Parathyroidectomy and Mobility Study

Официальное название

Rescuing Mobility Function Through Surgical Removal of the Parathyroid Gland

Обзор

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.

Первичные конечные точки

• Distance Walked in Six-Minute Walk Test (6MWT) [Срок оценки: At pre-operative assessment and at 3 month post-operative assessment]
• Short Physical Performance Battery Score [Срок оценки: At pre-operative assessment and at 3 month post-operative assessment]
• Isokinetic Knee Strength (Biodex) [Срок оценки: At pre-operative assessment and at 3 month post-operative assessment]
• Grip Strength [Срок оценки: At pre-operative assessment and at 3 month post-operative assessment]
• Intensity of Movement using ActiGraph Accelerometry [Срок оценки: At pre-operative assessment and at 3 month post-operative assessment]
• Frequency of Movement using ActiGraph Accelerometry [Срок оценки: At pre-operative assessment and at 3 month post-operative assessment]
• Duration of Movement using ActiGraph Accelerometry [Срок оценки: At pre-operative assessment and at 3 month post-operative assessment]
• CHAMPS Questionnaire Score [Срок оценки: At pre-operative assessment and at 3 month post-operative assessment]
• Pasieka Parathyroidectomy Assessment of Symptoms (PAS) [Срок оценки: At pre-operative assessment and at 3 month post-operative assessment]
• Concentration of Plasma Cytokine Biomarkers [Срок оценки: 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]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Clinical and Translational Research Building — Gainesville

Идентификаторы

NCT: NCT07103876 · IRB202500602 · P30AG028740

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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