Treatment of Primary Hyperparathyroidism With Denosumab and Cinacalcet.

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.

Conditions

• Primary Hyperparathyroidism
• Parathyroid Adenoma
• Parathyroid Hyperplasia

Interventions

DRUG

Cinacalcet 30 mg Tablet

Participants in one arm will receive 30 mg cinacalcet each day.

DRUG

Denosumab Inj 60 mg/ml

Participants in two arms will receive 60 mg Denosumab biannually.

OTHER

Placebo tablets

Participants in two arms will receive one placebo-tablet each day.

OTHER

Saline Injection (Placebo)

Participants in one arm will receive saline injections as placebo for denosumab.

Sponsors & Collaborators

• Aalborg University

  collaborator OTHER

• Peter Vestergaard

  lead OTHER

Principal Investigators

• Julius Simoni Leere, MD · Aalborg University and Aalborg University Hospital

• Peter Vestergaard, DMSc · Aalborg University and Aalborg University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-03-01

Primary Completion

2019-04-01

Completion

2019-09-12

FDA Drug

Yes

Countries

• Denmark

Study Locations