What side effects are associated with this type of intervention?

The most common treatments for hypoparathyroidism include PTH-based calcium repletion and standard calcium supplementation. PTH-based calcium repletion, which involves adjusting calcium intake based on parathyroid hormone levels, can lead to side effects such as hypercalcemia, hypocalcemia, and potential bone resorption issues. Standard calcium supplementation, often combined with vitamin D, can cause gastrointestinal symptoms like constipation, nausea, and in some cases, hypercalcemia if not properly monitored. Both treatments require careful monitoring to avoid complications related to calcium imbalance.

What prior FDA approvals exist?

The FDA has approved treatments for hypoparathyroidism that include calcium and vitamin D supplementation to manage calcium levels. Additionally, recombinant parathyroid hormone (PTH) therapies, such as Natpara (parathyroid hormone), have been approved to help regulate calcium and phosphate metabolism in patients with hypoparathyroidism. These treatments align with the approaches being studied in the trial comparing PTH-based calcium repletion (guided by PTH levels) versus empiric repletion (standard calcium supplementation).

What other types of research exist?

Promising novel alternatives for hypoparathyroidism treatment in 2024 may include the use of anabolic agents like abaloparatide and romosozumab, which have shown efficacy in bone density improvement. Additionally, denosumab, a RANKL inhibitor, could be considered for its role in bone remodeling and calcium metabolism. These agents, while primarily used for osteoporosis, may offer new avenues for managing hypoparathyroidism by enhancing bone health and calcium homeostasis.

← Back to Search

Calcium and Calcitriol Protocols for Hypoparathyroidism

N/A

Recruiting

Research Sponsored by CHU de Quebec-Universite Laval

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Total thyroidectomy or completion hemithyroidectomy

Be older than 18 years old

Must not have

Need for neck dissection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 week post-op, 4 weeks post-op

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two ways to give calcium and vitamin D to patients with low hormone levels after thyroid surgery. One method gives supplements to everyone right away, while the other gives them only if hormone levels drop significantly. The goal is to see which method improves quality of life more.

Who is the study for?

This trial is for individuals who have undergone a total thyroidectomy or completion hemithyroidectomy and are dealing with hypoparathyroidism. Participants must be able to complete questionnaires in English or French, without severe psychiatric disorders, intellectual deficits, illiteracy, or the need for neck dissection.

What is being tested?

The study compares two treatment protocols for managing low parathyroid hormone levels after thyroid surgery: one uses PTH levels to determine calcium and vitamin D dosing (Calcitriol), while the other uses a fixed dose regardless of PTH levels.

What are the potential side effects?

Potential side effects may include variations in calcium levels leading to symptoms like tingling sensations, muscle cramps or spasms. Overdosing could cause high calcium symptoms such as stomach pain, constipation, confusion, or kidney stones.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had my entire thyroid or half of it surgically removed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I need surgery to remove lymph nodes in my neck.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 week post-op, 4 weeks post-op

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 week post-op, 4 weeks post-op

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week post-op, 4 weeks post-op for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline quality of life at 1 and 4 weeks

Secondary study objectives

Occurence and change in pharmacologic adverse effects of calcium carbonate and calcitriol

Occurence and change in symptoms of hypocalcemia

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: PTH based repletion groupExperimental Treatment1 Intervention

Patients in this group will be prescribed calcium carbonate and calcitriol based on their post-operative PTH.

Group II: Empiric calcium and calcitriol repletion groupExperimental Treatment1 Intervention

All patients in this group will receive post-operative calcium carbonate and calcitriol.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for hypoparathyroidism include calcium and vitamin D supplementation, as well as parathyroid hormone (PTH) therapy. Calcium supplements help to directly increase serum calcium levels, which are typically low in hypoparathyroidism due to insufficient PTH. Vitamin D enhances calcium absorption from the gut, further aiding in maintaining adequate calcium levels. PTH therapy, on the other hand, directly replaces the deficient hormone, helping to regulate calcium and phosphate metabolism more naturally. This is crucial for hypoparathyroidism patients as it can more effectively mimic the body's natural calcium regulation, potentially reducing the risk of complications such as hypocalcemia and improving overall quality of life.