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NCT Number: NCT07103876

Parathyroidectomy and Mobility Study

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.

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Key information

Conditions

Hyperparathyroidism Behavior Endocrine System Diseases Mobility Motor Activity Parathyroid Parathyroid Diseases

Age range

60 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical and Translational Research Building

Gainesville, Florida, 32610, United States

Location status: Recruiting

Location contact

Recruitment Coordinators

CONTACT

[email protected]

352-273-5919

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. Distance Walked in Six-Minute Walk Test (6MWT)

    Time frame: At pre-operative assessment and at 3 month post-operative assessment

    Measures walking endurance and aerobic capacity by recording the distance walked in six minutes along a 20-meter course.

  2. Short Physical Performance Battery Score

    Time frame: At pre-operative assessment and at 3 month post-operative assessment

    A composite test assessing balance, gait speed (4-meter walk), and lower body strength (chair stands). Higher scores reflect better function.

  3. Isokinetic Knee Strength (Biodex)

    Time frame: At pre-operative assessment and at 3 month post-operative assessment

    Assesses lower limb muscle strength and endurance using a dynamometer. Reports peak torque and fatigue index.

  4. Grip Strength

    Time frame: At pre-operative assessment and at 3 month post-operative assessment

    Handgrip strength is measured using a dynamometer as a marker of overall muscle strength and frailty risk.

  5. Intensity of Movement using ActiGraph Accelerometry

    Time frame: At pre-operative assessment and at 3 month post-operative assessment

    An objective measure of free-living physical activity using a wearable hip device that captures intensity of movement over 7 days.

  6. Frequency of Movement using ActiGraph Accelerometry

    Time frame: At pre-operative assessment and at 3 month post-operative assessment

    An objective measure of free-living physical activity using a wearable hip device that captures frequency of movement over 7 days.

  7. Duration of Movement using ActiGraph Accelerometry

    Time frame: At pre-operative assessment and at 3 month post-operative assessment

    An objective measure of free-living physical activity using a wearable hip device that captures duration of movement over 7 days.

  8. CHAMPS Questionnaire Score

    Time frame: At pre-operative assessment and at 3 month post-operative assessment

    A validated self-report tool for older adults that measures weekly frequency and duration of common physical activities.

  9. Pasieka Parathyroidectomy Assessment of Symptoms (PAS)

    Time frame: At pre-operative assessment and at 3 month post-operative assessment

    A validated 13-item questionnaire measuring severity of neurocognitive and neuromuscular symptoms common in PHPT, such as fatigue, irritability, and memory loss.

  10. Concentration of Plasma Cytokine Biomarkers

    Time frame: Blood work will be collected at the pre-operative assessment, the 2 week post-operative assessment, 3 month post-operative assessment and the 6 month post-operative assessment

    Blood-based analysis of myokines (e.g., IL-6, myostatin, LIF, irisin), osteokines (e.g., IGF-1, FGF-21, osteocalcin), and adipokines (e.g., adiponectin, TNF-α) associated with muscle-organ crosstalk, inflammation, and mobility.

Study contacts

Contact information is provided by the study sponsor or research team.

Aditya Shirali, MD

CONTACT

[email protected]

352-265-0169

Nevena Stanojevic, Bachelor of Science

CONTACT

[email protected]

352-273-5919

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Rescuing Mobility Function Through Surgical Removal of the Parathyroid Gland

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 5, 2025
Registry last updated
Sep 29, 2025

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.

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