Hyperparathyroidism, PrimaryNCT00928408

PRIMARA: A Prospective Descriptive Observational Study to Review Mimpara (Cinacalcet) Use in Patients With Primary Hyperparathyroidism in Clinical Practice

An observational study of Hyperparathyroidism, Primary, run by Amgen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a multicentre, descriptive observational study of adult patients with primary HPT receiving cinacalcet in clinical practice in a number of countries in Europe. Patients will be enrolled within 1 month of initiating cinacalcet treatment, and data will be collected prospectively for up to 1 year from initiation. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hyperparathyroidism, Primary
What is being tested?: Cinacalcet
How many people: 305 participants
Where: No sites listed yet
Study dates: Oct 2009to Feb 2012
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Adult patients with primary HPT receiving cinacalcet in clinical practice

Who may be able to join

at least 18 years of age at the time of first administration of cinacalcet
patients with primary HPT who have initiated cinacalcet within 1 month before enrolment in the study
provision of informed consent (if required)

Who cannot join

previous use of cinacalcet (other than within 1 month before enrolment)
diagnosed secondary HPT
other known aetiology of hypercalcaemia (eg, sarcoidosis, tuberculosis)

About this study

Conditions: Hyperparathyroidism, Primary
Being tested: Cinacalcet
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

Study groups in NCT00928408
Study group	Role	What they receive
Cinacalcet		Not described Receives: Drug: Cinacalcet

What is being measured

The primary outcome is the main question the study is designed to answer.

Cinacalcet Dose
Cinacalcet dose at initiation of treatment
Measured: Initiation of treatment
Cinacalcet Dose
Cinacalcet dose at Month 3
Measured: Month 3
Cinacalcet Dose
Cinacalcet dose at Month 6
Measured: Month 6
Cinacalcet Dose
Cinacalcet dose at Month 12
Measured: Month 12
Cinacalcet Dose
Cinacalcet dose at end of treatment (last dose received)
Measured: Up to Month 12
Cinacalcet Dosing Frequency
Cinacalcet dosing frequency at initiation of treatment
Measured: Initiation of treatment
Cinacalcet Dosing Frequency
Cinacalcet dosing frequency at Month 3
Measured: Month 3
Cinacalcet Dosing Frequency
Cinacalcet dosing frequency at Month 6
Measured: Month 6
Cinacalcet Dosing Frequency
Cinacalcet dosing frequency at Month 12
Measured: Month 12
Cinacalcet Dosing Frequency
Cinacalcet dosing frequency at end of treatment
Measured: Up to Month 12
Occurrence of a Change in Cinacalcet Dose or Frequency During the First 3 Months After Initiation
Measured: Initiation to Month 3
Occurrence of a Change in Cinacalcet Dose or Frequency >3 to 6 Months After Initiation
Measured: >3 to 6 months after initiation
Occurrence of a Change in Cinacalcet Dose or Frequency >6 Months After Initiation
Measured: >6 months after initiation
Duration of Exposure to Cinacalcet
Time from first dose to last non-zero dose on study
Measured: 12 months
Achievement of a Reduction From Baseline of Albumin-corrected Serum Calcium ≥ 0.25 mmol/L (1 mg/dL) at Month 3
Baseline is pre-cinacalcet.
Measured: Month 3
Achievement of a Reduction From Baseline of Albumin-corrected Serum Calcium ≥ 0.25 mmol/L (1 mg/dL) at Month 6
Baseline is pre-cinacalcet.
Measured: Month 6
Achievement of a Reduction From Baseline of Albumin-corrected Serum Calcium ≥ 0.25 mmol/L (1 mg/dL) at Month 12
Baseline is pre-cinacalcet.
Measured: Month 12
Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 3
Measured: Month 3
Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 6
Measured: Month 6
Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 12
Measured: Month 12
Change From Baseline to Month 3 in Albumin-corrected Serum Calcium
Measured: Baseline to Month 3
Change From Baseline to Month 6 in Albumin-corrected Serum Calcium
Measured: Baseline to Month 6
Change From Baseline to Month 12 in Albumin-corrected Serum Calcium
Measured: Baseline to Month 12
Percent Change From Baseline to Month 12 in Bone Mineral Density (g/cm^2). Anatomic Site: Femoral Neck; Densitometer: Hologic
Results only shown where >10 patients have data
Measured: Baseline to Month 12
Percent Change From Baseline to Month 12 in Bone Mineral Density (g/cm^2). Anatomic Site: Lumbar Spine; Densitometer: Hologic
Results only shown where >10 patients have data
Measured: Baseline to Month 12
Reason for Prescribing Cinacalcet
Measured: Initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2009Feb 2012

First posted26 Jun 2009 (estimated)
Study startOct 2009
Primary completionDec 2011
Study completionFeb 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hyperparathyroidism, PrimaryStudies of the same condition, open and under way.
More trials run by AmgenThe 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: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 305 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00928408
Sponsor's protocol ID: 20070363
Other IDs: PRIMARA
Status last verified: Sep 2015
First submitted: 25 Jun 2009
Last updated: 1 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Langdahl BL, Ralston SH. Diagnosis and management of primary hyperparathyroidism in Europe. QJM. 2012 Jun;105(6):519-25. doi: 10.1093/qjmed/hcr225. Epub 2012 May 7.
PubMed 22566664

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Natural History Study of Parathyroid Disorders
Parathyroid Cancer, Primary Hyperparathyroidism
Not yet recruiting
Treating PHPT With the nPulse™ Vybrance™ PE System
Primary Hyperparathyroidism
RecruitingEarly Phase 1
Flurpiridaz F-18 PET/CT Imaging for Detecting Parathyroid Adenomas
Hyperparathyroidism
RecruitingPhase 2/3
Accuracy of 18F-Fluorocholine PET/MR and NeuroEXPLORER PET/CT Imaging for Localization of Parathyroid Tumors
Primary Hyperparathyroidism, Parathyroid Cancer
Enrolling by invitationObservational study
Parathyroid Adenoma Detection With Rubidium-82 Imaging
Parathyroid Adenomas, Hyperparathyroidism, Primary

All Hyperparathyroidism, Primary trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PRIMARA: A Prospective Descriptive Observational Study to Review Mimpara (Cinacalcet) Use in Patients With Primary Hyperparathyroidism in Clinical Practice
ClinicalTrials.gov ID: NCT00928408
Acronym / sponsor ID: 20070363
Conditions: Hyperparathyroidism, Primary
Study type: Observational
Recruitment status: Completed
Enrolment: 305 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: Oct 2009
Primary completion: Dec 2011 (actual)
Study completion: Feb 2012 (actual)
First posted: 26 Jun 2009 (estimated)
Results: Posted 14 Nov 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Cinacalcet	–	Drug: Cinacalcet

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adult patients with primary HPT receiving cinacalcet in clinical practice

Key inclusion criteria (3 listed)

at least 18 years of age at the time of first administration of cinacalcet
patients with primary HPT who have initiated cinacalcet within 1 month before enrolment in the study
provision of informed consent (if required)

Key exclusion criteria (3 listed)

previous use of cinacalcet (other than within 1 month before enrolment)
diagnosed secondary HPT
other known aetiology of hypercalcaemia (eg, sarcoidosis, tuberculosis)

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
Cinacalcet	Drug	Cinacalcet

Primary outcome

Cinacalcet Dose
Time frame: Initiation of treatment
Cinacalcet dose at initiation of treatment
Cinacalcet Dose
Time frame: Month 3
Cinacalcet dose at Month 3
Cinacalcet Dose
Time frame: Month 6
Cinacalcet dose at Month 6
Cinacalcet Dose
Time frame: Month 12
Cinacalcet dose at Month 12
Cinacalcet Dose
Time frame: Up to Month 12
Cinacalcet dose at end of treatment (last dose received)
Cinacalcet Dosing Frequency
Time frame: Initiation of treatment
Cinacalcet dosing frequency at initiation of treatment
Cinacalcet Dosing Frequency
Time frame: Month 3
Cinacalcet dosing frequency at Month 3
Cinacalcet Dosing Frequency
Time frame: Month 6
Cinacalcet dosing frequency at Month 6
Cinacalcet Dosing Frequency
Time frame: Month 12
Cinacalcet dosing frequency at Month 12
Cinacalcet Dosing Frequency
Time frame: Up to Month 12
Cinacalcet dosing frequency at end of treatment
Occurrence of a Change in Cinacalcet Dose or Frequency During the First 3 Months After Initiation
Time frame: Initiation to Month 3
Occurrence of a Change in Cinacalcet Dose or Frequency >3 to 6 Months After Initiation
Time frame: >3 to 6 months after initiation
Occurrence of a Change in Cinacalcet Dose or Frequency >6 Months After Initiation
Time frame: >6 months after initiation
Duration of Exposure to Cinacalcet
Time frame: 12 months
Time from first dose to last non-zero dose on study
Achievement of a Reduction From Baseline of Albumin-corrected Serum Calcium ≥ 0.25 mmol/L (1 mg/dL) at Month 3
Time frame: Month 3
Baseline is pre-cinacalcet.
Achievement of a Reduction From Baseline of Albumin-corrected Serum Calcium ≥ 0.25 mmol/L (1 mg/dL) at Month 6
Time frame: Month 6
Baseline is pre-cinacalcet.
Achievement of a Reduction From Baseline of Albumin-corrected Serum Calcium ≥ 0.25 mmol/L (1 mg/dL) at Month 12
Time frame: Month 12
Baseline is pre-cinacalcet.
Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 3
Time frame: Month 3
Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 6
Time frame: Month 6
Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 12
Time frame: Month 12
Change From Baseline to Month 3 in Albumin-corrected Serum Calcium
Time frame: Baseline to Month 3
Change From Baseline to Month 6 in Albumin-corrected Serum Calcium
Time frame: Baseline to Month 6
Change From Baseline to Month 12 in Albumin-corrected Serum Calcium
Time frame: Baseline to Month 12
Percent Change From Baseline to Month 12 in Bone Mineral Density (g/cm^2). Anatomic Site: Femoral Neck; Densitometer: Hologic
Time frame: Baseline to Month 12
Results only shown where >10 patients have data
Percent Change From Baseline to Month 12 in Bone Mineral Density (g/cm^2). Anatomic Site: Lumbar Spine; Densitometer: Hologic
Time frame: Baseline to Month 12
Results only shown where >10 patients have data
Reason for Prescribing Cinacalcet
Time frame: Initiation

Results and safety

Results posted to the registry on 14 Nov 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cinacalcet	305	282

Primary outcome: Cinacalcet Dose

Time frame: Initiation of treatment. Mean (95% Confidence Interval). Unit: mg/day

Measure	Cinacalcet n = 303
Value	43.9 (0.9)

Population analysed: Full Analysis Set

Primary outcome: Cinacalcet Dose

Time frame: Month 3. Mean (95% Confidence Interval). Unit: mg/day

Measure	Cinacalcet n = 255
Value	48.7 (0.9)

Population analysed: Full Analysis Set - Participants with Observed Data

Primary outcome: Cinacalcet Dose

Time frame: Month 6. Mean (95% Confidence Interval). Unit: mg/day

Measure	Cinacalcet n = 233
Value	48.9 (0.9)

Population analysed: Full Analysis Set - Participants with Observed Data

Primary outcome: Cinacalcet Dose

Time frame: Month 12. Mean (95% Confidence Interval). Unit: mg/day

Measure	Cinacalcet n = 219
Value	51.3 (0.9)

Population analysed: Full Analysis Set - Participants with Observed Data

Adverse events

Time frame: 12 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cinacalcet	2 of 303 (0.7%)	41 of 303 (13.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22566664Langdahl BL, Ralston SH. Diagnosis and management of primary hyperparathyroidism in Europe. QJM. 2012 Jun;105(6):519-25. doi: 10.1093/qjmed/hcr225. Epub 2012 May 7.
AmgenTrials clinical trials websiteLink provided by the sponsor.

Related trials for Hyperparathyroidism, Primary

RecruitingObservational study
Natural History Study of Parathyroid Disorders
Parathyroid Cancer, Primary Hyperparathyroidism
Not yet recruiting
Treating PHPT With the nPulse™ Vybrance™ PE System
Primary Hyperparathyroidism
RecruitingEarly Phase 1
Flurpiridaz F-18 PET/CT Imaging for Detecting Parathyroid Adenomas
Hyperparathyroidism
RecruitingPhase 2/3
Accuracy of 18F-Fluorocholine PET/MR and NeuroEXPLORER PET/CT Imaging for Localization of Parathyroid Tumors
Primary Hyperparathyroidism, Parathyroid Cancer
Enrolling by invitationObservational study
Parathyroid Adenoma Detection With Rubidium-82 Imaging
Parathyroid Adenomas, Hyperparathyroidism, Primary

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.

MD study director

Amgen

Questions about this trial

What is this clinical trial studying?

An observational study of Hyperparathyroidism, Primary, run by Amgen.

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 3 inclusion and 3 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 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 14 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Cinacalcet Dose (time frame: Initiation of treatment). The study lists 26 primary outcomes in all. 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 NCT00928408, 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 1 Aug 2018.