Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-26 @ 4:59 AM
Study NCT ID:
NCT03162068
Status:
COMPLETED
Last Update Posted:
2025-04-15
First Post:
2017-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cushing's Osteoporosis Specificities
Sponsor:
University Hospital, Clermont-Ferrand
Organization:
Study Overview
Official Title:
Specificities of Cushing's Osteoporosis Compare to Postmenopausal Osteoporosis : pQCT Analysis in Comparison With a Group of Controls.
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOCS
Brief 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.
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.
Detailed 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.
\- 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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2016-A01482-49 | OTHER | 2016-A01482-49 | View |