Cushing's Osteoporosis Specificities (SOCS)

  • STATUS
    Recruiting
  • End date
    May 21, 2024
  • participants needed
    60
  • sponsor
    University Hospital, Clermont-Ferrand
Updated on 25 February 2022
Accepts healthy volunteers

Summary

Osteoporosis induced by glucocorticoids excess constitutes the main cause of secondary osteoporosis. Most of data available are provided from cohort studies of patients treated by corticosteroids, affecting among 1% of population. In contrast, very few data on osteoporosis are available in the Cushing syndrome (CS), a rare disease affecting 1 or 2 million of inhabitants, and characterized by an endogen glucocorticoid excess production. This affection is responsable of frequent fractures, occuring in 30-60% of patients (vertebral asymptomatic in 50% of case, hip, ribs). Fractures occurs often frequently above the threshold usually used for osteoporosis (T-score<-2.5), most often in the range of osteopenia. These data suggest that surface bone density isn't sufficient to characterize bone fragility, architectural factors are probably involved, and should be evaluated. The specificity of osteoporosis induced by endogen glucocorticoids excess in comparison with osteoporosis induced by estrogenic deficiency in post-menopausal women is poorly known, especially in endogen glucocorticoid excess.

A recent microarchitecture studies showed alterations of cortical compartment in patients with Cushing's syndrome, confirming by our preliminary preclinical data from a transgenic murin model of Cushing's syndrome.

In these ten last years, new radiologic tools have been developped, and are able to evaluate bone architecture. The peripheral Quantitative Computed analyses the bone architecture with distinction between cortical and trabecular compartment.

Therefore, we aim to determine the specificity of osteoporosis induced by glucocorticoids excess in comparison to post menopausal osteoporosis thanks to pQCT analysis.

Description

This study are divided in two parts :

  • Cross sectional cohort with both comparison between : Cushing syndrome versus control and cushing syndrome versus post-menopausal women

Outcomes :

Primary outcomes : Analysis thanks to pQCT will be carried out in order to compare radius and tibia bone mineral volume (total, trabecular and cortical)

Secondary outcomes :

Strength parameters, muscle area adipose tissue surface will be assessed. Analysis of body composition thanks to DXA (Dual Energy X ray Absorptiometry), and surface bone mineral density.

Evaluation of Vertebral Fracture Assesment

  • Prospective cohort with a longitudinal follow up on 5 years to assess the evolution of osteoporosis after treatment of Cushing syndrome (surgery or medical treatment).

CS patients are recruited during hospitalisation in endocrinology service Post-menopausal women are recruited within rheumatology service. Cases are recruited thanks to advertisement within CHU.

Details
Condition Osteoporosis in Cushing's Syndrome, Osteoporosis in Post-menopausal Women
Treatment Osteodensitometry and pQCT
Clinical Study IdentifierNCT03162068
SponsorUniversity Hospital, Clermont-Ferrand
Last Modified on25 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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)
Cushing's syndrome
Endogenous hypercorticism, whatever the cause (dependent or independent ACTH)
Active or controlled for less than 5 years

Exclusion Criteria

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
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
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
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