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Completed

NCT Number: NCT04343560

MACS and Healthy Volunteers Bone Study

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.

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Key information

Conditions

MACS Syndrome Macrocephaly, Alopecia, Cutis Laxa, and Scoliosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. BV/TV ratio

    Time frame: 0-24 months

    measured by computed tomography

  2. steroid metabolome

    Time frame: 0-24 months

    24h urine steroid profiling

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Effects of Abnormal Steroid Metabolome on Bone Strength and Quality, Bone Density, Bone Remodeling, and Body Composition in Patients With MACS and Healthy Volunteers.

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Apr 13, 2020
Registry last updated
Dec 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.