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NCT Number: NCT03249012

Quality of Life Related to Different Treatment Protocols 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.

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Key information

Conditions

Hypoparathyroidism Postprocedural Quality of Life

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Quebec

Québec, Quebec, G1J1Z4, Canada

Location status: Recruiting

Location contact

Jean-Philippe Vezina, MD

CONTACT

[email protected]

418-649-0252

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Total thyroidectomy or completion hemithyroidectomy

Exclusion criteria

  • Need for neck dissection
  • Unable to fill in questionnaires (intellectual deficit, severe psychiatric disorder, illiterate, does not speak French or English)

Treatment and study plan

Empiric use of Calcium Carbonate and Calcitriol

Other

Empiric calcium carbonate and calcitriol repletion

PTH based Calcium Carbonate and Calcitriol repletion

Other

PTH based treatment

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-Philippe Vezina, MD, FRCSC

CONTACT

[email protected]

418-649-0252

Sponsors and collaborators

Lead sponsor

CHU de Quebec-Universite Laval

Other

Registry information

Official study title

Comparing the Quality of Life Associated With Empiric Calcium Repletion and Parathormone (PTH) Based Calcium Repletion for Post Thyroidectomy Hypoparathyroidism

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Aug 15, 2017
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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