Impact of Parathyroidectomy on Renal Function (PARA-REIN)

Impact of Parathyroidectomy on Renal Function in Patients With Primary Hyperparathyroidism

Primary hyperparathyroidism (PHPT) is a disorder of one or more of the parathyroid glands. The parathyroid gland(s) becomes overactive and secretes excess amounts of parathyroid hormone (PTH). As a result, the blood calcium rises to a level that is higher than normal. PHPT is associated with several other metabolic complications as osteoporosis, kidney stones, hypertension, insulin resistance, cardiac calcifications, cardiac arrhythmias, and kidney failure. Renal function deterioration over time has also been reported. However, the role of parathyroidectomy on renal function remains controversial in patients with PHPT. In some studies, surgical cure of PHPT has been shown to halt renal function deterioration in patients with coexisting renal disease. On the other hand, other studies showed no significant impact of parathyroidectomy on renal function. Consequently, the goal of this study was to evaluate renal function before and after parathyroidectomy in a large cohort of patients with pHPT.

Study Overview

• Status: Recruiting
• Conditions: Primary Hyperparathyroidism
• Intervention / Treatment: Procedure: parathyroidectomy

Detailed Description

Primary hyperparathyroidism (PHPT) is a disorder of one or more of the parathyroid glands. The parathyroid gland(s) becomes overactive and secretes excess amounts of parathyroid hormone (PTH). As a result, the blood calcium rises to a level that is higher than normal. PHPT is associated with several other metabolic complications as osteoporosis, kidney stones, hypertension, insulin resistance, cardiac calcifications, cardiac arrhythmias, and kidney failure. Renal function deterioration over time has also been reported. However, the role of parathyroidectomy on renal function remains controversial in patients with PHPT. In some studies, surgical cure of PHPT has been shown to halt renal function deterioration in patients with coexisting renal disease. On the other hand, other studies showed no significant impact of parathyroidectomy on renal function. Consequently, the goal of this study was to evaluate renal function before and after parathyroidectomy in a large cohort of patients with pHPT.

Criteria are detailled in "Outcomes measures"

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• France
  • Lorraine
    • Vandœuvre-lès-Nancy, Lorraine, France, 54511
      • Recruiting
      • CHRU Nancy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients undergoing parathyroidectomy for primary hyperparathyroidism with surgical cure defined as postoperative normocalciemia

Description

Inclusion Criteria:

- patients undergoing parathyroidectomy for primary hyperparathyroidism with surgical cure defined as postoperative normocalciemia

Exclusion Criteria:

• patients on dialysis
• GFR < 15 ml/min
• renal graft

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in renal function	glomerular filtration rate (CKD in mL/min)	preoperative, postoperative at 3, 6, and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in calcium	Blood calcium level (in mg/L)	preoperative, postoperative at 3, 6, and 12 months
Change in parathormone	Blood parathormone level (in ng/dL)	preoperative, postoperative at 3, 6, and 12 months
Change in vitamin D	Blood vitamine D level (in ng/mL)	preoperative, postoperative at 3, 6, and 12 months
Change in urinary calcium	Urine calcium level (in mg/24h)	preoperative, postoperative at 3, 6, and 12 months
Change in insulin	Fasting blood insuline level (in mUI/L)	preoperative, postoperative at 3, 6, and 12 months
Change in glycemia	Fasting blood glucose level (in g/L)	preoperative, postoperative at 3, 6, and 12 months
Change in osteocalcin	Blood osteocalcin level (in ng/mL)	preoperative, postoperative at 3, 6, and 12 months
Change in bone alkaline phosphatases	Blood bone alkaline phosphatases level (in microgr/L)	preoperative, postoperative at 3, 6, and 12 months
Change in aldosterone	Blood aldosterone level (in pg/mL)	preoperative, postoperative at 3, 6, and 12 months
Change in renin	Blood active renin (in pg/mL)	preoperative, postoperative at 3, 6, and 12 months
Change in total cholesterol	Blood total cholesterol (in gr/L)	preoperative, postoperative at 3, 6, and 12 months
Change in HDL cholesterol	Blood HDL Cholesterol (in gr/L)	preoperative, postoperative at 3, 6, and 12 months
Change in LDL cholesterol	Blood LDL Cholesterol (in gr/L)	preoperative, postoperative at 3, 6, and 12 months
Change in triglycerides	Blood triglycerides (in gr/L)	preoperative, postoperative at 3, 6, and 12 months
CAC scoring on CT scan	CAC score (actual value)	preoperative

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: January 29, 2021
• First Submitted That Met QC Criteria: March 11, 2021
• First Posted (Actual): March 15, 2021

Study Record Updates

• Last Update Posted (Actual): December 5, 2022
• Last Update Submitted That Met QC Criteria: December 2, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Primary Hyperparathyroidism; Renal function
• Additional Relevant MeSH Terms: Endocrine System Diseases; Parathyroid Diseases; Hyperparathyroidism; Hyperparathyroidism, Primary
• Other Study ID Numbers: 2020PI099

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No