Trial · NCT00680992
Study of Denosumab in Subjects With Giant Cell Tumor of Bone
NCT00680992, Phase 2, Completed, Amgen; results first posted 2018-12-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Denosumab in Subjects With Giant Cell Tumor of Bone. Trials, record NCT00680992. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00680992
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Denosumab in Subjects With Giant Cell Tumor of Bone
- NCT number
- NCT00680992
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 535 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Cancer, Giant Cell Tumors, Giant Cell Tumor of Bone, Benign Giant Cell Tumors
- Interventions
- Denosumab
- First posted
- 2008-05-20
- Last updated
- 2022-09-22
- Results first posted
- 2018-12-10
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From first dose of study drug up to last study visit for treatment-emergent period (a maximum of approximately 111 months). | AE defined as any untoward medical occurrence in a clinical trial participant. Serious AE defined as AE that is fatal, life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or other significant medical hazard. Severity of AEs assessed according to Common Terminology Criteria for Adverse Events (CTCAE, v3.0) based on the general guideline: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening or disabling; Grade 5: Death related to AE. Investigator assessed AEs for relatedness to study drug. Results are presented for treatment-emergent events (TEAEs) and included all AEs occurring from first dose in initial treatment phase to end of initial treatment phase (or for participants entering retreatment, from first dose in initial treatment phase until end of retreatment phase). |
| Primary | Number of Participants Who Experienced the Maximum Toxicity Grade (CTCAE Grade ≥ 3) in the Indicated Clinical Chemistry Parameters | Baseline (day 1) up to last study visit for initial treatment phase (median duration approximately 30 months up to a maximum of approximately 109 months). | Serum samples for clinical chemistry were collected on study day 1 (baseline), day 15, week 5 and each study visit Q4W thereafter until last study visit for the on-study period (ie, until end of initial treatment phase). The parameters included albumin, calcium (albumin-adjusted), creatinine, magnesium and phosphate. Results are presented for number of participants who experienced the maximum toxicity grade for each of these clinical parameters. The maximum toxicity grade experienced by each participant was based on CTCAE, v3.0, and are summarized for Grade 3 and 4. Increases and decreases in relationship to the normal parameter ranges are indicated as 'Above' and 'Below' respectively. |
| Secondary | Time to Disease Progression or Recurrence During the On-Study Period for Cohort 1, Presented as Kaplan-Meier Estimates of Probability | From first dose of study drug up to the end of the initial treatment phase (median duration approximately 30 months up to a maximum of approximately 109 months). | Time to disease progression or recurrence during the on-study period was defined as the time interval (in days) from the date of first dose of study drug to the date of earliest Progressive Disease (PD) during the initial treatment phase. PD was defined as the response of progressive disease, locally recurrent disease or relapse as captured in the Disease Status page of the Case Report Form. If a participant had not had PD by the end of the initial treatment phase date, time to disease progression or recurrence were censored at her/his end of initial treatment phase date. Since median time to disease progression or recurrence for participants in cohort 1 was not reached, Kaplan-Meier estimates for the probability (expressed as a percentage) of participants in cohort 1 to have disease progression or recurrence at months 6, 12, 24, 36 and 60 are presented. |
| Secondary | Percentage of Participants Without Any On-Study Surgery at Month 6 for Cohort 2 | At month 6. | The percentage of participants without any surgery at month 6 was equivalent to the number of participants without any surgery by month 6 divided by the number of cohort 2 participants who had an opportunity to complete 6 months of treatment, expressed as a percentage. |
| Secondary | Mean Serum Denosumab Trough Concentrations | Blood samples were collected at baseline (day 1), days 8 and 15 and weeks 5, 9, 13 and 25. | Blood samples for determination of serum denosumab concentration levels were obtained from participants included in the pharmacokinetic (PK) substudy at baseline (prior to administration of study drug on day 1) and at scheduled time points during the study up to week 25. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From first dose of study drug up to last study visit for treatment-emergent period (a maximum of approximately 111 months). | The safety analysis set included all enrolled participants who received at least one dose of denosumab on the study. | Participants | NUMBER |
| PRIMARY | Number of Participants Who Experienced the Maximum Toxicity Grade (CTCAE Grade ≥ 3) in the Indicated Clinical Chemistry Parameters | Baseline (day 1) up to last study visit for initial treatment phase (median duration approximately 30 months up to a maximum of approximately 109 months). | The safety analysis set included all enrolled participants who received at least one dose of denosumab on the study. | Participants | NUMBER |
| SECONDARY | Time to Disease Progression or Recurrence During the On-Study Period for Cohort 1, Presented as Kaplan-Meier Estimates of Probability | From first dose of study drug up to the end of the initial treatment phase (median duration approximately 30 months up to a maximum of approximately 109 months). | The efficacy analysis set included all enrolled participants who were eligible for the study, and who received at least one dose of denosumab on the study. Analysis was performed on cohort 1 only. | Percent probability | NUMBER |
| SECONDARY | Percentage of Participants Without Any On-Study Surgery at Month 6 for Cohort 2 | At month 6. | The efficacy analysis set included all enrolled participants who were eligible for the study, and who received at least one dose of denosumab on the study. Analysis was performed on cohort 2 only for those who had the opportunity to be on-study for at least 6 months. | Percentage of participants | NUMBER |
| SECONDARY | Mean Serum Denosumab Trough Concentrations | Blood samples were collected at baseline (day 1), days 8 and 15 and weeks 5, 9, 13 and 25. | The PK analysis set included all participants who received at least 1 dose of denosumab with baseline PK measurement and at least 1 post-baseline PK measurement. Only participants with available data at each time point were included in the analysis. | nanograms / milliliter | MEAN |
Source ClinicalTrials.gov
Results by group70
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Cohort 1 (Denosumab 120 mg Q4W) | Any TEAE | 260 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Cohort 2 (Denosumab 120 mg Q4W) | Any TEAE | 231 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Cohort 3 (Denosumab 120 mg Q4W) | Any TEAE | 12 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Cohort 1 (Denosumab 120 mg Q4W) | Serious TEAE | 98 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Cohort 2 (Denosumab 120 mg Q4W) | Serious TEAE | 39 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Cohort 3 (Denosumab 120 mg Q4W) | Serious TEAE | 5 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Cohort 1 (Denosumab 120 mg Q4W) | Fatal TEAE | 8 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Cohort 2 (Denosumab 120 mg Q4W) | Fatal TEAE | 3 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Cohort 3 (Denosumab 120 mg Q4W) | Fatal TEAE | 0 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Cohort 1 (Denosumab 120 mg Q4W) | TEAE leading to treatment phase discontinuation | 27 | Participants |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 (Denosumab 120 mg Q4W) | 268 | |
| Overall Study | STARTED | Cohort 2 (Denosumab 120 mg Q4W) | 252 | |
| Overall Study | STARTED | Cohort 3 (Denosumab 120 mg Q4W) | 12 | |
| Overall Study | Safety Analysis Set | Cohort 1 (Denosumab 120 mg Q4W) | 265 | |
| Overall Study | Safety Analysis Set | Cohort 2 (Denosumab 120 mg Q4W) | 249 | |
| Overall Study | Safety Analysis Set | Cohort 3 (Denosumab 120 mg Q4W) | 12 | |
| Overall Study | Efficacy Analysis Set | Cohort 1 (Denosumab 120 mg Q4W) | 260 | |
| Overall Study | Efficacy Analysis Set | Cohort 2 (Denosumab 120 mg Q4W) | 242 | |
| Overall Study | Efficacy Analysis Set | Cohort 3 (Denosumab 120 mg Q4W) | 11 | |
| Overall Study | COMPLETED | Cohort 1 (Denosumab 120 mg Q4W) | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events239
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 | Anaemia | Blood and lymphatic system disorders | Denosumab 120 mg Q4W (All Cohorts) | 30 | 526 | |
| other | Abdominal pain | Gastrointestinal disorders | Denosumab 120 mg Q4W (All Cohorts) | 49 | 526 | |
| other | Constipation | Gastrointestinal disorders | Denosumab 120 mg Q4W (All Cohorts) | 60 | 526 | |
| other | Dental caries | Gastrointestinal disorders | Denosumab 120 mg Q4W (All Cohorts) | 32 | 526 | |
| other | Diarrhoea | Gastrointestinal disorders | Denosumab 120 mg Q4W (All Cohorts) | 60 | 526 | |
| other | Nausea | Gastrointestinal disorders | Denosumab 120 mg Q4W (All Cohorts) | 122 | 526 | |
| other | Toothache | Gastrointestinal disorders | Denosumab 120 mg Q4W (All Cohorts) | 68 | 526 | |
| other | Vomiting | Gastrointestinal disorders | Denosumab 120 mg Q4W (All Cohorts) | 66 | 526 | |
| other | Asthenia | General disorders | Denosumab 120 mg Q4W (All Cohorts) | 48 | 526 | |
| other | Fatigue | General disorders | Denosumab 120 mg Q4W (All Cohorts) | 142 | 526 |
1 to 10 of 239Source ClinicalTrials.gov
See all 239 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 (All Cohorts) | 26 | 526 |
| Total, other adverse events | Denosumab 120 mg Q4W (All Cohorts) | 480 | 526 |
| Total, serious adverse events | Denosumab 120 mg Q4W (All Cohorts) | 176 | 526 |
Source ClinicalTrials.gov
Papers9
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/NCT00680992
GET https://conductscience.org/api/trials/v1/NCT00680992/results?page=2