Osteoporosis in Cushing's SyndromeSOCSNCT03162068
Cushing's Osteoporosis Specificities
An observational study of Osteoporosis in Cushing's Syndrome and Osteoporosis in Post-menopausal Women, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis in Cushing's Syndrome, Osteoporosis in Post-menopausal Women
- What is being tested?
- Osteodensitometry and pQCT
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 4 Apr 2017to 13 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cushing syndrome group (CS): both Menopausal women Control: both Control = 24 Post menopausal women = 24 Cushing'syndrome group : n = 12
Who may be able to join
- 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)
Show all 15Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
Read more
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.
Read the 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.
- Being tested
- Osteodensitometry and pQCT
- Keywords
- Cushing's syndrome, Osteoporosis, peripheral Quantitative Computed, volumetric Bone Mineral Density, Cortical and trabecular bone, Bone Strength
- Medical subject headings
- Cushing Syndrome, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteodensitometry and pQCTOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Cases are recruited thanks to advertisement within CHU. Receives: Other: Osteodensitometry and pQCT | |
| Post menopausal women | Post-menopausal women are recruited within rheumatology service. Receives: Other: Osteodensitometry and pQCT | |
| Cushing' syndrome group | Cushing' syndrome patients are recruited during hospitalisation in endocrinology service Receives: Other: Osteodensitometry and pQCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at day 1
Secondary outcomes (3)
Assessment of strength bone of radius and tibia of the non-dominant limb
comparison Cushing syndrome versus both menopause women and controls : pQCT analysis
Measured: at day 1
Assessment of trabecular and cortical compartment
comparison Cushing syndrome versus both menopause women and controls : pQCT analysis
Measured: at day 1
Comparison of muscle area and surface, adipose tissue
comparison Cushing syndrome versus both menopause women and controls : pQCT analysis
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start4 Apr 2017
- Primary completion13 Mar 2025
- Study completion13 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis in Cushing's SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Unité de recherche GReD CNRS UMR6293 / Inserm
- Responsible party
- Sponsor
- Investigators
- Marie BATISSE-LIGNIER, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03162068
- Sponsor's protocol ID
- CHU-334
- Other IDs
- 2016-A01482-49
- Acronym
- SOCS
- Status last verified
- Apr 2025
- First submitted
- 12 May 2017
- Last updated
- 15 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specificities of Cushing's Osteoporosis Compare to Postmenopausal Osteoporosis : pQCT Analysis in Comparison With a Group of Controls.
- ClinicalTrials.gov ID
- NCT03162068
- Acronym / sponsor ID
- SOCS / CHU-334
- Keywords
- Cushing's syndrome, Osteoporosis, peripheral Quantitative Computed, volumetric Bone Mineral Density, Cortical and trabecular bone, Bone Strength
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Unité de recherche GReD CNRS UMR6293 / Inserm
- Study start
- 4 Apr 2017 (actual)
- Primary completion
- 13 Mar 2025 (actual)
- Study completion
- 13 Mar 2025 (actual)
- First posted
- 22 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Other: Osteodensitometry and pQCTCases are recruited thanks to advertisement within CHU. |
| Post menopausal women | – | Other: Osteodensitometry and pQCTPost-menopausal women are recruited within rheumatology service. |
| Cushing' syndrome group | – | Other: Osteodensitometry and pQCTCushing' syndrome patients are recruited during hospitalisation in endocrinology service |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cushing syndrome group (CS): both Menopausal women Control: both Control = 24 Post menopausal women = 24 Cushing'syndrome group : n = 12
Key inclusion criteria (15 listed)
- Cases
- Postmenopausal women
- Cushing's syndrome
Key exclusion criteria (12 listed)
- Diseases with bone resonance:
- Treatments:
- Other:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteodensitometry and pQCTThe 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. | Other | Control group, Cushing' syndrome group, Post menopausal women |
Primary outcome
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
3 secondary outcomes
Assessment of strength bone of radius and tibia of the non-dominant limb
Time frame: at day 1
Assessment of trabecular and cortical compartment
Time frame: at day 1
Comparison of muscle area and surface, adipose tissue
Time frame: at day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
Related trials for Osteoporosis in Cushing's Syndrome
Recruiting
REMS25: Study on the Use of REMS Technology in Diseases Commonly Associated With Reduced Bone Mineral Density (BMD)
Osteogenesis Imperfecta, Osteoporosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie BATISSE-LIGNIER principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis in Cushing's Syndrome and Osteoporosis in Post-menopausal Women, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of volumetric bone mineral density (time frame: at day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.