Cushing's Osteoporosis Specificities

What this trial studies

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).

Conditions in scope

• Osteoporosis in Cushing's Syndrome
• Osteoporosis in Post-menopausal Women

Interventions

• Osteodensitometry and pQCT (Other) — 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.

Who can join

All sexes · Ages 18 Years and up · Accepts healthy volunteers.

Inclusion criteria

• 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

Exclusion criteria

• 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.
• 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:
• Minors, pregnant women

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Observational
• Phase: N/A
• Start date: 2017-04-04
• Primary completion: 2025-03-13
• Last update posted: 2025-04-15
• First posted: 2017-05-22

Sponsor & contact

Lead sponsor: University Hospital, Clermont-Ferrand (Other)

Collaborators: Unité de recherche GReD CNRS UMR6293 / Inserm

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Comparison of volumetric bone mineral density (at day 1)
  thanks to pQCT with evaluation of total, trabecular and cortical compartment, between patients affecting by cushing'syndrome and post-menopausal women

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