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Study on Zoledronic Acid and Placebo Before Parathyroid Surgery in Patients with Primary Hyperparathyroidism

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for Primary Hyperparathyroidism, a condition where the parathyroid glands in the neck produce too much parathyroid hormone, leading to high levels of calcium in the blood. The study will compare the effects of a medication called Zoledronic Acid, which is a type of drug known as a bisphosphonate, with a placebo. Zoledronic Acid is given as a solution through an intravenous infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of the study is to investigate how the treatment affects the bones, kidneys, and cardiovascular system of patients with primary hyperparathyroidism one year after they have undergone surgery to remove the overactive parathyroid glands, a procedure known as parathyroidectomy. Participants in the study will receive either Zoledronic Acid or a placebo before their surgery. The study will monitor changes in bone density, which is a measure of bone strength, as well as other health indicators related to the heart and kidneys over the course of a year following the surgery.

Throughout the study, participants will undergo various assessments to evaluate the effects of the treatment. These assessments will include measurements of bone density at different parts of the body, such as the spine and hip, using techniques like high-resolution peripheral computed tomography (HRpQCT), which is a type of imaging that provides detailed pictures of the bone structure. The study will also look at biochemical markers that indicate bone turnover, which is the process of bone renewal, and will assess the presence of any kidney calcifications or changes in urinary substances. The trial aims to provide valuable insights into the potential benefits of using Zoledronic Acid in managing primary hyperparathyroidism.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Randomization
Upon joining the study, participants are randomly assigned to one of two groups: one receiving bisphosphonate treatment and the other receiving a placebo. This process is conducted in a manner that ensures neither the participants nor the researchers know which group each participant is in, maintaining the study's blinded nature.
Step 2
Medication administration
Participants in the treatment group receive an infusion of zoledronic acid, a type of bisphosphonate, at a dosage of 4 mg/100 ml. This is administered as an intravenous infusion.
Participants in the placebo group receive an infusion of sodium chloride solution, also administered as an intravenous infusion.
Step 3
Parathyroidectomy
All participants undergo a surgical procedure called parathyroidectomy (PTX), which involves the removal of one or more parathyroid glands. This is a standard treatment for primary hyperparathyroidism.
Step 4
Post-surgery monitoring
Following the surgery, participants are monitored for changes in bone density and other health markers. This includes assessments of bone mineral density (BMD) at various sites such as the lumbar spine, distal forearm, femoral neck, and total hip.
Additional evaluations include high-resolution peripheral computed tomography (HRpQCT) to assess bone microarchitecture, and measurements of biochemical bone turnover markers (BTM).
Step 5
Long-term follow-up
Participants are followed for one year after the surgery to evaluate the long-term effects of the treatment. This includes further assessments of bone density, cardiovascular health, and kidney function.
Specific evaluations include measurements of volumetric bone mineral density (vBMD) at the hip and lumbar spine, coronary artery calcium score (CACS), pulse wave velocity (PWV), and assessments of renal calcifications and urinary analytes.

Who can join the trial?

5 criteria

Must be a postmenopausal female or a male over 50 years old.
Must have a diagnosis of hyperparathyroid hypercalcemia due to a condition called sporadic primary hyperparathyroidism (PHPT) and be referred for a surgery called parathyroidectomy (PTX).
Must have a bone mineral density (BMD) T-score of -1 or lower at the total hip, femoral neck, or lumbar spine. The T-score is a measure used to assess bone strength.
Must have a level of 25-hydroxyvitamin D that is 50 nmol/l or higher before being randomly assigned to a treatment group. This is a measure of vitamin D in the blood.
Must be willing to undergo the surgery called parathyroidectomy (PTX).

Who cannot join the trial?

4 criteria

Patients who do not have primary hyperparathyroidism cannot participate. This is a condition where the parathyroid glands in the neck produce too much parathyroid hormone, which can affect bones, kidneys, and the heart.
Patients who are not within the specified age range cannot participate. The study includes adults, typically those aged 18 and older.
Both men and women can participate, so gender is not a reason for exclusion.
Patients who are part of a vulnerable population, such as those unable to give informed consent, are not included in this study.

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Verified sites

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Aarhus University Hospital
Aarhus, Denmark

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Investigated drugs

Bisphosphonate is a type of medication used to help strengthen bones. In this clinical trial, it is being tested to see how it affects the bones, kidneys, and cardiovascular system in patients with primary hyperparathyroidism who are undergoing parathyroid surgery. The goal is to understand its benefits one year after the surgery.

What is already known about the treatment

Bisphosphonate – Bisphosphonates are typically administered orally or through intravenous infusion. They are currently well-established in medical literature for their role in treating bone-related conditions. The main therapeutic indication for bisphosphonates in this trial is primary hyperparathyroidism, particularly in the context of preparing for parathyroidectomy. At the molecular level, bisphosphonates work by inhibiting osteoclast-mediated bone resorption, which helps to maintain bone density. They are classified pharmacologically as bone density conservation agents.

Investigated diseases

Primary Hyperparathyroidism – This condition occurs when one or more of the parathyroid glands become overactive, leading to an excess production of parathyroid hormone. This hormone imbalance results in elevated calcium levels in the blood, which can cause a variety of symptoms. Common effects include weakened bones, kidney stones, and issues with the cardiovascular system. Over time, the high calcium levels can lead to bone pain, fatigue, and depression. The disease often progresses slowly, and symptoms may be mild or absent initially. If left unchecked, it can lead to more significant health problems related to the bones and kidneys.