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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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


Detailed Summary:

The study evaluates if short-term treatment with calcimimetics may be used for patients with PHPT as a relevant guide in the decision of when to choose parathyroid surgery, by predicting the outcome of surgical treatment.

120 ± 2 patients with primary hyperparathyroidism scheduled for parathyroid surgery will be included in the study after informed consent and will receive study medication with cinacalcet, Mimpara® 30 mgx1 for four weeks. In case of persistent hypercalcemia after two weeks of treatment with Mimpara® 30 mgx1, the dosage of Mimpara® will be increased to 60 mg daily. During the study drug treatment period, the patients will be followed closely at least once a week with clinical monitoring and control of serum ionized calcium, given the risk of side effects and hypocalcemia. If the concentration of ionized calcium in serum will decrease to a subnormal level (<1.15 mmol/l), the Mimpara® treatment will be discontinued temporarily and only reinserted in a lower dose (30 mg x 1) if the concentration of ionized calcium raises over 1.33 mmol/l. The size of the cohort has been decided after power estimations based on the results in study part A. Both groups will go through the test panel of self-rating scales described above at four occasions (Figure).

The Outcome to be registered are the changes from baseline to the end of the study medication period compared to the changes postoperatively, thus the changes between the Visit 2 to Visit 6 and the changes between Visit 2 and Visit 7 and Visit 8 respektively.

Assessments and Procedures Visit 1: Clinical examination (general condition, neck, blood pressure, cor et pulm). Screening of patients with primary hyperparathyroidism scheduled for parathyroid surgery. Patient that fulfills inclusion an
Sponsor: Karolinska University Hospital

Current Primary Outcome: Quality of life [ Time Frame: after four weeks of calcimimetic treatment and postoperatively ]

Health related quality of life measured by EORTC QLQ-C30 (total score)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Psychological well-being [ Time Frame: After four weeks of calcimimetic treatment and postoperatively ]
    Psychological well-being, evaluated with the validated form Positive States of Mind, PSOM
  • Anxiety and depression [ Time Frame: After four weeks of calcimimetic treatment and postoperatively ]
    Depression and anxiety; evaluated with the Hospital Anxiety and Depression (HAD) scale
  • Muscle strength [ Time Frame: After four weeks of calcimimetic treatment and postoperatively ]
    Leg muscle strength measured by Timed stand-test (repeated uprise from chair)
  • Biochemical data [ Time Frame: After four weeks of calcimimetic treatment and postoperatively ]
    AE/SAE recording and safety blood samples; serum levels of p-PTH, s-ionized calcium, p-total calcium, p-albumin, p-creatinine, p-phosphate, s-25-OH-D and thyroid-stimulating hormone (TSH)
  • Cognitive function [ Time Frame: after four weeks of calcimimetic treatment and postoperatively ]
    Cognitive function evaluated with Montreal cognitive assessment (MoCA-test)


Original Secondary Outcome: Same as current

Information By: Karolinska University Hospital

Dates:
Date Received: August 17, 2014
Date Started: June 2014
Date Completion: December 2016
Last Updated: October 16, 2016
Last Verified: October 2016