Clinical trial NCT04798092: Impact of Parathyroidectomy on Renal Function
Official title: Impact of Parathyroidectomy on Renal Function in Patients With Primary Hyperparathyroidism
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Primary Hyperparathyroidism
Keywords: Primary Hyperparathyroidism
Renal function
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-03-15
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing parathyroidectomy for primary hyperparathyroidism with surgical cure defined as postoperative normocalciemia

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.

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"

Eligibility criteria: 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

Primary outcomes:
measure: Change in renal function
timeFrame: preoperative, postoperative at 3, 6, and 12 months
Secondary outcomes:
measure: Change in calcium
timeFrame: preoperative, postoperative at 3, 6, and 12 months
measure: Change in parathormone
timeFrame: preoperative, postoperative at 3, 6, and 12 months
measure: Change in vitamin D
timeFrame: preoperative, postoperative at 3, 6, and 12 months
measure: Change in urinary calcium
timeFrame: preoperative, postoperative at 3, 6, and 12 months
measure: Change in insulin
timeFrame: preoperative, postoperative at 3, 6, and 12 months
measure: Change in glycemia
timeFrame: preoperative, postoperative at 3, 6, and 12 months
measure: Change in osteocalcin
timeFrame: preoperative, postoperative at 3, 6, and 12 months
measure: Change in bone alkaline phosphatases
timeFrame: preoperative, postoperative at 3, 6, and 12 months
measure: Change in aldosterone
timeFrame: preoperative, postoperative at 3, 6, and 12 months
measure: Change in renin
timeFrame: preoperative, postoperative at 3, 6, and 12 months
measure: Change in total cholesterol
timeFrame: preoperative, postoperative at 3, 6, and 12 months
measure: Change in HDL cholesterol
timeFrame: preoperative, postoperative at 3, 6, and 12 months
measure: Change in LDL cholesterol
timeFrame: preoperative, postoperative at 3, 6, and 12 months
measure: Change in triglycerides
timeFrame: preoperative, postoperative at 3, 6, and 12 months
measure: CAC scoring on CT scan
timeFrame: preoperative
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU Nancy
state: Lorraine
Study officials:
affiliation: CHU NANCY
name: Brunaud
role: PRINCIPAL_INVESTIGATOR
References: