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You can access this
clinical trial
if you have
Primary Hyperparathyroidism, Parathyroid Adenoma or Parathyroid Hyperplasia
and you are
over 18
years old
3
This is a trial in the final phase before the treatment is released on the market.
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The purpose

The only known cure for primary hyperparathyroidism is surgical removal of one or more parathyroid glands. Some patients however, do not fulfill criteria for surgery or do not want to undergo a procedure due to fear of the associated risks. Therefore a medical alternative is warranted. This study aims to evaluate the effects of Denosumab alone, and in combination with Cinacalcet, as a medical treatment for patients suffering from primary hyperparathyroidism, with mild osteoporosis. To the best of our knowledge no previously reported randomized controlled trial has investigated the use of denosumab in primary hyperparathyroidism. 60 patients will be enrolled in three different treatment-groups: 20 receiving both Denosumab and Cinacalcet, 20 Denosumab and placebo and 20 placebo and placebo. Patients included do not meet the criteria for, or have no wish for a surgical procedure. By combining the two drugs, this study could possibly contribute to the discovery of a realistic medical alternative to surgery. It is expected that the therapy will be able to both control s-calcium and s-intact parathyroid hormone (iPTH), and simultaneously enhance bone-structure. The therapy thus has the potential of preventing fractures and possibly other long-term effects of primary hyperparathyroidism such as formation of kidney stones, and coronary calcification. Another objective of this project is to investigate whether the combined therapy can facilitate an actual reset of the Calcium-sensing receptor, and thereby de facto cure the disease.

Provided treatments

  • Drug: Cinacalcet 30 mg Tablet
  • Drug: Denosumab Inj 60 mg/ml
  • Other: Placebo tablets
  • Other: Saline Injection (Placebo)
Tris trial is registered with FDA with number: NCT03027557. The sponsor of the trial is Peter Vestergaard and it is looking for 60 volunteers for the current phase.
Official trial title:
Treatment of Primary Hyperparathyroidism With Denosumab and Cinacalcet.