Cushing's Osteoporosis Specificities

NCT03162068 | Completed

• 2 other identifiers: CHU-3342016-A01482-49
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Cushing's syndrome; Osteoporosis; peripheral Quantitative Computed; volumetric Bone Mineral Density; Cortical and trabecular bone; Bone Strength

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Assessment of strength bone of radius and tibia of the non-dominant limb

  at day 1

• Assessment of trabecular and cortical compartment

  at day 1

• Comparison of muscle area and surface, adipose tissue

  at day 1

Study Arms (3)

Control group

Cases are recruited thanks to advertisement within CHU.

Other: Osteodensitometry and pQCT

Post menopausal women

Post-menopausal women are recruited within rheumatology service.

Other: Osteodensitometry and pQCT

Cushing' syndrome group

Cushing' syndrome patients are recruited during hospitalisation in endocrinology service

Other: Osteodensitometry and pQCT

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.

Control group; Cushing' syndrome group; Post menopausal women

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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
• Patients unable to express their will (sub-tutelage, curators, dementia).
• Lack of social security
• Lack of follow-up
• Excessive consumption of alcohol

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Unité de recherche GReD CNRS UMR6293 / Inserm: collaborator

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63003, France

Location

MeSH Terms

Conditions

Cushing Syndrome; Osteoporosis

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Marie BATISSE-LIGNIER

  CHU de Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2017
• First Posted: May 22, 2017
• Study Start: April 4, 2017
• Primary Completion: March 13, 2025
• Study Completion: March 13, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-04

Locations

FR (1)