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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empiric calcium and calcitriol repletion group | Experimental | All patients in this group will receive post-operative calcium carbonate and calcitriol. |
|
| PTH based repletion group | Experimental | Patients in this group will be prescribed calcium carbonate and calcitriol based on their post-operative PTH. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empiric use of Calcium Carbonate and Calcitriol | Other | Empiric calcium carbonate and calcitriol repletion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 week post-op, 4 weeks post-op |
| Occurence and change in symptoms of hypocalcemia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean-Philippe Vezina, MD, FRCSC | Contact | 418-649-0252 | jean-philippe.vezina@fmed.ulaval.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Quebec | Recruiting | Québec | Quebec | G1J1Z4 | Canada |
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| PTH based Calcium Carbonate and Calcitriol repletion | Other | PTH based treatment |
|
A questionnaire about symptoms of hypocalcemia will be completed at post-op week 1 and 4. |
| 1 week post-op, 4 weeks post-op |
| ID | Term |
|---|---|
| D002117 | Calcitriol |
| ID | Term |
|---|---|
| D004100 | Dihydroxycholecalciferols |
| D006887 | Hydroxycholecalciferols |
| D002762 | Cholecalciferol |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
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