Quality of Life Related to Different Treatment Protocols for Post-thyroidectomy Hypoparathyroidism
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03249012|
Recruitment Status : Recruiting
First Posted : August 15, 2017
Last Update Posted : January 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hypoparathyroidism Postprocedural Quality of Life||Other: Empiric use of Calcium Carbonate and Calcitriol Other: PTH based Calcium Carbonate and Calcitriol repletion||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparing the Quality of Life Associated With Empiric Calcium Repletion and Parathormone (PTH) Based Calcium Repletion for Post Thyroidectomy Hypoparathyroidism|
|Actual Study Start Date :||September 1, 2017|
|Estimated Primary Completion Date :||September 1, 2020|
|Estimated Study Completion Date :||September 1, 2020|
Experimental: Empiric calcium and calcitriol repletion group
All patients in this group will receive post-operative calcium carbonate and calcitriol.
Other: Empiric use of Calcium Carbonate and Calcitriol
Empiric calcium carbonate and calcitriol repletion
Experimental: PTH based repletion group
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
PTH based treatment
- Change from baseline quality of life at 1 and 4 weeks [ Time Frame: Pre-op, 1 week post-op and 4 weeks post-op ]Short Form 36 (SF-36) questionnaire
- Occurence and change in pharmacologic adverse effects of calcium carbonate and calcitriol [ Time Frame: 1 week post-op, 4 weeks post-op ]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 [ Time Frame: 1 week post-op, 4 weeks post-op ]A questionnaire about symptoms of hypocalcemia will be completed at post-op week 1 and 4.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03249012
|Contact: Jean-Philippe Vezina, MD, FRCSCemail@example.com|
|CHU de Quebec||Recruiting|
|Québec, Quebec, Canada, G1J1Z4|
|Contact: Jean-Philippe Vezina, MD 418-649-0252 firstname.lastname@example.org|