Parathyroidectomy and Mobility Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60-100
SponsorUniversity of Florida
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
80 Participants
are grouped into 1 trial groupGroup A: Adults aged 60 and above with primary hyperparathyroidism
Trial outcomes
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 assessment2
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 assessment3
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 assessment4
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 assessmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Florida
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov