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

Primary Purpose

Hypoparathyroidism Postprocedural, Quality of Life

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Empiric use of Calcium Carbonate and Calcitriol
PTH based Calcium Carbonate and Calcitriol repletion
Sponsored by
CHU de Quebec-Universite Laval
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoparathyroidism Postprocedural

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • CHU de QuebecRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Empiric calcium and calcitriol repletion group

PTH based repletion group

Arm Description

All patients in this group will receive post-operative calcium carbonate and calcitriol.

Patients in this group will be prescribed calcium carbonate and calcitriol based on their post-operative PTH.

Outcomes

Primary Outcome Measures

Change from baseline quality of life at 1 and 4 weeks
Short Form 36 (SF-36) questionnaire

Secondary Outcome Measures

Occurence and change in pharmacologic adverse effects of calcium carbonate and calcitriol
A questionnaire about the adverse effects of calcium carbonate and calcitriol will be completed at post-op week 1 and 4
Occurence and change in symptoms of hypocalcemia
A questionnaire about symptoms of hypocalcemia will be completed at post-op week 1 and 4.

Full Information

First Posted
August 9, 2017
Last Updated
February 15, 2023
Sponsor
CHU de Quebec-Universite Laval
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1. Study Identification

Unique Protocol Identification Number
NCT03249012
Brief Title
Quality of Life Related to Different Treatment Protocols for Post-thyroidectomy Hypoparathyroidism
Official Title
Comparing the Quality of Life Associated With Empiric Calcium Repletion and Parathormone (PTH) Based Calcium Repletion for Post Thyroidectomy Hypoparathyroidism
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CHU de Quebec-Universite Laval

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoparathyroidism Postprocedural, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Empiric calcium and calcitriol repletion group
Arm Type
Experimental
Arm Description
All patients in this group will receive post-operative calcium carbonate and calcitriol.
Arm Title
PTH based repletion group
Arm Type
Experimental
Arm Description
Patients in this group will be prescribed calcium carbonate and calcitriol based on their post-operative PTH.
Intervention Type
Other
Intervention Name(s)
Empiric use of Calcium Carbonate and Calcitriol
Intervention Description
Empiric calcium carbonate and calcitriol repletion
Intervention Type
Other
Intervention Name(s)
PTH based Calcium Carbonate and Calcitriol repletion
Intervention Description
PTH based treatment
Primary Outcome Measure Information:
Title
Change from baseline quality of life at 1 and 4 weeks
Description
Short Form 36 (SF-36) questionnaire
Time Frame
Pre-op, 1 week post-op and 4 weeks post-op
Secondary Outcome Measure Information:
Title
Occurence and change in pharmacologic adverse effects of calcium carbonate and calcitriol
Description
A questionnaire about the adverse effects of calcium carbonate and calcitriol will be completed at post-op week 1 and 4
Time Frame
1 week post-op, 4 weeks post-op
Title
Occurence and change in symptoms of hypocalcemia
Description
A questionnaire about symptoms of hypocalcemia will be completed at post-op week 1 and 4.
Time Frame
1 week post-op, 4 weeks post-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Philippe Vezina, MD, FRCSC
Phone
418-649-0252
Email
jean-philippe.vezina@fmed.ulaval.ca
Facility Information:
Facility Name
CHU de Quebec
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1J1Z4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Philippe Vezina, MD
Phone
418-649-0252
Email
jean-philippe.vezina@fmed.ulaval.ca

12. IPD Sharing Statement

Learn more about this trial

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

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