Prevalenza Dell'Ipercortisolismo Occulto Nell'Osteoporosi
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 5
- 主要终点
- Prevalence of hidden hypercortisolism in patients with osteoporosis or osteopenia plus the comorbidities possibly associated with cortisol excess
研究概览
简要总结
The goals of this observational study are the following:
i) to assess the prevalence of hidden hypercortisolism (HidHyCo) in a sample of osteoporotic patients; ii) to compare the clinical characteristics between osteoporotic/osteopenic patients with HidHyCo and those without HidHyCo in order to determine the clinical characteristics more frequently associated with the HidHyCo presence in the osteoporotic population and to identify those osteoporotic patients worthy of HidHyCo screening.
In all patients who have been included in the study and who have given the informed consent to participate in the study we will perform 1 mg overnight dexamethasone suppression test (F-1mgDST).
In all subjects with F-1mgDST >1.8 mcg/dL, cortisol levels after two-day low dose (2 mg/day) dexamethasone suppression test (F-2mgx2dDST) will be measured.
Patients with F-2mgx2dDST above >1.8 mcg/dL will be considered affected with HidHyCo and will be managed following the available guidelines for hypercortisolism.
The HidHyCo could be present in a not negligible percentage of osteopenic/osteoporotic patients. In these patients, osteoporosis and, if present, other comorbidities (i.e. hypertension and/or diabetes) can improve by the surgical resection of the adrenal or pituitary adenoma if feasible, or by the use of drugs able to modulate cortisol secretion or glucocorticoid sensitivity.
详细描述
Clinically overt hypercortisolism (i.e. Cushing's syndrome) leads to hypertension, central obesity, diabetes and osteoporosis.
More recently, even the condition of mild and asymptomatic hypercortisolism has been associated with increased prevalence of chronic complications of cortisol excess and mortality. In patients with osteoporosis this form of hypercortisolism may remain occult (hidden hypercortisolism, HidHyCo), until its presence is suspected on the basis of particular characteristics of the underlying disease.
By definition, HidHyCo is a condition of cortisol excess in the absence of its classical signs and symptoms. Although asymptomatic, however, this subtle cortisol excess is associated with an increased risk of osteoporosis and fragility fractures.
Moreover, HidHyCo prevalence seems to be increased in osteoporotic patients. In particular, the prevalence of HidHyCo in patients with low bone mineral density and with fragility fracture has been reported to be 1.7-9.9% and 1.9-17.6%, respectively.
The HidHyCo case finding is of utmost importance since these patients experience an impressive reduction of the fracture risk after the normalization of cortisol levels. However, given the high prevalence of bone fragility and the relatively low diagnostic accuracy of the currently available tests for the HidHyCo detection, a mass screening for HidHyCo is considered unthinkable. Therefore, the issue of which osteoporotic patient has to be screened for HidHyCo has recently become a widely debated topic, but as now, no guidelines are available for addressing the HidHyCo screening in osteoporosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •presence of osteoporosis (i.e. lumbar and/or femoral BMD T-score < -2.5 and/or Z-score < -2.0 and/or fragility fracture of hip, spine, wrist, humerus, malleolus or ribs);
- •presence of osteopenia (i.e. lumbar and/or femoral BMD T-score between -1.0 and -2.5) in addition to hypertension treated with at least 2 drugs or not well controlled hypertension (sustained blood pressure above 150/100 mmHg) and/or diabetes and/or to a history of cardiovascular events (such as deep vein thrombosis, coronary heart disease, myocardial infarction, stroke).
排除标准
- •pregnancy/breastfeeding, sleep apnea, prepuberal onset of hypertension, hormonal hypersecreting adrenal mass, signs/symptoms of hypercortisolism;
- •already known secondary osteoporosis with the exception of hypercalciuria;
- •drugs influencing the bone metabolism with the exception of diuretics, anti-diabetics and anticoagulants;
- •conditions associated with increased hypothalamic-pituitary-adrenal (HPA) axis activity, severe autoimmune/rheumatologic and hematologic diseases, alcoholism, chronic kidney disease (glomerular filtration rate <60 ml/min);
- •drugs influencing the HPA axis activity or the dexamethasone metabolism.
结局指标
主要结局
Prevalence of hidden hypercortisolism in patients with osteoporosis or osteopenia plus the comorbidities possibly associated with cortisol excess
时间窗: 18 months
To evaluate the prevalence of hidden hypercortisolism in patients with osteoporosis or osteopenia plus the comorbidities possibly associated with cortisol excess.
次要结局
- Predictors of the presence of HidHyCo in in patients with osteoporosis or osteopenia associated with comorbidities.(18 months)