Prevalence of Hidden Hypercortisolism in Osteoporosis

NCT05762549 | Unknown

• 1 other identifier: 05L101
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Osteoporosis; Cortisol Excess

Outcome Measures

Primary Outcomes (1)

• Prevalence of hidden hypercortisolism in patients with osteoporosis or osteopenia plus the comorbidities possibly associated with cortisol excess

  To evaluate the prevalence of hidden hypercortisolism in patients with osteoporosis or osteopenia plus the comorbidities possibly associated with cortisol excess.

  18 months

Secondary Outcomes (1)

• Predictors of the presence of HidHyCo in in patients with osteoporosis or osteopenia associated with comorbidities.

  18 months

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals referred to our outpatients clinics for osteoporosis

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (5)

U.O.C. Medicina Interna, Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco"

Catania, Italy

RECRUITING

U.O.C. Endocrinologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

RECRUITING

U.O.S. Endocrinologia, Ospedale "Casa Sollievo della Sofferenza" IRCCS

San Giovanni Rotondo, Italy

RECRUITING

Dipartimento di Scienze Mediche, Chirurgiche e Neuroscienze, Azienda Ospedaliero-Universitaria Senese di Santa Maria alle Scotte

Siena, Italy

RECRUITING

S.O.C. Endocrinologia e Malattie del Metabolismo, Presidio Ospedaliero Universitario "Santa Maria della Misericordia", Azienda Sanitaria-Universitaria Friuli Centrale

Udine, Italy

RECRUITING

MeSH Terms

Conditions

Osteoporosis; ACTH Syndrome, Ectopic

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Paraneoplastic Endocrine Syndromes; Paraneoplastic Syndromes; Neoplasms

Study Officials

• Elisa Cairoli, MD

  Istituto Auxologico Italiano

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisa Cairoli, MD

CONTACT

390261911; e.cairoli@auxologico.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2023
• First Posted: March 9, 2023
• Study Start: May 26, 2022
• Primary Completion: November 30, 2023
• Study Completion: May 31, 2024
• Last Updated: March 9, 2023

Record last verified: 2023-03

Locations

IT (5)