Osteoporosis in Post-menopausal Women Clinical Trial
— SOCSOfficial 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.
| Status | Recruiting |
| Enrollment | 60 |
| Est. completion date | May 2024 |
| Est. primary completion date | May 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU Clermont-Ferrand | Clermont-Ferrand | Auvergne |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Clermont-Ferrand | Unité de recherche GReD CNRS UMR6293 / Inserm |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Comparison of volumetric bone mineral density | thanks to pQCT with evaluation of total, trabecular and cortical compartment, between patients affecting by cushing'syndrome and post-menopausal women | at day 1 | |
| Secondary | Assessment of strength bone of radius and tibia of the non-dominant limb | comparison Cushing syndrome versus both menopause women and controls : pQCT analysis | at day 1 | |
| Secondary | Assessment of trabecular and cortical compartment | comparison Cushing syndrome versus both menopause women and controls : pQCT analysis | at day 1 | |
| Secondary | Comparison of muscle area and surface, adipose tissue | comparison Cushing syndrome versus both menopause women and controls : pQCT analysis | at day 1 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01415050 -
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Phase 2 |