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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
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Inga-Lena Nilsson, Karolinska University Hospital

Study Description
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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


Condition or disease Intervention/treatment Phase
Primary Hyperparathyroidism Drug: Cinacalcet Procedure: parathyroid adenomectomy Not Applicable

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Study Design
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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

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Cinacalcet

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.

 Drug: Cinacalcet
Cinacalcet, Mimpara® 30mgx1-2 for 4 weeks
Other Names:
  • H05BX01
  • Mimpara®

Procedure: parathyroid adenomectomy
surgical removal of pathologic parathyroid tissue


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Muscle strength [ Time Frame: After four weeks of calcimimetic treatment and postoperatively ]
    Leg muscle strength measured by Timed stand-test (repeated uprise from chair)

  4. 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)

  5. Cognitive function [ Time Frame: after four weeks of calcimimetic treatment and postoperatively ]
    Cognitive function evaluated with Montreal cognitive assessment (MoCA-test)


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sweden
Karolinska University Hospital
Stockholm, Sweden, 171 76
Sponsors and Collaborators
Karolinska University Hospital
Karolinska Institutet
Investigators
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Principal Investigator: Inga-Lena Nilsson, M.D., Ph.D Karolinska UH
Principal Investigator: Inga-Lena Y Nilsson, MD, PhD Karolinska UH
More Information
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Additional Information:
Karolinska University Hospital  This link exits the ClinicalTrials.gov site Karolinska Institute  This link exits the ClinicalTrials.gov site Ethical Review Board  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Inga-Lena Nilsson, M.D., Ph.D; Assoc.prof., Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT02227264     History of Changes
Other Study ID Numbers: 2012-005374-57
First Posted: August 28, 2014    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Inga-Lena Nilsson, Karolinska University Hospital:
Primary hyperparathyroidism
Calcimimetic Agents
Parathyroid adenomectomy
Additional relevant MeSH terms:
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Calcium-Regulating Hormones and Agents
Hyperparathyroidism
Hyperparathyroidism, Primary
Parathyroid Diseases
Endocrine System Diseases
Parathyroid Hormone
 Cinacalcet
Physiological Effects of Drugs
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists