Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-24 @ 5:37 PM
NCT ID:
NCT03162068
Eligibility Criteria:
Inclusion Criteria:
1. Cases
* Healthy Volunteers
* Men and women\> 18 years
* No known chronic treatment or pathology
* Absence of tobacco or alcohol
* Normal bone mineral density for age (Z-score\> -2 and T-score\> -2.5) and markers of bone remodeling in normal values for age and menopausal status (osteocalcin, CTX)
* Free 24-hour urinary cortisol (CLU / 24 h) normal Cushing matching by menopausal status, age group, BMI, sex
2. Postmenopausal women
* Menopause confirmed by hormonal assays
* Amenorrhea for more than one year
* Free 24-hour urinary cortisol (CLU / 24 h) normal
* Osteoporosis confirmed at DXA (T score ≤ -2.5 DS) Post menopausal women matching according to BMI, T-DXA score (T score ≤ -2.5 DS)
3. Cushing's syndrome
* Endogenous hypercorticism, whatever the cause (dependent or independent ACTH)
* Active or controlled for less than 5 years
Exclusion Criteria:
1. Diseases with bone resonance:
* Disease that can affect phosphocalcium metabolism or promote bone loss: endocrine diseases (hyperparathyroidism, hyperthyroidism); Osteomalacia, malabsorptive intestinal or inflammatory or chronic liver diseases, chronic inflammatory rheumatism.
* Heavy comorbidities: heart failure or chronic respiratory insufficiency, known severe renal insufficiency.
2. Treatments:
* Anti-osteoporotic treatments (bisphosphonates, raloxifene, denosumab)
* Teriparatide; Lithium, thiazide diuretic, treatment with levothyrox suppressive dose, hormone replacement therapy of menopause, anticonvulsants, corticotherapy in progress or in the previous 5 years, anti-aromatases, anti-androgenic
3. Other:
* Minors, pregnant women
* Patients unable to express their will (sub-tutelage, curators, dementia).
* Lack of social security
* Lack of follow-up
* Excessive consumption of alcohol
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03162068
Study Brief:
Protocol Section:
NCT03162068