HyperparathyroidismNCT07103876
Parathyroidectomy and Mobility Study
An observational study of Hyperparathyroidism and Parathyroid, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Hyperparathyroidism, Parathyroid, Mobility
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2025to 31 Mar 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Clinical and Translational Research Building
Gainesville, Florida, 32610
Recruitment Coordinators, 352-273-5919, recruit@aging.ufl.edu
About this study
Official title: Rescuing Mobility Function Through Surgical Removal of the Parathyroid Gland
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
- Medical subject headings
- Hyperparathyroidism, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults aged 60 and above with primary hyperparathyroidism | Participants who are undergoing a parathyroidectomy at UF health |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start15 Aug 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07103876
- Sponsor's protocol ID
- IRB202500602
- Other IDs
- P30AG028740
- Status last verified
- Sep 2026
- First submitted
- 21 Jul 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rescuing Mobility Function Through Surgical Removal of the Parathyroid Gland
- ClinicalTrials.gov ID
- NCT07103876
- Acronym / sponsor ID
- IRB202500602
- Conditions
- Hyperparathyroidism, Parathyroid, Mobility
- Keywords
- Physical Function, Inflammatory Biomarkers, Parathyroidectomy, Aging, Physical activity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults aged 60 and above with primary hyperparathyroidism | – | –Participants who are undergoing a parathyroidectomy at UF health |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperparathyroidism and Parathyroid, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rezvan Ghaderpanah, MD (352-273-5919, ghaderpanah.r@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance Walked in Six-Minute Walk Test (6MWT) (time frame: At pre-operative assessment and at 3 month post-operative assessment). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.