PARA-REIN: Impact of Parathyroidectomy on Renal Function

• Sponsor: Central Hospital, Nancy, France (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04798092
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Anticipated Duration (Months): 144
• Patients Per Site Per Month: 3.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Hyperparathyroidism	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 Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Impact of Parathyroidectomy on Renal Function in Patients With Primary Hyperparathyroidism
• Actual Study Start Date: Jan 1, 2010
• Anticipated Primary Completion Date: Jan 1, 2022
• Anticipated Study Completion Date: Jan 1, 2022

Outcome Measures

Primary Outcome Measures

1. Change in renal function [preoperative, postoperative at 3, 6, and 12 months]

   glomerular filtration rate (CKD in mL/min)

Secondary Outcome Measures

1. Change in calcium [preoperative, postoperative at 3, 6, and 12 months]

   Blood calcium level (in mg/L)

2. Change in parathormone [preoperative, postoperative at 3, 6, and 12 months]

   Blood parathormone level (in ng/dL)

3. Change in vitamin D [preoperative, postoperative at 3, 6, and 12 months]

   Blood vitamine D level (in ng/mL)

4. Change in urinary calcium [preoperative, postoperative at 3, 6, and 12 months]

   Urine calcium level (in mg/24h)

5. Change in insulin [preoperative, postoperative at 3, 6, and 12 months]

   Fasting blood insuline level (in mUI/L)

6. Change in glycemia [preoperative, postoperative at 3, 6, and 12 months]

   Fasting blood glucose level (in g/L)

7. Change in osteocalcin [preoperative, postoperative at 3, 6, and 12 months]

   Blood osteocalcin level (in ng/mL)

8. Change in bone alkaline phosphatases [preoperative, postoperative at 3, 6, and 12 months]

   Blood bone alkaline phosphatases level (in microgr/L)

9. Change in aldosterone [preoperative, postoperative at 3, 6, and 12 months]

   Blood aldosterone level (in pg/mL)

10. Change in renin [preoperative, postoperative at 3, 6, and 12 months]

    Blood active renin (in pg/mL)

11. Change in total cholesterol [preoperative, postoperative at 3, 6, and 12 months]

    Blood total cholesterol (in gr/L)

12. Change in HDL cholesterol [preoperative, postoperative at 3, 6, and 12 months]

    Blood HDL Cholesterol (in gr/L)

13. Change in LDL cholesterol [preoperative, postoperative at 3, 6, and 12 months]

    Blood LDL Cholesterol (in gr/L)

14. Change in triglycerides [preoperative, postoperative at 3, 6, and 12 months]

    Blood triglycerides (in gr/L)

15. CAC scoring on CT scan [preoperative]

    CAC score (actual value)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHRU Nancy	Vandœuvre-lès-Nancy	Lorraine	France	54511

Sponsors and Collaborators

• Central Hospital, Nancy, France

Investigators

• Principal Investigator: Brunaud, CHU Nancy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Central Hospital, Nancy, France
• ClinicalTrials.gov Identifier: NCT04798092
• Other Study ID Numbers: 2020PI099
• First Posted: Mar 15, 2021
• Last Update Posted: Mar 15, 2021
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Central Hospital, Nancy, France: Primary Hyperparathyroidism; Renal function
• Additional relevant MeSH terms: Hyperparathyroidism; Hyperparathyroidism, Primary

Study Results

No Results Posted as of Mar 15, 2021