Understanding the role of hidden cortisol excess in osteoporosis and bone fragility

Pathophysiology of Osteoporosis: Role of Hidden Cortisol Excess and Its Predictors in Bone Fragility (PNRR-MAD-2022-12375951)

This study looks at whether hidden high cortisol levels are common in people with osteoporosis and how they might affect bone strength and fracture risk.

Quick facts

• Study type: Observational
• Enrollment: 1500 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Istituto Auxologico Italiano (Academic / other)
• Drugs / interventions: denosumab
• Locations: 5 sites (Catania and 4 other locations)
• Trial ID: NCT06324084 on ClinicalTrials.gov

What this trial studies

This observational study investigates the prevalence of hidden hypercortisolism (HidHyCo) in patients with osteoporosis and its association with bone fragility. It aims to identify characteristics of osteoporosis that may be linked to HidHyCo, which is often asymptomatic but can increase the risk of fractures. The study will analyze data from patients with osteoporosis or osteopenia, particularly those with additional health complications like hypertension or diabetes. By understanding these relationships, the study seeks to improve detection and management of osteoporosis in affected individuals.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with osteoporosis or osteopenia who also have hypertension or diabetes.

Not a fit: Patients with known secondary osteoporosis or those exhibiting signs of hypercortisolism may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better identification and management of osteoporosis patients at risk for hidden cortisol excess, potentially reducing fracture rates.

How similar studies have performed: While the concept of hidden hypercortisolism is relatively novel, there is emerging evidence suggesting its significance in osteoporosis, indicating potential for impactful findings.

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.

Where this trial is running

Catania and 4 other locations

• Azienda Ospedaliera Universitaria Policlinico "G. Rodolico-San Marco" — Catania, Italy (Not_yet_recruiting)
• Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan, Italy (Recruiting)
• Istituto Auxologico Italiano IRCCS — Milan, Italy (Recruiting)
• Ospedale "Casa Sollievo della Sofferenza" IRCCS — San Giovanni Rotondo, Italy (Recruiting)
• Azienda Ospedaliera Universitaria Senese — Siena, Italy (Not_yet_recruiting)

Study contacts

• Principal investigator: Iacopo Chiodini, Professor — ASST Ospedale Niguarda, Milan, Italy
• Study coordinator: Elisa Cairoli, MD PhD

Conditions Osteoporosis; Bone Fracture; Cortisol Excess; Cortisol