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Trial record 11 of 844 for:    osteoporosis AND (woman OR women OR female)

Cushing's Osteoporosis Specificities (SOCS)

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ClinicalTrials.gov Identifier: NCT03162068
Recruitment Status : Recruiting
First Posted : May 22, 2017
Last Update Posted : May 22, 2017
Sponsor:
Collaborator:
Unité de recherche GReD CNRS UMR6293 / Inserm
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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.


Condition or disease Intervention/treatment
Osteoporosis in Cushing's Syndrome Osteoporosis in Post-menopausal Women Other: Osteodensitometry and pQCT

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.


Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Specificities of Cushing's Osteoporosis Compare to Postmenopausal Osteoporosis : pQCT Analysis in Comparison With a Group of Controls.
Actual Study Start Date : April 4, 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2024


Group/Cohort Intervention/treatment
Control group
Cases are recruited thanks to advertisement within CHU.
Other: Osteodensitometry and pQCT
The peripheral Quantitative Computed analyses the bone architecture with distinction between cortical and trabecular compartment. We aim to determine the specificity of osteoporosis induced by glucocorticoids excess in comparison to post menopausal osteoporosis thanks to pQCT analysis.

Post menopausal women
Post-menopausal women are recruited within rheumatology service.
Other: Osteodensitometry and pQCT
The peripheral Quantitative Computed analyses the bone architecture with distinction between cortical and trabecular compartment. We aim to determine the specificity of osteoporosis induced by glucocorticoids excess in comparison to post menopausal osteoporosis thanks to pQCT analysis.

Cushing' syndrome group
Cushing' syndrome patients are recruited during hospitalisation in endocrinology service
Other: Osteodensitometry and pQCT
The peripheral Quantitative Computed analyses the bone architecture with distinction between cortical and trabecular compartment. We aim to determine the specificity of osteoporosis induced by glucocorticoids excess in comparison to post menopausal osteoporosis thanks to pQCT analysis.




Primary Outcome Measures :
  1. Comparison of volumetric bone mineral density [ Time Frame: at day 1 ]
    thanks to pQCT with evaluation of total, trabecular and cortical compartment, between patients affecting by cushing'syndrome and post-menopausal women


Secondary Outcome Measures :
  1. Assessment of strength bone of radius and tibia of the non-dominant limb [ Time Frame: at day 1 ]
    comparison Cushing syndrome versus both menopause women and controls : pQCT analysis

  2. Assessment of trabecular and cortical compartment [ Time Frame: at day 1 ]
    comparison Cushing syndrome versus both menopause women and controls : pQCT analysis

  3. Comparison of muscle area and surface, adipose tissue [ Time Frame: at day 1 ]
    comparison Cushing syndrome versus both menopause women and controls : pQCT analysis



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Cushing syndrome group (CS): both Menopausal women Control: both

Control = 24 Post menopausal women = 24 Cushing'syndrome group : n = 12

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03162068


Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr
Contact: Marie BATISSE-LIGNIER 04 73 75 15 29 mbatisse@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, Auvergne, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Contact: Marie BATISSE-LIGNIER    04 73 75 15 29    mbatisse@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Unité de recherche GReD CNRS UMR6293 / Inserm

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03162068     History of Changes
Other Study ID Numbers: CHU-334
2016-A01482-49 ( Other Identifier: 2016-A01482-49 )
First Posted: May 22, 2017    Key Record Dates
Last Update Posted: May 22, 2017
Last Verified: May 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Clermont-Ferrand:
Cushing's syndrome
Osteoporosis
peripheral Quantitative Computed
volumetric Bone Mineral Density
Cortical and trabecular bone
Bone Strength

Additional relevant MeSH terms:
Osteoporosis
Cushing Syndrome
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases