Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-29 @ 6:53 AM
Study NCT ID:
NCT03249012
Status:
RECRUITING
Last Update Posted:
2024-08-28
First Post:
2017-08-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life Related to Different Treatment Protocols for Post-thyroidectomy Hypoparathyroidism
Sponsor:
CHU de Quebec-Universite Laval
Organization:
Study Overview
Official Title:
Comparing the Quality of Life Associated With Empiric Calcium Repletion and Parathormone (PTH) Based Calcium Repletion for Post Thyroidectomy Hypoparathyroidism
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: