In short
Currently, there is 1 ongoing clinical trial investigating treatment approaches for Primary Hyperparathyroidism, a condition where the parathyroid glands produce too much parathyroid hormone, leading to high calcium levels in the blood. This trial is examining how medication given before parathyroid surgery may help protect bone health and improve outcomes for patients.
Clinical trial locations
Study on Zoledronic Acid and Placebo Before Parathyroid Surgery in Patients with Primary Hyperparathyroidism
This clinical trial, taking place in Denmark, is investigating whether giving patients a medication called Zoledronic Acid before parathyroid surgery can improve their bone health, kidney function, and heart health one year after the operation.
Main inclusion criteria:
- Postmenopausal women or men over 50 years old
- Diagnosed with sporadic primary hyperparathyroidism and scheduled for parathyroid surgery (parathyroidectomy)
- Bone mineral density T-score of -1 or lower at the total hip, femoral neck, or lumbar spine, indicating reduced bone strength
- Vitamin D level (25-hydroxyvitamin D) of 50 nmol/l or higher
- Willing to undergo parathyroid surgery
Main exclusion criteria:
- Patients without primary hyperparathyroidism
- Patients outside the specified age range
- Vulnerable populations unable to provide informed consent
Focus and goals:
The study aims to understand how Zoledronic Acid, a type of bisphosphonate medication, affects patients' bones, kidneys, and cardiovascular system after parathyroid surgery. Participants are randomly assigned to receive either Zoledronic Acid or a placebo through an intravenous infusion before their surgery. Neither the participants nor the researchers know which treatment each person receives, ensuring unbiased results.
After the infusion, all participants undergo parathyroidectomy, a surgical procedure to remove overactive parathyroid glands. Following surgery, researchers carefully monitor changes in bone density at various body sites including the spine, hip, and forearm using specialized imaging techniques. The study also tracks biochemical markers that show how bones are renewing themselves, evaluates heart health through measurements like coronary artery calcium scores and pulse wave velocity, and assesses kidney function and the presence of kidney calcifications.
Participants are followed for one year after surgery, allowing researchers to understand the long-term effects of the treatment on bone strength, cardiovascular health, and kidney function.
Investigational drug:
The trial is testing Zoledronic Acid, a bisphosphonate medication administered at a dose of 4 mg/100 ml through intravenous infusion. Bisphosphonates work at the molecular level by preventing bone breakdown, helping to maintain bone density. They are well-established medications for bone-related conditions and are classified as bone density conservation agents. In this trial, the medication is being studied specifically for its potential to improve outcomes in patients preparing for parathyroid surgery.
Summary
This single ongoing trial represents an important investigation into improving treatment outcomes for primary hyperparathyroidism. Located in Denmark, the study focuses on whether administering Zoledronic Acid before surgery can provide additional benefits to patients beyond the standard surgical treatment. The trial's comprehensive approach examines not only bone health but also cardiovascular and kidney function, recognizing that primary hyperparathyroidism affects multiple body systems. By following patients for one year after surgery, researchers hope to gain valuable insights into the potential long-term benefits of this treatment approach for managing the condition.
