 months)
- Changes in health-related quality of life by completing the EuroQoL Scale (EQ-5D)(12 months)
- Incidence of nontraumatic osteoporotic fractures(12 months)
- Incidence of adverse events(12 months)
- Risk of developing moderate or severe back pain(12 months)
- Changes in back pain severity using a Visual Analog Scale(12 months)
研究者
研究点 (1)
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