An interventional study of Empiric use of Calcium Carbonate and Calcitriol and PTH based Calcium Carbonate and Calcitriol repletion in Hypoparathyroidism Postprocedural and Quality of Life, sponsored by CHU de Quebec-Universite Laval. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-28.
Sponsored by CHU de Quebec-Universite Laval · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
All patients in this group will receive post-operative calcium carbonate and calcitriol.
Other: Empiric use of Calcium Carbonate and Calcitriol
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
Empiric calcium carbonate and calcitriol repletion
PTH based treatment
Change from baseline quality of life at 1 and 4 weeks
Short Form 36 (SF-36) questionnaire
Time frame: Pre-op, 1 week post-op and 4 weeks post-op
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
Time frame: 1 week post-op, 4 weeks post-op
Occurence and change in symptoms of hypocalcemia
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
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CHU de Quebec-Universite Laval