| NCT ID | NCT07103876 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Florida |
| Condition | Hyperparathyroidism |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-08-15 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2025-08-15 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07103876 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, up to 100 Years, studying Hyperparathyroidism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07103876 currently recruiting?
Yes, NCT07103876 is actively recruiting participants. Contact the research team at nevenastanojevic@ufl.edu for enrollment information.
Where is the NCT07103876 trial being conducted?
This trial is being conducted at Gainesville, United States.
Who is sponsoring the NCT07103876 clinical trial?
NCT07103876 is sponsored by University of Florida. The trial plans to enroll 80 participants.