Bone Mineral Density Alterations and Correlations With Bone and Muscle Metabolism Parameters During Menstrual Cessation Due to GnRH Therapy and After Menstrual Restoration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- lumbar spine BMD
研究概览
简要总结
The investigators aim to investigate the effect of menstrual cessation in women with endometriosis treated with GnRH analogs for 6 months on bone mineral density and bone and muscle metabolism parameters and subsequently the effects of menstrual restoration after GnRH analogs discontinuation on the above measured parameters
详细描述
Prospective, open-label, controlled 12month observational study
Premenopausal women with surgically verified endometriosis will receive goserelin 1 injection per month for 6 months. Subsequently goserelin will be discontinued and patients will be monitored for another 6 months after menstrual restoration. Age- and BMI-matched premenopausal, health women will serve as controls. Controls will receive no treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Premenopausal women with surgically verified endometriosis
排除标准
- •Secondary osteoporosis
- •diseases or conditions that could affect bone and/or muscle metabolism
- •any medications that could affect bone and/or muscle metabolism
研究组 & 干预措施
Endometriosis Group
20 premenopausal women with surgically verified endometriosis who will receive goserelin 1 injection per month for 6 months. Subsequently goserelin will be discontinued and patients will be monitored for another 6 months after menstrual restoration.
干预措施: Goserelin Acetate (Drug)
结局指标
主要结局
lumbar spine BMD
时间窗: between baseline and 6 months after goserelin discontinuation
Bone mineral density changes at the lumbar spine measured by dual-energy absorptiometry
次要结局
- femoral neck BMD(between baseline and 6 months after goserelin discontinuation)
- sclerostin(0,6,12 months)
- follistatin(0,3,6,12 months)
- noggin(0,3,6,12 months)
- activin-A(0,3,6,12 months)
- miRs(0,6,12 months)
- periostin(0,3,6,12 months)
- irisin(0,3,6,12 months)
研究者
Athanasios D. Anastasilakis
Consultant of endocrinology
424 General Military Hospital