Parathyroid removal to improve mobility in older adults

Rescuing Mobility Function Through Surgical Removal of the Parathyroid Gland

This project will see if removing an overactive parathyroid gland helps adults aged 60+ with primary hyperparathyroidism regain strength, move better, and be more active.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Ages: 60 Years to 100 Years
• Sex: All
• Sponsor: University of Florida (Academic / other)
• Drugs / interventions: denosumab, romosozumab
• Locations: 1 site (Gainesville, Florida)
• Trial ID: NCT07103876 on ClinicalTrials.gov

What this trial studies

This is a prospective observational study enrolling up to 80 adults aged 60 and older who are undergoing parathyroidectomy at UF Health. Participants will complete standardized physical performance tests, wear an Actigraph device to measure real-world physical activity, and provide blood samples for inflammatory and other biomarker analysis at pre- and post-operative time points. The study will characterize changes in physical function and activity after surgery and look for biomarkers that predict who improves. Results are intended to inform larger trials and could influence surgical decision-making for older adults with primary hyperparathyroidism.

Who should consider this trial

Good fit: Ideal candidates are adults aged 60 or older with biochemically confirmed hypercalcemic primary hyperparathyroidism who plan to undergo parathyroidectomy at UF Health and can give informed consent.

Not a fit: Patients with eucalcemic primary hyperparathyroidism, those not having surgery at UF Health, or those with recent major surgery, recent fractures, or recent immobilizing orthopedic trauma are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, the findings could show that parathyroidectomy improves strength and mobility in older adults and help expand surgical recommendations for some patients with primary hyperparathyroidism.

How similar studies have performed: Prior smaller studies have reported improvements in quality of life and some measures of function after parathyroidectomy, but mobility-specific outcomes and biomarker predictors in older adults remain limited and under-studied.

Eligibility 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.

Where this trial is running

Gainesville, Florida

• Clinical and Translational Research Building — Gainesville, Florida, United States (Recruiting)

Study contacts

• Study coordinator: Nevena Stanojevic, Bachelor of Science

Conditions Hyperparathyroidism; Parathyroid; Mobility; Physical Function; Inflammatory Biomarkers; Parathyroidectomy; Aging; Physical activity