Parathyroidectomy and Mobility Study

NCT07103876 | Recruiting DMC

• 2 other identifiers: IRB202500602P30AG028740
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Hyperparathyroidism; Parathyroid; Mobility

Keywords

Physical Function; Inflammatory Biomarkers; Parathyroidectomy; Aging; Physical activity

Outcome Measures

Primary Outcomes (10)

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

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

  At pre-operative assessment and at 3 month post-operative assessment

• Short Physical Performance Battery Score

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

  At pre-operative assessment and at 3 month post-operative assessment

• Isokinetic Knee Strength (Biodex)

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

  At pre-operative assessment and at 3 month post-operative assessment

• Grip Strength

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

  At pre-operative assessment and at 3 month post-operative assessment

• Intensity of Movement using ActiGraph Accelerometry

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

  At pre-operative assessment and at 3 month post-operative assessment

• Frequency of Movement using ActiGraph Accelerometry

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

  At pre-operative assessment and at 3 month post-operative assessment

• Duration of Movement using ActiGraph Accelerometry

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

  At pre-operative assessment and at 3 month post-operative assessment

• CHAMPS Questionnaire Score

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

  At pre-operative assessment and at 3 month post-operative assessment

• Pasieka Parathyroidectomy Assessment of Symptoms (PAS)

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

  At pre-operative assessment and at 3 month post-operative assessment

• Concentration of Plasma Cytokine Biomarkers

  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.

  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

Study Arms (1)

Adults aged 60 and above with primary hyperparathyroidism

Participants who are undergoing a parathyroidectomy at UF health

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will enroll adults aged 60 years and older with a confirmed biochemical diagnosis of hypercalcemic primary hyperparathyroidism (PHPT) who are scheduled to undergo parathyroidectomy at UF Health. Eligible participants must be able and willing to provide informed consent and complete all study procedures, including pre- and post-operative physical assessments and blood draws.

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Clinical and Translational Research Building

Gainesville, Florida, 32610, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be collected for plasma biomarker analysis (e.g., myokines, osteokines, and adipokines such as IL-6, myostatin, and FGF-21), as well as for standard clinical labs including calcium, parathyroid hormone (PTH), and vitamin D.

MeSH Terms

Conditions

Hyperparathyroidism; Motor Activity

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases; Behavior

Central Study Contacts

Nevena Stanojevic, Bachelor of Science

CONTACT

352-273-5919; nevenastanojevic@ufl.edu

Aditya Shirali, MD

CONTACT

352-265-0169; aditya.shirali@surgery.ufl.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: August 5, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: September 29, 2025

Record last verified: 2025-07

Locations

US (1)