AzTrials
AzTrials

Primary HyperparathyroidismPARA-REINNCT04798092

Impact of Parathyroidectomy on Renal Function

An observational study of Primary Hyperparathyroidism, run by Central Hospital, Nancy, France at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Primary Hyperparathyroidism
What is being tested?
parathyroidectomy
Type of treatment
Surgery or procedure
How many people
500 participants
Where
1 siteFrance
Study dates
1 Jan 2010to Jan 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

laurent Brunaud contact

l.brunaud@chru-nancy.fr

France1 site, 1 recruiting

  • CHRU Nancy

    Vandœuvre-lès-Nancy, Lorraine, 54511

    Brunaud, l.brunaud@chru-nancy.fr

    Recruiting

Other trials in France

About this study

Official title: 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.

Read the 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"

Being tested
parathyroidectomy
Keywords
Primary Hyperparathyroidism, Renal function
Medical subject headings
Hyperparathyroidism, Primary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • parathyroidectomyProcedure or surgery

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in renal function

    glomerular filtration rate (CKD in mL/min)

    Measured: preoperative, postoperative at 3, 6, and 12 months

Secondary outcomes (15)

  1. Change in calcium

    Blood calcium level (in mg/L)

    Measured: preoperative, postoperative at 3, 6, and 12 months

  2. Change in parathormone

    Blood parathormone level (in ng/dL)

    Measured: preoperative, postoperative at 3, 6, and 12 months

  3. Change in vitamin D

    Blood vitamine D level (in ng/mL)

    Measured: preoperative, postoperative at 3, 6, and 12 months

  4. Change in urinary calcium

    Urine calcium level (in mg/24h)

    Measured: preoperative, postoperative at 3, 6, and 12 months

  5. Change in insulin

    Fasting blood insuline level (in mUI/L)

    Measured: preoperative, postoperative at 3, 6, and 12 months

  6. Change in glycemia

    Fasting blood glucose level (in g/L)

    Measured: preoperative, postoperative at 3, 6, and 12 months

  7. Change in osteocalcin

    Blood osteocalcin level (in ng/mL)

    Measured: preoperative, postoperative at 3, 6, and 12 months

  8. Change in bone alkaline phosphatases

    Blood bone alkaline phosphatases level (in microgr/L)

    Measured: preoperative, postoperative at 3, 6, and 12 months

  9. Change in aldosterone

    Blood aldosterone level (in pg/mL)

    Measured: preoperative, postoperative at 3, 6, and 12 months

  10. Change in renin

    Blood active renin (in pg/mL)

    Measured: preoperative, postoperative at 3, 6, and 12 months

  11. Change in total cholesterol

    Blood total cholesterol (in gr/L)

    Measured: preoperative, postoperative at 3, 6, and 12 months

  12. Change in HDL cholesterol

    Blood HDL Cholesterol (in gr/L)

    Measured: preoperative, postoperative at 3, 6, and 12 months

  13. Change in LDL cholesterol

    Blood LDL Cholesterol (in gr/L)

    Measured: preoperative, postoperative at 3, 6, and 12 months

  14. Change in triglycerides

    Blood triglycerides (in gr/L)

    Measured: preoperative, postoperative at 3, 6, and 12 months

  15. CAC scoring on CT scan

    CAC score (actual value)

    Measured: preoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2021
  2. Study start1 Jan 2010
  3. Primary completionJan 2023 (estimated)
  4. Study completionJan 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04798092
Sponsor's protocol ID
2020PI099
Acronym
PARA-REIN
Status last verified
Jan 2022
First submitted
29 Jan 2021
Last updated
5 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Primary Hyperparathyroidism, run by Central Hospital, Nancy, France at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact laurent Brunaud (l.brunaud@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in renal function (time frame: preoperative, postoperative at 3, 6, and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04798092.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2022; AzTrials last refreshed its copy on 31 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in