ClinicalTrials.gg
RecruitingNCT07103876Updated Sep 15, 2026

Parathyroidectomy and Mobility Study

An observational study in Hyperparathyroidism, Parathyroid and Mobility, sponsored by University of Florida. Recruiting at 1 site in United States. Open to participants aged 60 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by University of Florida · Observational

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
60 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hyperparathyroidism
  • Parathyroid
  • Mobility

Keywords

  • Physical Function
  • Inflammatory Biomarkers
  • Parathyroidectomy
  • Aging
  • Physical activity
03

In context

Hyperparathyroidism

110 studies on the registry are indexed under Hyperparathyroidism; 12 are open to participants now.

This study's planned enrollment of 80 is below the median of 99 across 37 observational studies indexed under Hyperparathyroidism.

Browse Hyperparathyroidism studies →

Lead sponsor

University of Florida is the lead sponsor of 1,287 studies on the registry; 199 are open to participants now.

Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 .

Exclusion criteria

Exclusion:

  • Failure to provide ;
  • 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;
  • Class 3 or 4 congestive heart failure;
  • Major psychiatric disorder;
  • Cancer requiring treatment in the past 1 year (including 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 product within 30 days prior to screening/enrollment.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • Adults aged 60 and above with primary hyperparathyroidism

    Participants who are undergoing a parathyroidectomy at UF health

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

  3. Isokinetic Knee Strength (Biodex)

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

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

  4. Grip Strength

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

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

  8. CHAMPS Questionnaire Score

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

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

  9. 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.

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

  10. 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.

    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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2025 (actual). Primary completion is estimated for Mar 2027, 18 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 21, 2025
First posted
Aug 5, 2025
StartActual
Aug 15, 2025
Primary completionEst.
Mar 1, 2027
CompletionEst.
Mar 31, 2027
Last update
Sep 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07103876
Responsible party
Sponsor
First posted
Aug 5, 2025
Start date
Aug 15, 2025
Primary completion
Mar 1, 2027 (estimated)
Completion
Mar 31, 2027 (estimated)
Last update
Sep 15, 2026

Study contacts

Rezvan Ghaderpanah, MD
Contact
ghaderpanah.r@ufl.edu
352-273-5919
Aditya Shirali, MD
Contact
aditya.shirali@surgery.ufl.edu
352-265-0169

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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