Last reviewed · How we verify
NCT05762549: OSTCOR
Prevalence of Hidden Hypercortisolism in Osteoporosis
trial in Osteoporosis in 1,000 participants. Status unknown.
30 November 2023
Quick facts
| Lead sponsor | Istituto Auxologico Italiano |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 1,000 |
| Start date | 26 May 2022 |
| Primary completion | 30 November 2023 |
| Estimated completion | 31 May 2024 |
| Sites | 5 locations across Italy |
Conditions studied
- Osteoporosis — all drugs for Osteoporosis →
- Cortisol Excess — all drugs for Cortisol Excess →
Sponsor
Istituto Auxologico Italiano — full company profile →
Who can join
Adults 18 to 75, any sex, with Osteoporosis or Cortisol Excess. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05762549
- Europe PMC full search
- ASCO Meeting Library
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05762549 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Istituto Auxologico Italiano
- Last refreshed: 9 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05762549.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing