Primary HyperparathyroidismNCT02227264
Primary Hyperparathyroidism: Short-term Calcimimetics Treatment - Relevance for Parathyroid Surgery Decisions?
A study testing Cinacalcet and parathyroid adenomectomy in people with Primary Hyperparathyroidism, run by Karolinska University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Primary Hyperparathyroidism
- What is being tested?
- Cinacalcet and parathyroid adenomectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSweden
- Study dates
- Jun 2014to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary hyperparathyroidism
- Scheduled for parathyroid surgery
- Age >40
- Ability to participate in all tests included in the study model
- Signed consent
Who cannot join
- 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®
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
Read the detailed description
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 and exclusion criteria will be asked to participate in the study.
Visit 2: Informed consent is signed. Test panel of self rating scales (Quality of Life Questionnaire-Core 30 (QLQ-C30), Positive States of Mind (PSOM )and Hospital Anxiety and Depression scale (HAD), cognitive test (Montreal cognitive assessment (MoCA-Test)) and muscle strength (Timed stand test). Blood samples are drawn within 2 weeks before and analyzed for: parathyroid hormone (p-PTH), s-ionized calcium, p-total calcium, p-albumin, p-creatinine, p-phosphate, s-25-OH-D-vitamin and p-TSH. Initiation of treatment with Mimpara® 30 mg x 1. Clinical examination (general condition, blood pressure). For fertile women, a pregnancy test is demanded before enrollment.
Visit 3: Week 1 (± 2 days); blood samples for analysis of ionized calcium. History of symptoms related to hypocalcemia (paresthesias, cramps, muscle fatigue). Clinical examination when indicated (general condition, blood pressure).
Visit 4: Week 2 (± 2 days); blood samples for analysis of ionized calcium. History as above. Mimpara® continued, If the ionized calcium level is >1.33 mmol/l: increase of dosage of Mimpara® to 30 mg x 2.
Visit 5: Week 3 (± 2 days); blood samples for analysis of ionized calcium. History as above. Mimpara® treatment completed.
Visit 6 (3): Week 4 (± 2 weeks in study B); Test panel of self rating scales (QLQ-C30, PSOM and HAD), cognitive test (MoCA-Test) and muscle strength (Timed stand test). Blood samples are drawn and analyzed for: plasma (p)-PTH, serum(s)-ionized serum calcium, p-total calcium, p-albumin, p-creatinine, p-phosphate.
Visit 7 (4): Postoperative follow up, 6 (± 1 week) post surgery; Test panel of self rating scales (QLQ-C30, PSOM and HAD), cognitive test (MoCA-Test) and muscle strength (Timed stand test). Blood samples are drawn and analyzed for plasma p-PTH, s-ionized calcium, p-total calcium, p-albumin, p-creatinine, p-phosphate, s-25-OH-D-vitamin and p-TSH.
Visit 8 (5): Postoperatively, 6 months post surgery (± 3 weeks); Test panel of self rating scales (QLQ-C30, PSOM and HAD), cognitive test (MoCA-Test) and muscle strength (Timed stand test). Blood samples are drawn and analyzed for plasma (p)-PTH, s-ionized calcium, p-total calcium, p-albumin, p-creatinine, p-phosphate, s-25-OH-D-vitamin and p-TSH.
- Conditions
- Primary Hyperparathyroidism
- Being tested
- Cinacalcet, parathyroid adenomectomy
- Keywords
- Primary hyperparathyroidism, Calcimimetic Agents, Parathyroid adenomectomy
- Medical subject headings
- Hyperparathyroidism, Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CinacalcetDrug
Also called H05BX01, Mimpara®
Cinacalcet, Mimpara® 30mgx1-2 for 4 weeks
parathyroid adenomectomyProcedure or surgery
surgical removal of pathologic parathyroid tissue
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Cinacalcet; Procedure: parathyroid adenomectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive outcome in Quality of Life after parathyroidectomy
Health related quality of life measured by EORTC QLQ-C30 (total score)
Measured: after four weeks of calcimimetic treatment and postoperatively
Secondary outcomes (5)
Psychological well-being
Psychological well-being, evaluated with the validated form Positive States of Mind, PSOM
Measured: After four weeks of calcimimetic treatment and postoperatively
Anxiety and depression
Depression and anxiety; evaluated with the Hospital Anxiety and Depression (HAD) scale
Measured: After four weeks of calcimimetic treatment and postoperatively
Muscle strength
Leg muscle strength measured by Timed stand-test (repeated uprise from chair)
Measured: After four weeks of calcimimetic treatment and postoperatively
Biochemical data
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)
Measured: After four weeks of calcimimetic treatment and postoperatively
Cognitive function
Cognitive function evaluated with Montreal cognitive assessment (MoCA-test)
Measured: after four weeks of calcimimetic treatment and postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Inga-Lena Nilsson, Karolinska University Hospital
- Investigators
- Inga-Lena Nilsson, M.D., Ph.D, Principal investigator, Karolinska UHInga-Lena Y Nilsson, MD, PhD, Principal investigator, Karolinska UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02227264
- Sponsor's protocol ID
- 2012-005374-57
- Status last verified
- Aug 2024
- First submitted
- 17 Aug 2014
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 31595982
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Hyperparathyroidism: Short-term Calcimimetics Treatment - Relevance for Parathyroid Surgery Decisions?
- ClinicalTrials.gov ID
- NCT02227264
- Acronym / sponsor ID
- 2012-005374-57
- Conditions
- Primary Hyperparathyroidism
- Keywords
- Primary hyperparathyroidism, Calcimimetic Agents, Parathyroid adenomectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- Jun 2014
- Primary completion
- Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 28 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 description
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 and exclusion criteria will be asked to participate in the study.
Visit 2: Informed consent is signed. Test panel of self rating scales (Quality of Life Questionnaire-Core 30 (QLQ-C30), Positive States of Mind (PSOM )and Hospital Anxiety and Depression scale (HAD), cognitive test (Montreal cognitive assessment (MoCA-Test)) and muscle strength (Timed stand test). Blood samples are drawn within 2 weeks before and analyzed for: parathyroid hormone (p-PTH), s-ionized calcium, p-total calcium, p-albumin, p-creatinine, p-phosphate, s-25-OH-D-vitamin and p-TSH. Initiation of treatment with Mimpara® 30 mg x 1. Clinical examination (general condition, blood pressure). For fertile women, a pregnancy test is demanded before enrollment.
Visit 3: Week 1 (± 2 days); blood samples for analysis of ionized calcium. History of symptoms related to hypocalcemia (paresthesias, cramps, muscle fatigue). Clinical examination when indicated (general condition, blood pressure).
Visit 4: Week 2 (± 2 days); blood samples for analysis of ionized calcium. History as above. Mimpara® continued, If the ionized calcium level is >1.33 mmol/l: increase of dosage of Mimpara® to 30 mg x 2.
Visit 5: Week 3 (± 2 days); blood samples for analysis of ionized calcium. History as above. Mimpara® treatment completed.
Visit 6 (3): Week 4 (± 2 weeks in study B); Test panel of self rating scales (QLQ-C30, PSOM and HAD), cognitive test (MoCA-Test) and muscle strength (Timed stand test). Blood samples are drawn and analyzed for: plasma (p)-PTH, serum(s)-ionized serum calcium, p-total calcium, p-albumin, p-creatinine, p-phosphate.
Visit 7 (4): Postoperative follow up, 6 (± 1 week) post surgery; Test panel of self rating scales (QLQ-C30, PSOM and HAD), cognitive test (MoCA-Test) and muscle strength (Timed stand test). Blood samples are drawn and analyzed for plasma p-PTH, s-ionized calcium, p-total calcium, p-albumin, p-creatinine, p-phosphate, s-25-OH-D-vitamin and p-TSH.
Visit 8 (5): Postoperatively, 6 months post surgery (± 3 weeks); Test panel of self rating scales (QLQ-C30, PSOM and HAD), cognitive test (MoCA-Test) and muscle strength (Timed stand test). Blood samples are drawn and analyzed for plasma (p)-PTH, s-ionized calcium, p-total calcium, p-albumin, p-creatinine, p-phosphate, s-25-OH-D-vitamin and p-TSH.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cinacalcet | Experimental | Drug: Cinacalcet, Procedure: parathyroid adenomectomyCinacalcet, 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary hyperparathyroidism
- Scheduled for parathyroid surgery
- Age >40
- Ability to participate in all tests included in the study model
- Signed consent
Key exclusion criteria (12 listed)
- Pregnancy
- Breast feeding
- Fertile woman not using contraceptives (IUD or pills)
- Impaired kidney function, GFR < 40 ml/min
- Intolerance to Mimpara®
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CinacalcetAlso: H05BX01, Mimpara®Cinacalcet, Mimpara® 30mgx1-2 for 4 weeks | Drug | Cinacalcet |
| parathyroid adenomectomysurgical removal of pathologic parathyroid tissue | Procedure or surgery | Cinacalcet |
Primary outcome
Predictive outcome in Quality of Life after parathyroidectomy
Time frame: after four weeks of calcimimetic treatment and postoperatively
Health related quality of life measured by EORTC QLQ-C30 (total score)
5 secondary outcomes
Psychological well-being
Time frame: After four weeks of calcimimetic treatment and postoperatively
Anxiety and depression
Time frame: After four weeks of calcimimetic treatment and postoperatively
Muscle strength
Time frame: After four weeks of calcimimetic treatment and postoperatively
Biochemical data
Time frame: After four weeks of calcimimetic treatment and postoperatively
Cognitive function
Time frame: after four weeks of calcimimetic treatment and postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Derived from this study: PubMed 31595982Koman 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.
- Karolinska University HospitalLink provided by the sponsor.
- Karolinska InstituteLink provided by the sponsor.
- Ethical Review BoardLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Inga-Lena Nilsson, M.D., Ph.D principal investigator
Karolinska UH
Inga-Lena Y Nilsson, MD, PhD principal investigator
Karolinska UH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cinacalcet and parathyroid adenomectomy in people with Primary Hyperparathyroidism, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive outcome in Quality of Life after parathyroidectomy (time frame: after four weeks of calcimimetic treatment and postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02227264, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.