Pathogenesis of Atypical Femur Fractures on Long Term Bisphosphonate Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 738
- 试验地点
- 1
- 主要终点
- Prodromal bone deterioration (PBD)
研究概览
简要总结
The purpose of this protocol is to determine the risk of atypical femoral shaft (thigh bone) fractures after long term fracture prevention therapy with a class of drugs called "bisphosphonates", colloquially referred to as Alendronate, risedronate, Ibandronate, and Zoledronate.
In addition, the study is designed to find out which patient is most likely to develop this potential life changing complication and why. Finally, the results of this study will help clinicians to better understand the reason and thus tailor patient specific treatments...i.e., "the right treatment for the right patient for right duration."
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women with a diagnosis of osteopenia or osteoporosis as defined by Bone Mineral density (BMD)
- •patient treated with BPs for >5 years
- •patients treated with non-BP anti-fracture medications such as...
- •estrogens, raloxifene, calcitonin
- •treatment naive patients
排除标准
- •all men regardless of BMD result
- •patients with obvious traumatic AFF
- •patients with normal BMD (better than -1.0 T-score at spine or proximal hip)
- •unable to take tetracycline
- •previous use of teriparatide
- •known allergies to the following:
- •tetracycline antibiotics
- •meperidine
- •midazolam
结局指标
主要结局
Prodromal bone deterioration (PBD)
时间窗: 5 years
Determine the prevalence of PBD and/or Atypical Femoral Fractures (AFF) in patients with post-menopausal or glucocorticoid related osteoporosis, either treated with bisphosphonate (BP) for more than 2 years or never treated with a BP
次要结局
- Diagnosis of PBD(5 years)
研究者
Sudhaker D Rao, MD
Senior staff physician
Henry Ford Health System