Primary Hyperparathyroidism: Short-term Calcimimetics Treatment - Relevance for Parathyroid Surgery Decisions?
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|ClinicalTrials.gov Identifier: NCT02227264|
Recruitment Status : Active, not recruiting
First Posted : August 28, 2014
Last Update Posted : February 28, 2019
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
|Condition or disease||Intervention/treatment||Phase|
|Primary Hyperparathyroidism||Drug: Cinacalcet Procedure: parathyroid adenomectomy||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||123 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Primary Hyperparathyroidism: Short-term Calcimimetics Treatment - Relevance for Parathyroid Surgery Decisions?|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
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.
Second intervention: Parathyroid adenomectomy.
Cinacalcet, Mimpara® 30mgx1-2 for 4 weeks
Procedure: parathyroid adenomectomy
surgical removal of pathologic parathyroid tissue
- 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)
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02227264
|Karolinska University Hospital|
|Stockholm, Sweden, 171 76|
|Principal Investigator:||Inga-Lena Nilsson, M.D., Ph.D||Karolinska UH|
|Principal Investigator:||Inga-Lena Y Nilsson, MD, PhD||Karolinska UH|