NCT03162068Completed
Cushing's Osteoporosis Specificities
Specificities of Cushing's Osteoporosis Compare to Postmenopausal Osteoporosis : pQCT Analysis in Comparison With a Group of Controls.
Source: ClinicalTrials.gov · Last updated 15 Apr 2025
Brief summary (registry, in English)
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 (registry)
- Completed
- Study type
- Observational
- Enrollment
- 50 (actual)
- First submitted
- 12 May 2017
- Start date
- 4 Apr 2017
- Primary completion date
- 13 Mar 2025
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Diseases
- Osteoporosis
- NCT number
- NCT03162068
What you commit to
- Study type: Observational
- Participants enrolled: 50
- From 4 Apr 2017 to the primary completion date, 13 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 illness
- 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.
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.