Clinical trial: Cushing's Osteoporosis Specificities (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
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.


Patient description (medical language): A 47-year-old man comes to the office due to weight gain and fatigue.  He is not able to lift heavy objects or climb stairs. Family history is positive for DM type 2 and HTN in his father.  Blood pressure is 165/90 mm Hg and pulse is 85/min.  On physical examination, there is symmetric proximal muscle weakness of the upper and lower extremities.  Fasting plasma glucose level is 138 mg/dL and 24-hour urinary cortisol is twice the upper normal limit.  Further evaluation reveals that high-dose, but not low-dose, dexamethasone suppresses serum cortisol levels.  Serum ACTH levels are high-normal. This patient's findings are consistent with endogenous Cushing Syndrome.

Patient description (patient's own words): I'm a 47-year-old man. I went to the clinic because I had been gaining weight and had increased fatigue over the past few weeks. I was not able to lift heavy objects or even climb the stairs. My dad was diagnosed with type 2 diabetes and high blood pressure. During the exam, they took my blood pressure, which was 165/90 mm Hg, and my pulse was 85/min. They found out that I have weaknesses in both of my arms and legs. I also did a blood test on an empty stomach, and I had a glucose level of 138 mg/dL, and twice the upper normal limit of cortisol. I had high-normal levels of ACTH. The doctor said I suffer from endogenous Cushing Syndrome.

Does the patient match the trial criteria? Entailment