Purpose

This study evaluates whether surgical removal of the parathyroid gland (parathyroidectomy) improves physical function and mobility in older adults with primary hyperparathyroidism (PHPT). PHPT, a common endocrine disorder in older adults, is associated with reduced muscle strength, mobility, and quality of life. This prospective observational study will enroll up to 80 participants aged 60 and older undergoing parathyroidectomy at UF Health. Participants will complete physical performance tests, wear an Actigraph device to assess physical activity, and provide blood samples for biomarker analysis at pre- and post-operative time points. The goal is to characterize changes in physical function and activity following surgery and to identify biomarkers that may predict mobility improvements. Findings will help inform future larger-scale studies and could expand surgical indications for PHPT in older adults.

Conditions

Eligibility

Eligible Ages
Between 60 Years and 100 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Criteria

Inclusion:

- Age ≥ 60 years;

- Biochemical diagnosis of hypercalcemic (corrected serum calcium >10.2 mg/dL or
ionized serum calcium >1.31 mmol/dL or 5.2 mg/dL on at least one serum sample)
primary hyperparathyroidism as determined by board-certified endocrinologist or
endocrine surgeon;

- Undergoing parathyroidectomy at UF Health;

- Willing and able to give informed consent.

Exclusion:

- Failure to provide informed consent;

- Biochemical diagnosis of eucalcemic primary hyperparathyroidism (corrected serum
calcium ≤10.2 mg/dL or ionized serum calcium ≤1.31 mmol/dL or 5.2 mg/dL on at least
one serum sample);

- Elected not to undergo parathyroidectomy at UF Health;

- Major surgery as deemed by principal investigator or hip/knee replacement in the
past 6 months;

- Fractures to the hands, arms or legs within the last 6 months;

- Traumatic accident (i.e. motor vehicle collision, fall from elevation, etc.)
resulting in orthopedic trauma or requiring prolonged immobilization (>2 weeks)
within the last 6 months;

- Blood transfusion within the past 3 months;

- Self-reported myocardial infarction, cerebrovascular accident, or unstable angina
within the past 6 months;

- NYHA Class 3 or 4 congestive heart failure;

- Major psychiatric disorder;

- Cancer requiring treatment in the past 1 year (including metastatic cancer), except
for locally treated non-melanoma skin cancers or cancers that have clearly been
cured or in the opinion of the investigator carry an excellent prognosis (e.g.,
Stage 1 cervical cancer);

- Renal failure requiring hemodialysis or peritoneal dialysis

- Use of bone-modifying therapies (alendronate [Fosamax], zoledronic acid [Reclast],
denosumab [Prolia or Xgeva], or romosozumab [Evenity]) within 1 month of planned
surgery

- Planning to permanently leave the area within 3 months of parathyroidectomy;

- Vision or hearing impairment - defined as unable to read or listen/follow
instructions despite the use of maximal assistive devices (i.e. contact lenses,
glasses, hearing aids, etc.)

- Participating in another clinical trial or has received an investigational product
within 30 days prior to screening/enrollment.

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Adults aged 60 and above with primary hyperparathyroidism Participants who are undergoing a parathyroidectomy at UF health

Recruiting Locations

Clinical and Translational Research Building
Gainesville, Florida 32610
Contact:
Recruitment Coordinators
352-273-5919
recruit@aging.ufl.edu

More Details

Status
Recruiting
Sponsor
University of Florida

Study Contact

Rezvan Ghaderpanah, MD
352-273-5919
ghaderpanah.r@ufl.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.