NCT06344650招募中不适用
Cellular, Molecular and Clinical Determinants of Bone Strength in in Vivo and Human Models of GH Excess. Cross-sectional and Prospective Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Identify the rate of morphometric vertebral fractures in acromegalic patients
研究概览
简要总结
Prospective observational clinical, molecular, translational study aimed at identifying the main determinants and predictive factors of fragility fracture risck in acromegaly patients
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmed diagnosis of acromegaly
- •availability to carry out outpatient checks
- •ability to provide informed consent
排除标准
- •Pregnancy
- •use of glucocorticoids (except those in use for replacement therapy)
- •alcohol abuse
- •exacerbation of chronic disease
- •serious comorbidities (renal or hepatic failure, heart attack, stroke)
- •terminally ill, prolonged immobilization (>1 week)
- •clinically evident fracture within the previous six months
- •any other cause of secondary osteoporosis within the last five years
- •any prolonged treatment with drugs with documented influence on bone metabolism during the previous 12 months, including treatment with antiresorptive or anabolic compounds for osteoporosis.
结局指标
主要结局
Identify the rate of morphometric vertebral fractures in acromegalic patients
时间窗: 18 months
Identify the rate of morphometric vertebral fractures in acromegalic patients 18 months after hospitalization for neurosurgery
次要结局
未报告次要终点
研究者
Andrea Giustina
Head of Endocrinology
IRCCS Ospedale San Raffaele
研究点 (1)
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