Treatment of Primary Hyperparathyroidism With Denosumab and Cinacalcet.

• Status: Completed
• Trial end date: 2019-09-12
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peter Vestergaard
• Collaborator: Aalborg University
• Treatments: Cinacalcet; Cinacalcet Hydrochloride; Denosumab

Criteria

Inclusion Criteria:

• Men and women of 18 years of age or older.

• T-score by Dual X-ray Absorptiometry (DXA) between -1,0 og -3,5

• Patients from The North Jutland Region diagnosed with primary hyperparathyroidism at the Department of Endocrinology, Aalborg University Hospital. (Hypercalcaemia measured at two different time-points and simultaneous elevated/inappropriately high PTH, and exclusion of differential diagnosis.)

Exclusion Criteria:

• Medical history of diseases leading to hypercalcaemia other than Primary Hyperparathyroidism.

• Patients being treated with Denosumab or Cinacalcet prior to inclusion or previously treated with Denosumab or Cinacalcet.

• Moderately - Severely decreased liver function (alanine aminotransferase >250u/l, gamma-glutamyl transferase>150u/l, Bilirubin >30)

• Acute myocardial infarction or apoplexia in the 3 months before inclusion.

• Medical record of heart failure

• Risk factors of prolonged corrected QT interval (QTc).

• Open lesions from oral surgery.

• Primary diseases of the bone other than osteoporosis.

• Patients suffering from kidney disease or renal failure.

• Patients under treatment with thiazide or lithium.

• Medical record of generalized seizures or epilepsy.

• Active malignant disease.

• Known allergies towards the specified medicinal products (IMPs).

• Pregnancy or breastfeeding.

• Fertile women who do not agree to the usage of effective contraception.

• Other circumstances, evaluated by the responsible investigator, making the subject unsuitable for participation.