Quality of Life Related to Different Treatment Protocols for Post-thyroidectomy Hypoparathyroidism

February 15, 2023 updated by: Jean-Philippe Vézina, CHU de Quebec-Universite Laval

Comparing the Quality of Life Associated With Empiric Calcium Repletion and Parathormone (PTH) Based Calcium Repletion for Post Thyroidectomy Hypoparathyroidism

This study aims to compare two different protocols commonly used in the management of post thyroidectomy hypoparathyroidism : PTH based calcium repletion and empiric repletion. The investigators aim to compare the quality of life associated with these two protocols in a randomized trial.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Enrolled patients will be randomized in two treatment groups. In group 1, all patients will receive calcium carbonate and calcitriol in the post-operative period, with standardized weaning. In group 2, patients will be prescribed calcium carbonate and calcitriol only if their post-operative PTH dosage is 25% or less of the pre-operative dosage, or if post-operative PTH is inferior to 15.

The Short-Form 36 (SF-36) questionnaire (French canadian version) will be used to assess quality of life pre-operatively and at post-op week 1 and 4. Symptoms of hypocalcemia and adverse effects of calcium carbonate and calcitriol will be monitored at week 1 and 4.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Québec, Quebec, Canada, G1J1Z4
        • Recruiting
        • CHU de Québec

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Total thyroidectomy or completion hemithyroidectomy

Exclusion Criteria:

  • Need for neck dissection
  • Unable to fill in questionnaires (intellectual deficit, severe psychiatric disorder, illiterate, does not speak French or English)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Empiric calcium and calcitriol repletion group
All patients in this group will receive post-operative calcium carbonate and calcitriol.
Other: Empiric use of Calcium Carbonate and Calcitriol
Empiric calcium carbonate and calcitriol repletion
Experimental: PTH based repletion group
Patients in this group will be prescribed calcium carbonate and calcitriol based on their post-operative PTH.
Other: PTH based Calcium Carbonate and Calcitriol repletion
PTH based treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline quality of life at 1 and 4 weeks
Time Frame: Pre-op, 1 week post-op and 4 weeks post-op
Short Form 36 (SF-36) questionnaire
Pre-op, 1 week post-op and 4 weeks post-op

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurence and change in pharmacologic adverse effects of calcium carbonate and calcitriol
Time Frame: 1 week post-op, 4 weeks post-op
A questionnaire about the adverse effects of calcium carbonate and calcitriol will be completed at post-op week 1 and 4
1 week post-op, 4 weeks post-op
Occurence and change in symptoms of hypocalcemia
Time Frame: 1 week post-op, 4 weeks post-op
A questionnaire about symptoms of hypocalcemia will be completed at post-op week 1 and 4.
1 week post-op, 4 weeks post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Quebec-Universite Laval

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Anticipated)

September 1, 2025

Study Completion (Anticipated)

September 1, 2025

Study Registration Dates

First Submitted

August 9, 2017

First Submitted That Met QC Criteria

August 10, 2017

First Posted (Actual)

August 15, 2017

Study Record Updates

Last Update Posted (Actual)

February 17, 2023

Last Update Submitted That Met QC Criteria

February 15, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-3422

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Quality of Life

Clinical Trials on Empiric use of Calcium Carbonate and Calcitriol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe