Osteoporosis in Post-menopausal Women Clinical Trial
Official title:
Specificities of Cushing's Osteoporosis Compare to Postmenopausal Osteoporosis : pQCT Analysis in Comparison With a Group of Controls.
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.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01415050 -
Safety and Efficacy of Whole-body Vibration as add-on Treatment of Osteoporosis in Post-menopausal Women
|
Phase 2 |