Direct Assessment of Non-Vertebral Fractures in Community Experience (DANCE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,167
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Non-Vertebral Fragility Fractures
研究概览
简要总结
The purpose of this study is to evaluate the long-term effectiveness, safety, and tolerability of FORTEO in a larger, more diverse "real world" population than studied in clinical trials
详细描述
Subjects will be followed through a course of FORTEO therapy for up to 24 months and for an additional 24 months after FORTEO treatment is stopped. Subjects may participate in this study for up to 48 months. All aspects of patient care, including diagnostic and therapeutic interventions, will be chosen and conducted at the discretion of the participating study physician according to their clinical judgment and the local standard of medical care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women who are judged by the study physician to be suitable for FORTEO therapy. The FORTEO product labeling specifies those individuals diagnosed with osteoporosis who are considered to be at high risk for fracture
排除标准
- •Subjects who have an increased baseline risk for osteosarcoma. These include Paget's disease of bone, pediatric populations and young adult patients with open epiphyses, prior external beam or implant radiation therapy involving the skeleton
- •Subjects who have administered FORTEO or PTH therapy for more than two weeks directly before study entry
- •Subjects who have completed a course of FORTEO or PTH therapy of at least 18 months duration before study entry
研究组 & 干预措施
FORTEO (teriparatide)-treated
FORTEO-treated
干预措施: FORTEO (Drug)
结局指标
主要结局
Percentage of Participants With Non-Vertebral Fragility Fractures
时间窗: up to 24 months
Non-vertebral fragility fracture is defined as low trauma fracture, such as a fall from standing height. It is binary outcome (Yes/No). Percentage of participants = number of participants with new Non-Vertebral Fragility Fracture/ number of participants at risk \* 100.
次要结局
- Percentage Change From Baseline in Bone Mineral Density (BMD) at Month 24 Endpoint(Baseline, up to month 24)
- Percentage of Participants With Clinical Vertebral Fractures(up to 24 months)
- Percentage Change From Baseline in Back Pain Score by Visual Analog Scale (VAS) at 24 Month Endpoint(Baseline, Month 24)
- Percentage Change From Baseline in Pain Score by Visual Analog Scale (VAS) at 24 Month Endpoint(Baseline, Month 24)
- Treatment Adherence(up to 24 months)
- Percentage Change From Baseline in Bone Mineral Content (BMC) at Month 24 Endpoint(Baseline, up to month 24)
- Percentage Change From Baseline in Bone Area at Month 24 Endpoint(Baseline, up to month 24)
- Physician Criteria for Initiating FORTEO Therapy(Baseline)