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MACS and Healthy Volunteers Bone Study

NCT ID: NCT04343560

Last Updated: 2023-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

380 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-21

Study Completion Date

2023-12-11

Brief Summary

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Adrenal adenoma is detected in 5-7% of adults and demonstrates mild autonomous cortisol secretion (MACS, dexamethasone suppression test \>1.8 mcg/dl) in 50% of individuals with adenoma. Published reports suggest a 48%-52% 2-year incidence of new vertebral fractures in patients with MACS without any significant changes in bone density measurements. A disproportionate decrease in bone quality versus density or other factors such as sarcopenia potentially contribute to development of new vertebral fractures. Determining which specific abnormalities in the steroid metabolome affect bone density, quality and strength as well as bone remodeling markers and body composition will potentially serve as a diagnostic biomarker of clinical significance.

Detailed Description

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In this study, we will determine whether patients with MACS (versus healthy age and sex matched controls) demonstrate: 1) decreased bone strength and quality disproportionate to the decrease of bone density and 2) abnormalities in the steroid metabolome correlate with the degree of abnormalities in bone parameters. In a cross-sectional study of 75 patients with MACS and 75 age- and sex-matched healthy controls, we will determine the relationship of the steroid metabolome to measurements of bone density, quality and strength, bone turnover markers, as well as body composition. All patients will be interviewed in regards to their health, to include questions on bone health, frailty, cognition (NIH toolbox), and quality of life. We will measure 1) BMD (bone mineral density) at the lumbar spine, hip and radius and body composition using dual-energy X ray absorptiometry (DXA), 2) radial and tibial bone microstructure by high-resolution peripheral quantitative computed tomography (HR-pQCT), 4) bone turnover markers (osteocalcin, PINP, CTx, sclerostin). 5) Age reader measurement, 6) hand grip measurement, 7) 6 minute walk test. All patients will provide a 24 h urine for steroid metabolome analysis. For primary outcomes, we will determine if steroid metabolome profiling better predicts abnormal bone strength (as measured by trabecular bone volume/tissue volume \[BV/TV\] ratio).

Conditions

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MACS Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients with MACS

Patients with adrenal adenoma and dexamethasone suppression test \>1.8 mcg/dl

No interventions assigned to this group

healthy controls

no history of adrenal and pituitary disease, no exogenous steroids

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients with MACS
* Age 18-no maximum
* exogenous steroids therapy within the last 5 years ( for more than 3 months , prednisone equivalent \>7.5 mg daily)
* steroid hormone replacement therapy
* any drug therapy affecting bone metabolism
* recent fracture

Exclusion Criteria

* exogenous steroids therapy within the last 5 years ( for more than 3 months , prednisone equivalent \>7.5 mg daily)
* steroid hormone replacement therapy ( for adrenal insufficiency, hypogonadism, menopause)
* therapy for osteoporosis
* any drug therapy affecting bone metabolism
* comorbidities affecting steroid metabolome or bone metabolism
* recent fracture
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Irina Bancos

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Irina Bancos, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

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18-009787

Identifier Type: -

Identifier Source: org_study_id