Trial · NCT00261950
Bone Biopsy Study For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease
NCT00261950, Phase 2, Completed, Amgen; results first posted 2013-12-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Bone Biopsy Study For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease. Trials, record NCT00261950. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00261950
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bone Biopsy Study For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease
- NCT number
- NCT00261950
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 110 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Secondary Hyperparathyroidism
- Interventions
- Sensipar (Cinacalcet HCl)
- First posted
- 2005-12-06
- Last updated
- 2014-07-21
- Results first posted
- 2013-12-04
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to End of Study in Bone Formation Rate (BFR) | Baseline to week 52 | |
| Secondary | Percent Change From Baseline in Serum Calcium During the Efficacy Assessment Phase (EAP) | Baseline to weeks 40-52 | |
| Secondary | Percent Change From Baseline in Serum Phosphorus During the Efficacy Assessment Phase (EAP) | Baseline to weeks 40-52 | |
| Secondary | Percent Change From Baseline in Ca x P During the Efficacy Assessment Phase (EAP) | Baseline to weeks 40-52 | |
| Secondary | Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BALP) at Week 52 | Baseline to week 52 | |
| Secondary | Percent Change From Baseline in N - Telopeptide (NTx) at Week 52 | Baseline to week 52 | |
| Secondary | Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Assessment Phase (EAP) | Baseline to weeks 40-52 | |
| Secondary | Change From Baseline to End of Study in Osteoblast Perimeter (Osteoblast Perimeter/Osteoid Perimeter) | Baseline to week 52 | Osteoblast Perimeter was calculated as "Osteoblast Perimeter/Osteoid Perimeter \* 100" |
| Secondary | Change From Baseline to End of Study in Osteoclast Perimeter (Osteoclast Perimeter/Eroded Perimeter) | Baseline to week 52 | Osteoclast Perimeter was calculated as "Osteoclast Perimeter/Eroded Perimeter \* 100" |
| Secondary | Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area | Baseline to week 52 | Categorisation at each timepoint was based on fibrosis area as a percentage of tissue area (Fibrosis Area/Tissue Area \* 100) |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Percent Change From Baseline in Serum Calcium During the Efficacy Assessment Phase (EAP) | Baseline to weeks 40-52 | Enrolled subjects with serum calcium during the Efficacy Assessment Phase (EAP) | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Serum Phosphorus During the Efficacy Assessment Phase (EAP) | Baseline to weeks 40-52 | Enrolled subjects with serum phosphorus during the Efficacy Assessment Phase (EAP) | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Ca x P During the Efficacy Assessment Phase (EAP) | Baseline to weeks 40-52 | Enrolled subjects with Ca x P during the Efficacy Assessment Phase (EAP) | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BALP) at Week 52 | Baseline to week 52 | Enrolled subjects with BALP at week 52 | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in N - Telopeptide (NTx) at Week 52 | Baseline to week 52 | Enrolled subjects with NTx at week 52 | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Assessment Phase (EAP) | Baseline to weeks 40-52 | Enrolled subjects with PTH during the Efficacy Assessment Phase (EAP) | percent change | MEAN |
| PRIMARY | Change From Baseline to End of Study in Bone Formation Rate (BFR) | Baseline to week 52 | Enrolled subjects with bone biopsy at week 52 | μm^2/mm^2/day | MEAN |
| SECONDARY | Change From Baseline to End of Study in Osteoblast Perimeter (Osteoblast Perimeter/Osteoid Perimeter) | Baseline to week 52 | Enrolled subjects with Osteoblast Perimeter at week 52 | percentage of osteoid perimeter | MEAN |
| SECONDARY | Change From Baseline to End of Study in Osteoclast Perimeter (Osteoclast Perimeter/Eroded Perimeter) | Baseline to week 52 | Enrolled subjects with Osteoclast Perimeter at week 52 | percentage of eroded perimeter | MEAN |
| SECONDARY | Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area | Baseline to week 52 | Enrolled subjects with Fibrosis Area/Tissue Area at week 52 | participants | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group37
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Serum Calcium During the Efficacy Assessment Phase (EAP) | Cinacalcet | -6.5 | Standard Error 1.1 | percent change | |
| Percent Change From Baseline in Serum Phosphorus During the Efficacy Assessment Phase (EAP) | Cinacalcet | -1.1 | Standard Error 2.9 | percent change | |
| Percent Change From Baseline in Ca x P During the Efficacy Assessment Phase (EAP) | Cinacalcet | -6.9 | Standard Error 3.1 | percent change | |
| Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BALP) at Week 52 | Cinacalcet | 6.6 | Standard Error 12.7 | percent change | |
| Percent Change From Baseline in N - Telopeptide (NTx) at Week 52 | Cinacalcet | -14.0 | Standard Error 14.7 | percent change | |
| Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Assessment Phase (EAP) | Cinacalcet | -41.6 | Standard Error 4.4 | percent change | |
| Change From Baseline to End of Study in Bone Formation Rate (BFR) | Cinacalcet | -488 | Standard Error 73 | μm^2/mm^2/day | |
| Change From Baseline to End of Study in Osteoblast Perimeter (Osteoblast Perimeter/Osteoid Perimeter) | Cinacalcet | -4.3 | Standard Error 1.4 | percentage of osteoid perimeter | |
| Change From Baseline to End of Study in Osteoclast Perimeter (Osteoclast Perimeter/Eroded Perimeter) | Cinacalcet | -2.7 | Standard Error 1.5 | percentage of eroded perimeter | |
| Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area | Cinacalcet | Baseline 0% End of Study 0% | 3 | participants |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cinacalcet | 110 | |
| Overall Study | COMPLETED | Cinacalcet | 84 | |
| Overall Study | NOT COMPLETED | Cinacalcet | 26 |
Source ClinicalTrials.gov
Adverse events131
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 | Abdominal pain | Gastrointestinal disorders | Cinacalcet | 7 | 110 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Cinacalcet | 8 | 110 | |
| other | Diarrhoea | Gastrointestinal disorders | Cinacalcet | 22 | 110 | |
| other | Dyspepsia | Gastrointestinal disorders | Cinacalcet | 9 | 110 | |
| other | Nausea | Gastrointestinal disorders | Cinacalcet | 28 | 110 | |
| other | Vomiting | Gastrointestinal disorders | Cinacalcet | 23 | 110 | |
| other | Oedema peripheral | General disorders | Cinacalcet | 6 | 110 | |
| other | Pyrexia | General disorders | Cinacalcet | 6 | 110 | |
| other | Bronchitis | Infections and infestations | Cinacalcet | 8 | 110 | |
| other | Upper respiratory tract infection | Infections and infestations | Cinacalcet | 6 | 110 |
1 to 10 of 131Source ClinicalTrials.gov
See all 131 adverse eventsAdverse 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 | 84 | 110 |
| Total, serious adverse events | Cinacalcet | 45 | 110 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25337774 | 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/NCT00261950
GET https://conductscience.org/api/trials/v1/NCT00261950/results?page=2