Impact of Parathyroidectomy on Renal Function

NCT04798092 | Unknown

• 1 other identifier: 2020PI099
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Primary Hyperparathyroidism

Keywords

Primary Hyperparathyroidism; Renal function

Outcome Measures

Primary Outcomes (1)

• Change in renal function

  glomerular filtration rate (CKD in mL/min)

  preoperative, postoperative at 3, 6, and 12 months

Secondary Outcomes (15)

• Change in calcium

  preoperative, postoperative at 3, 6, and 12 months

• Change in parathormone

  preoperative, postoperative at 3, 6, and 12 months

• Change in vitamin D

  preoperative, postoperative at 3, 6, and 12 months

• Change in urinary calcium

  preoperative, postoperative at 3, 6, and 12 months

• Change in insulin

  preoperative, postoperative at 3, 6, and 12 months

Interventions

parathyroidectomy PROCEDURE

surgical removal of parathyroid adenoma(s) with postoperative biological cure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU Nancy

Vandœuvre-lès-Nancy, Lorraine, 54511, France

RECRUITING

MeSH Terms

Conditions

Hyperparathyroidism, Primary

Interventions

Parathyroidectomy

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Endocrine Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Brunaud

  CHU NANCY

  PRINCIPAL INVESTIGATOR

Central Study Contacts

laurent Brunaud

CONTACT

l.brunaud@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: March 15, 2021
• Study Start: January 1, 2010
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: December 5, 2022

Record last verified: 2022-01

Locations

FR (1)