PATHophysiology of OSteoporosis: Role of Hidden Cortisol Excess and Its Predictors in Bone Fragility

Launched by ISTITUTO AUXOLOGICO ITALIANO · Mar 15, 2024

Keywords

ClinConnect Summary

This clinical trial, titled "PATHophysiology of OSteoporosis: Role of Hidden Cortisol Excess and Its Predictors in Bone Fragility," is studying how a hidden form of excess cortisol, a hormone, may affect bone health in people with osteoporosis. Osteoporosis is a condition that weakens bones and increases the risk of fractures. The trial aims to find out how common this hidden cortisol excess is among patients with osteoporosis and to understand its effects on bone quality. Researchers will compare the health characteristics of patients with and without this condition to identify those who might benefit most from further testing.

To participate, individuals must be between 65 and 74 years old and have either osteoporosis, which is diagnosed through specific bone density tests or fragility fractures, or osteopenia with certain health issues like high blood pressure or diabetes. Participants can expect to undergo health assessments and tests related to their bone health and cortisol levels. It's important to note that this study is currently recruiting participants and is focused on understanding how hidden cortisol excess may be linked to bone fragility, which could lead to better treatments for osteoporosis in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria (one of the following):
• • 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).
• Exclusion Criteria:
• • 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.