Overview

Primary Hyperparathyroidism: Short-term Calcimimetics Treatment - Relevance for Parathyroid Surgery Decisions?

Status:
Active, not recruiting
Trial end date:
2021-12-01
Target enrollment:
0
Participant gender:
All
Summary
Patients with primary hyperparathyroidism (pHPT) often present with fatigue, psychological and cognitive symptoms. Improvement in these symptoms after parathyroid adenomectomy (PTX) has been reported. But physicians lack a method to attribute the symptoms to pHPT and to predict the reversibility after PTX. This study aims to evaluate short-term calcimimetic treatment as a tool for predicting the outcome of PTX on muscle strength, quality of life, psychological symptoms, and cognitive function in patients with pHPT. Material and Methods: 118 patients scheduled for PTX at Karolinska University Hospital, Sweden, will have a four week treatment with calcimimetics (Mimpara®) before undergoing surgery. Biochemicals, muscle strength, quality of life, psychological symptoms and cognitive function will be analysed at baseline, after four week follow-up and postoperatively. Hypothesis: The outcome of short-term calcimimetic treatment can predict the outcome of PTX on muscle strength, quality of life, psychological symptoms, and cognitive function in patients with pHPT
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Karolinska University Hospital
Collaborator:
Karolinska Institutet
Treatments:
Cinacalcet
Cinacalcet Hydrochloride
Parathyroid Hormone
Criteria
Inclusion Criteria:

- Primary hyperparathyroidism

- Scheduled for parathyroid surgery

- Age >40

- Ability to participate in all tests included in the study model

- Signed consent

Exclusion Criteria:

- Pregnancy

- Breast feeding

- Fertile woman not using contraceptives (IUD or pills)

- Impaired kidney function, GFR < 40 ml/min

- Intolerance to Mimpara®

- Previously treated with Mimpara®

- Participating in other ongoing clinical study

- Epilepsy

- Severe hepatic impairment

- Hypotension

- Heart failure (NYHA class 3-4, symptoms with minimal exertion)

- Medication with ketoconazole (oral) or tricyclic antidepressants