NCT02227264

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 28, 2014

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

August 6, 2024

Status Verified

August 1, 2024

Enrollment Period

7.5 years

First QC Date

August 17, 2014

Last Update Submit

August 5, 2024

Conditions

Primary Hyperparathyroidism

Keywords

Primary hyperparathyroidismCalcimimetic AgentsParathyroid adenomectomy

Outcome Measures

Primary Outcomes (1)

  • Predictive outcome in Quality of Life after parathyroidectomy

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

    after four weeks of calcimimetic treatment and postoperatively

Secondary Outcomes (5)

  • Psychological well-being

    After four weeks of calcimimetic treatment and postoperatively

  • Anxiety and depression

    After four weeks of calcimimetic treatment and postoperatively

  • Muscle strength

    After four weeks of calcimimetic treatment and postoperatively

  • Biochemical data

    After four weeks of calcimimetic treatment and postoperatively

  • Cognitive function

    after four weeks of calcimimetic treatment and postoperatively

Study Arms (1)

Cinacalcet

EXPERIMENTAL

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: CinacalcetProcedure: parathyroid adenomectomy

Interventions

CinacalcetDRUG

Cinacalcet, Mimpara® 30mgx1-2 for 4 weeks

Also known as: H05BX01, Mimpara®
Cinacalcet
parathyroid adenomectomyPROCEDURE

surgical removal of pathologic parathyroid tissue

Cinacalcet

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary hyperparathyroidism
  • Scheduled for parathyroid surgery
  • Age \>40
  • Ability to participate in all tests included in the study model
  • Signed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, 171 76, Sweden

Location

Related Publications (1)

  • Koman A, Ohlsson S, Branstrom R, Pernow Y, Branstrom R, Nilsson IL. Short-term medical treatment of hypercalcaemia in primary hyperparathyroidism predicts symptomatic response after parathyroidectomy. Br J Surg. 2019 Dec;106(13):1810-1818. doi: 10.1002/bjs.11319. Epub 2019 Oct 9.

    PMID: 31595982DERIVED

Related Links

MeSH Terms

Conditions

Hyperparathyroidism, Primary

Interventions

Cinacalcet

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Inga-Lena Nilsson, M.D., Ph.D

    Karolinska UH

    PRINCIPAL INVESTIGATOR

  • Inga-Lena Y Nilsson, MD, PhD

    Karolinska UH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D; Assoc.prof.

Study Record Dates

First Submitted

August 17, 2014

First Posted

August 28, 2014

Study Start

June 1, 2014

Primary Completion

December 1, 2021

Study Completion

December 31, 2021

Last Updated

August 6, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)