Hypoparathyroidism PostproceduralNCT03249012
Quality of Life Related to Different Treatment Protocols for Post-thyroidectomy Hypoparathyroidism
A study testing Empiric use of Calcium Carbonate and Calcitriol and PTH based Calcium Carbonate and Calcitriol repletion in people with Hypoparathyroidism Postprocedural and Quality of Life, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoparathyroidism Postprocedural, Quality of Life
- What is being tested?
- Empiric use of Calcium Carbonate and Calcitriol and PTH based Calcium Carbonate and Calcitriol repletion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2017to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Total thyroidectomy or completion hemithyroidectomy
Who cannot join
- Need for neck dissection
- Unable to fill in questionnaires (intellectual deficit, severe psychiatric disorder, illiterate, does not speak French or English)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
CHU de Quebec
Québec, Quebec, G1J1Z4
Jean-Philippe Vezina, MD, 418-649-0252, jean-philippe.vezina@fmed.ulaval.ca
About this study
Official title: Comparing the Quality of Life Associated With Empiric Calcium Repletion and Parathormone (PTH) Based Calcium Repletion for Post Thyroidectomy Hypoparathyroidism
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.
Read the 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.
- Conditions
- Hypoparathyroidism Postprocedural, Quality of Life
- Being tested
- Empiric use of Calcium Carbonate and Calcitriol, PTH based Calcium Carbonate and Calcitriol repletion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empiric use of Calcium Carbonate and CalcitriolOther
Empiric calcium carbonate and calcitriol repletion
PTH based Calcium Carbonate and Calcitriol repletionOther
PTH based treatment
| Study group | Role | What they receive |
|---|---|---|
| Empiric calcium and calcitriol repletion group | Experimental | All patients in this group will receive post-operative calcium carbonate and calcitriol. Receives: Other: Empiric use of 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. Receives: Other: PTH based Calcium Carbonate and Calcitriol repletion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline quality of life at 1 and 4 weeks
Short Form 36 (SF-36) questionnaire
Measured: 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
A questionnaire about the adverse effects of calcium carbonate and calcitriol will be completed at post-op week 1 and 4
Measured: 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.
Measured: 1 week post-op, 4 weeks post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start1 Sep 2017
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoparathyroidism PostproceduralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Philippe Vézina, CHU de Quebec-Universite Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03249012
- Sponsor's protocol ID
- 2018-3422
- Status last verified
- Aug 2024
- First submitted
- 9 Aug 2017
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Quality of Life Associated With Empiric Calcium Repletion and Parathormone (PTH) Based Calcium Repletion for Post Thyroidectomy Hypoparathyroidism
- ClinicalTrials.gov ID
- NCT03249012
- Acronym / sponsor ID
- 2018-3422
- Conditions
- Hypoparathyroidism Postprocedural, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 15 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empiric calcium and calcitriol repletion group | Experimental | Other: Empiric use of Calcium Carbonate and CalcitriolAll patients in this group will receive post-operative calcium carbonate and calcitriol. |
| PTH based repletion group | Experimental | Other: PTH based Calcium Carbonate and Calcitriol repletionPatients in this group will be prescribed calcium carbonate and calcitriol based on their post-operative PTH. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Total thyroidectomy or completion hemithyroidectomy
Key exclusion criteria (2 listed)
- Need for neck dissection
- Unable to fill in questionnaires (intellectual deficit, severe psychiatric disorder, illiterate, does not speak French or English)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empiric use of Calcium Carbonate and CalcitriolEmpiric calcium carbonate and calcitriol repletion | Other | Empiric calcium and calcitriol repletion group |
| PTH based Calcium Carbonate and Calcitriol repletionPTH based treatment | Other | PTH based repletion group |
Primary outcome
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
2 secondary outcomes
Occurence and change in pharmacologic adverse effects of calcium carbonate and calcitriol
Time frame: 1 week post-op, 4 weeks post-op
Occurence and change in symptoms of hypocalcemia
Time frame: 1 week post-op, 4 weeks post-op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empiric use of Calcium Carbonate and Calcitriol and PTH based Calcium Carbonate and Calcitriol repletion in people with Hypoparathyroidism Postprocedural and Quality of Life, run by CHU de Quebec-Universite Laval at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Philippe Vezina, MD, FRCSC (418-649-0252, jean-philippe.vezina@fmed.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline quality of life at 1 and 4 weeks (time frame: Pre-op, 1 week post-op and 4 weeks post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.