Quality of Life Related to Different Treatment Protocols for Post-thyroidectomy Hypoparathyroidism
Comparing the Quality of Life Associated With Empiric Calcium Repletion and Parathormone (PTH) Based Calcium Repletion for Post Thyroidectomy Hypoparathyroidism
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2017
CompletedFirst Posted
Study publicly available on registry
August 15, 2017
CompletedStudy Start
First participant enrolled
September 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedAugust 28, 2024
August 1, 2024
8 years
August 9, 2017
August 26, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline quality of life at 1 and 4 weeks
Short Form 36 (SF-36) questionnaire
Pre-op, 1 week post-op and 4 weeks post-op
Secondary Outcomes (2)
Occurence and change in pharmacologic adverse effects of calcium carbonate and calcitriol
1 week post-op, 4 weeks post-op
Occurence and change in symptoms of hypocalcemia
1 week post-op, 4 weeks post-op
Study Arms (2)
Empiric calcium and calcitriol repletion group
EXPERIMENTALAll patients in this group will receive post-operative calcium carbonate and calcitriol.
PTH based repletion group
EXPERIMENTALPatients in this group will be prescribed calcium carbonate and calcitriol based on their post-operative PTH.
Interventions
Empiric calcium carbonate and calcitriol repletion
PTH based treatment
Eligibility Criteria
You may qualify if:
- Total thyroidectomy or completion hemithyroidectomy
You may not qualify if:
- Need for neck dissection
- Unable to fill in questionnaires (intellectual deficit, severe psychiatric disorder, illiterate, does not speak French or English)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Quebec
Québec, Quebec, G1J1Z4, Canada
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Otolaryngologist and Head & Neck Surgeon
Study Record Dates
First Submitted
August 9, 2017
First Posted
August 15, 2017
Study Start
September 1, 2017
Primary Completion
September 1, 2025
Study Completion
September 1, 2025
Last Updated
August 28, 2024
Record last verified: 2024-08