Efficacy and Safety of Denosumab Treatment in Bisphosphonate Unresponsive Postmenopausal Osteoporotic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Bone mineral density
研究概览
简要总结
This study, which was designed as a prospective observational study, was planned to enroll 75 female patients with postmenopausal osteoporosis who had been using bisphosphonates for more than two years and did not respond to treatment. 2 doses of denosumab were administered to the patients every 6 months. Bone mineral density of patients were measured with DEXA at the beginning and end of the study. A total of 66 patients completed the study.
At the end of the study, there was a significant improvement in the femur and lumbar total bone mineral density of the patients compared to the baseline. However, no statistically significant difference was found in terms of the frequency of new fractures.
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
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Being a woman with postmenopausal osteoporosis
- •Being between the ages of 45-85
- •Using bisphosphonate therapy for at least two years
- •Vertebral and/or Femur T score below -2.5
- •Unresponsive to bisphosphonate therapy
- •More than 2% decrease in BMD values despite using bisphosphonates and/or
- •New major fracture development during treatment
排除标准
- •Male gender
- •Being extremely thin (BMI <15) or extremely obese (BMI> 45)
- •Malignancy
- •Severe chronic liver and kidney failure
- •Chronic Steroid use
- •Having an active rheumatic disease
- •Having other secondary causes of osteoporosis (primary hyperparathyroidism etc.).
结局指标
主要结局
Bone mineral density
时间窗: 12 month
Femur and spine bone mineral density measurements of the patients at the baseline and the 12th month were performed using the Dual Energy X-ray Absorptiometry (DEXA) machine (Stratos dR 2D Fan-Beam, DMS company, France).
次要结局
- Major Bone Fracture(12 month)
研究者
Ercan KAYDOK
Asst. Prof. MD.
Nigde Omer Halisdemir University