Cross-sectional Study of Bone Density, Bone Microarchitecture, Vertebral Fractures and Trabecular Bone Score in Patients With Acromegaly Treated With Pegvisomant Compared to Patients With Untreated Active Acromegaly
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Volumetric bone mineral density of radius (vBMD)
研究概览
简要总结
The investigators will conduct a cross-sectional study of bone density, bone microarchitecture, vertebral fractures and trabecular bone score in 25 patients with acromegaly treated with Pegvisomant, the growth hormone (GH) receptor antagonist for at least 1 year and with normal insulin-like growth factor-1 (IGF-1) levels. This study aims to describe the bone architecture and associated biochemical indices of bone turnover and metabolism in patients with active acromegaly and how these are altered with treatment of the disease.
详细描述
Growth hormone (GH) and Insulin-Like Growth Factor-1 (IGF-1) are important regulators of bone modeling and remodeling, fundamental to maintenance of normal skeletal integrity. In acromegaly, a disease characterized by longstanding exposure to excess GH and IGF-1, these hormones induce marked skeletal changes. Most dual energy X-ray absorptiometry (DXA) studies report that bone mineral density (BMD) is normal in acromegaly. Despite this, however, there is mounting evidence that bone health is adversely affected in patients with both active and successfully treated acromegaly.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Individuals with acromegaly
- •On pegvisomant therapy with a normal IGF-1 level for at least 1 year
排除标准
- •Malignancy (except cured basal, squamous cell skin carcinoma or other cured cancers free from recurrence > 3 years)
- •Pregnancy or lactation within last 12 months
- •Untreated primary hyperparathyroidism, hyper- or hypothyroidism
- •Cushing's syndrome
- •Prolactin-secreting pituitary adenoma
- •GH deficiency
- •On current drug therapy for osteoporosis
- •Diabetes mellitus
- •Renal insufficiency
- •Liver disease
- •Current or past use of glucocorticoids (more than physiologic dose), anticonvulsants, anticoagulants, methotrexate, aromatase inhibitors
研究组 & 干预措施
Acromegaly patients on pegvisomant
25 subjects with acromegaly on pegvisomant therapy with a normal IGF-1 level for at least 1 year.
干预措施: Pegvisomant (Drug)
结局指标
主要结局
Volumetric bone mineral density of radius (vBMD)
时间窗: Measured once at one study visit
Volumetric bone mineral density of radius (vBMD) measured by high resolution peripheral quantitative computed tomography (HRpQCT)
次要结局
- Trabecular number of radius (TbN)(Measured once at one study visit)
- Trabecular Thickness of radius (Tb.Th)(Measured once at one study visit)
- Cortical density of radius(Measured once at one study visit)
- Areal bone mineral density (aBMD) of lumbar sacral spine(Measured once at one study visit)
- Cortical thickness of radius(Measured once at one study visit)
- Trabecular separation of radius (Tb.Sp)(Measured once at one study visit)
- Trabecular bone score of LS spine(Measured once at one study visit)
研究者
Pamela U. Freda
Professor of Medicine
Columbia University