Trial · NCT00396279
Safety and Efficacy Study of Denosumab in Patients With Recurrent or Unresectable Giant Cell Tumor of Bone
NCT00396279, Phase 2, Completed, Amgen; results first posted 2014-03-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy Study of Denosumab in Patients With Recurrent or Unresectable Giant Cell Tumor of Bone. Trials, record NCT00396279. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00396279
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of Denosumab in Patients With Recurrent or Unresectable Giant Cell Tumor of Bone
- NCT number
- NCT00396279
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 37 participants, actual
- Lead sponsor
- Amgen
- Conditions
- GCT, Giant Cell Tumor of Bone
- Interventions
- Denosumab, Calcium/Vitamin D
- First posted
- 2006-11-06
- Last updated
- 2022-11-08
- Results first posted
- 2014-03-05
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Giant Cell Tumor Response | From enrollment until 25 weeks | A treatment response was defined for participants with tissue samples obtained and measured by histopathology as: • at least 90% elimination of giant cells relative to Baseline, or • complete elimination of giant cells in cases where giant cells represent \< 5% of tumor cells. A response was defined for participants who have only radiographs (histopathology not available) as lack of progression of the target lesion at week 25 by radiographic measurements compared with Baseline. For participants with both a core biopsy and resected tissue obtained, the sample closest to week 25 was used in the analysis. |
| Secondary | Percent Change From Baseline in Urinary N-telopeptide Corrected for Urine Creatinine | Baseline and Weeks 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, and 81 | Urinary N-telopeptide (of type 1 collagen) corrected for urine creatinine (uNTX/Cr) is a bone turnover marker used to measure the activity of denosumab. Percent change from Baseline in uNTX/Cr was measured over time. |
| Secondary | Percent Change From Baseline in Serum C-terminus Peptide (of Type 1 Collagen) | Baseline and Weeks 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, and 81 | Serum C-terminus peptide (of type 1 collagen; CTX1) is a bone turnover marker used to measure the activity of denosumab. Percent change from Baseline in CTX was measured over time. |
| Secondary | Serum Denosumab Trough Concentrations | Blood samples were collected on Days 1 (baseline), 8, 15 and Weeks 5 (Day 29), 9, 13, 25, and 49. | Serum concentrations of denosumab were measured by a validated conventional sandwich enzyme-linked immunosorbent assay (ELISA). |
| Secondary | Number of Participants With Adverse Events (AEs) | From the first dose of study drug until the data cut-off date of April 7 2008; a maximum of 18 months | An adverse event is defined as an undesirable medical occurrence (e.g., sign, symptom, or diagnosis) or worsening of a pre-existing medical condition. A serious adverse event (SAE) is defined by regulatory authorities as one that • is fatal • is life threatening (places the participant at immediate risk of death) • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard. The severity of adverse events was assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, version 3.0) based on the following general guideline: Grade 1: Mild AE Grade 2: Moderate AE Grade 3: Severe AE Grade 4: Life-threatening or disabling AE Grade 5: Death related to AE. AEs were assessed by the Investigator for relatedness to study drug. |
| Secondary | Number of Participants With Anti-Denosumab Antibodies | From enrollment until the data cut-off date of April 7 2008; a maximum time of 18 months. | Validated immunoassays were used to test for the presence of anti-denosumab antibodies throughout the study. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Giant Cell Tumor Response | From enrollment until 25 weeks | The efficacy analysis set included participants with a Baseline histology assessment and at least 1 postdose histology assessment from weeks 5-25; or a Baseline radiology assessment and at least 1 postdose radiology assessment from weeks 5-25. Evaluable participants had to be on study for at least 28 days after administration of the first dose. | percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Urinary N-telopeptide Corrected for Urine Creatinine | Baseline and Weeks 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, and 81 | Efficacy Analysis Set with available data at each time point (n). | percent change | MEDIAN |
| SECONDARY | Percent Change From Baseline in Serum C-terminus Peptide (of Type 1 Collagen) | Baseline and Weeks 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, and 81 | Efficacy Analysis Set with available data at each time point (n). | percent change | MEDIAN |
| SECONDARY | Serum Denosumab Trough Concentrations | Blood samples were collected on Days 1 (baseline), 8, 15 and Weeks 5 (Day 29), 9, 13, 25, and 49. | The pharmacokinetics analysis set included participants who received at least 1 dose of denosumab and for whom at least 1 serum denosumab trough concentration was available. 'n' indicates the number of participants with available data at each time point. | ng/mL | MEAN |
| SECONDARY | Number of Participants With Adverse Events (AEs) | From the first dose of study drug until the data cut-off date of April 7 2008; a maximum of 18 months | All participants who received at least 1 dose of denosumab. | participants | NUMBER |
| SECONDARY | Number of Participants With Anti-Denosumab Antibodies | From enrollment until the data cut-off date of April 7 2008; a maximum time of 18 months. | Participants who received at least 1 dose of denosumab and had at least 1 anti-denosumab antibody sample. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group57
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Giant Cell Tumor Response | Denosumab | 85.7 | 95% Confidence Interval 69.7 to 95.2 | percentage of participants | |
| Percent Change From Baseline in Urinary N-telopeptide Corrected for Urine Creatinine | Denosumab | Week 5 (n=30) | -70.9 | Inter-Quartile Range -79.6 to -15.0 | percent change |
| Percent Change From Baseline in Urinary N-telopeptide Corrected for Urine Creatinine | Denosumab | Week 9 (n=29) | -77.0 | Inter-Quartile Range -85.7 to -42.9 | percent change |
| Percent Change From Baseline in Urinary N-telopeptide Corrected for Urine Creatinine | Denosumab | Week 13 (n=27) | -60.0 | Inter-Quartile Range -84.2 to -36.0 | percent change |
| Percent Change From Baseline in Urinary N-telopeptide Corrected for Urine Creatinine | Denosumab | Week 17 (n=26) | -59.5 | Inter-Quartile Range -79.3 to -37.1 | percent change |
| Percent Change From Baseline in Urinary N-telopeptide Corrected for Urine Creatinine | Denosumab | Week 21 (n=24) | -64.5 | Inter-Quartile Range -80.1 to -19.1 | percent change |
| Percent Change From Baseline in Urinary N-telopeptide Corrected for Urine Creatinine | Denosumab | Week 25 (n=20) | -56.4 | Inter-Quartile Range -76.2 to 3.6 | percent change |
| Percent Change From Baseline in Urinary N-telopeptide Corrected for Urine Creatinine | Denosumab | Week 29 (n=21) | -52.8 | Inter-Quartile Range -78.4 to -22.8 | percent change |
| Percent Change From Baseline in Urinary N-telopeptide Corrected for Urine Creatinine | Denosumab | Week 33 (n=15) | -35.0 | Inter-Quartile Range -83.8 to 22.0 | percent change |
| Percent Change From Baseline in Urinary N-telopeptide Corrected for Urine Creatinine | Denosumab | Week 37 (n=13) | -71.1 | Inter-Quartile Range -83.4 to -41.4 | percent change |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Denosumab | 37 | |
| Overall Study | COMPLETED | Denosumab | 7 | |
| Overall Study | NOT COMPLETED | Denosumab | 30 |
Source ClinicalTrials.gov
Adverse events29
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 | Constipation | Gastrointestinal disorders | Denosumab 120 mg Q4W | 2 | 37 | |
| other | Diarrhoea | Gastrointestinal disorders | Denosumab 120 mg Q4W | 3 | 37 | |
| other | Nausea | Gastrointestinal disorders | Denosumab 120 mg Q4W | 2 | 37 | |
| other | Asthenia | General disorders | Denosumab 120 mg Q4W | 2 | 37 | |
| other | Fatigue | General disorders | Denosumab 120 mg Q4W | 3 | 37 | |
| other | Bronchitis | Infections and infestations | Denosumab 120 mg Q4W | 2 | 37 | |
| other | Influenza | Infections and infestations | Denosumab 120 mg Q4W | 2 | 37 | |
| other | Nasopharyngitis | Infections and infestations | Denosumab 120 mg Q4W | 3 | 37 | |
| other | Upper respiratory tract infection | Infections and infestations | Denosumab 120 mg Q4W | 2 | 37 | |
| other | Anorexia | Metabolism and nutrition disorders | Denosumab 120 mg Q4W | 2 | 37 |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Denosumab 120 mg Q4W | ||
| Total, other adverse events | Denosumab 120 mg Q4W | 25 | 37 |
| Total, serious adverse events | Denosumab 120 mg Q4W | 5 | 37 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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/NCT00396279
GET https://conductscience.org/api/trials/v1/NCT00396279/results?page=2