Trial · NCT00928408
PRIMARA: A Prospective Descriptive Observational Study to Review Mimpara (Cinacalcet) Use in Patients With Primary Hyperparathyroidism in Clinical Practice
NCT00928408, Completed, Amgen; results first posted 2013-11-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. PRIMARA: A Prospective Descriptive Observational Study to Review Mimpara (Cinacalcet) Use in Patients With Primary Hyperparathyroidism in Clinical Practice. Trials, record NCT00928408. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00928408
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PRIMARA: A Prospective Descriptive Observational Study to Review Mimpara (Cinacalcet) Use in Patients With Primary Hyperparathyroidism in Clinical Practice
- NCT number
- NCT00928408
- Status
- Completed
- Enrollment
- 305 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Hyperparathyroidism, Primary
- Interventions
- Cinacalcet
- First posted
- 2009-06-26
- Last updated
- 2018-08-01
- Results first posted
- 2013-11-14
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cinacalcet Dose | Initiation of treatment | Cinacalcet dose at initiation of treatment |
| Primary | Cinacalcet Dose | Month 3 | Cinacalcet dose at Month 3 |
| Primary | Cinacalcet Dose | Month 6 | Cinacalcet dose at Month 6 |
| Primary | Cinacalcet Dose | Month 12 | Cinacalcet dose at Month 12 |
| Primary | Cinacalcet Dose | Up to Month 12 | Cinacalcet dose at end of treatment (last dose received) |
| Primary | Cinacalcet Dosing Frequency | Initiation of treatment | Cinacalcet dosing frequency at initiation of treatment |
| Primary | Cinacalcet Dosing Frequency | Month 3 | Cinacalcet dosing frequency at Month 3 |
| Primary | Cinacalcet Dosing Frequency | Month 6 | Cinacalcet dosing frequency at Month 6 |
| Primary | Cinacalcet Dosing Frequency | Month 12 | Cinacalcet dosing frequency at Month 12 |
| Primary | Cinacalcet Dosing Frequency | Up to Month 12 | Cinacalcet dosing frequency at end of treatment |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cinacalcet Dose | Initiation of treatment | Full Analysis Set | mg/day | MEAN |
| PRIMARY | Cinacalcet Dose | Month 3 | Full Analysis Set - Participants with Observed Data | mg/day | MEAN |
| PRIMARY | Cinacalcet Dose | Month 6 | Full Analysis Set - Participants with Observed Data | mg/day | MEAN |
| PRIMARY | Cinacalcet Dose | Month 12 | Full Analysis Set - Participants with Observed Data | mg/day | MEAN |
| PRIMARY | Cinacalcet Dose | Up to Month 12 | Full Analysis Set | mg/day | MEAN |
| PRIMARY | Cinacalcet Dosing Frequency | Initiation of treatment | Full Analysis Set | Participants | NUMBER |
| PRIMARY | Cinacalcet Dosing Frequency | Month 3 | Full Analysis Set - Participants with Observed Data | Participants | NUMBER |
| PRIMARY | Cinacalcet Dosing Frequency | Month 6 | Full Analysis Set - Participants with Observed Data | Participants | NUMBER |
| PRIMARY | Cinacalcet Dosing Frequency | Month 12 | Full Analysis Set - Participants with Observed Data | Participants | NUMBER |
| PRIMARY | Cinacalcet Dosing Frequency | Up to Month 12 | Full Analysis Set | Participants | NUMBER |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group57
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cinacalcet Dose | Cinacalcet | 43.9 | 95% Confidence Interval 0.9 | mg/day | |
| Cinacalcet Dose | Cinacalcet | 48.7 | 95% Confidence Interval 0.9 | mg/day | |
| Cinacalcet Dose | Cinacalcet | 48.9 | 95% Confidence Interval 0.9 | mg/day | |
| Cinacalcet Dose | Cinacalcet | 51.3 | 95% Confidence Interval 0.9 | mg/day | |
| Cinacalcet Dose | Cinacalcet | 53.1 | 95% Confidence Interval 0.9 | mg/day | |
| Cinacalcet Dosing Frequency | Cinacalcet | Once a day | 169 | 0.9 | Participants |
| Cinacalcet Dosing Frequency | Cinacalcet | Twice a day | 134 | Participants | |
| Cinacalcet Dosing Frequency | Cinacalcet | Once a day | 133 | 0.9 | Participants |
| Cinacalcet Dosing Frequency | Cinacalcet | Twice a day | 107 | Participants | |
| Cinacalcet Dosing Frequency | Cinacalcet | Three times a day | 4 | Participants |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cinacalcet | 305 | |
| Overall Study | Full Analysis Set | Cinacalcet | 303 | |
| Overall Study | COMPLETED | Cinacalcet | 282 | |
| Overall Study | NOT COMPLETED | Cinacalcet | 23 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Cinacalcet | 41 | 303 | |
| serious | Hypocalcaemia | Metabolism and nutrition disorders | Cinacalcet | 1 | 303 | |
| serious | Muscle spasms | Musculoskeletal and connective tissue disorders | Cinacalcet | 1 | 303 | |
| serious | Circulatory collapse | Vascular disorders | Cinacalcet | 1 | 303 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cinacalcet | ||
| Total, other adverse events | Cinacalcet | 41 | 303 |
| Total, serious adverse events | Cinacalcet | 2 | 303 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22566664 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00928408
GET https://conductscience.org/api/trials/v1/NCT00928408/registered?page=2