TriangleNCT00680992 · STUDY IN CONTEXT
Study of Denosumab in Subjects With Giant Cell Tumor of Bone
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
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).
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.
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.
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.
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.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-giant-cell-tumor
- nct id
- NCT00680992
- trial label
- Study of Denosumab in Subjects With Giant Cell Tumor of Bone
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 5
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-giant-cell-tumor
- nct id
- NCT00680992
- outcome key
- om-0000
- source section id
- NCT00680992-om-0000
- source outcome index
- 0
- endpoint
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
- endpoint definition
- 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).
- time origin
- From first dose of study drug up to last study visit for treatment-emergent period (a maximum of approximately 111 months).
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The safety analysis set included all enrolled participants who received at least one dose of denosumab on the study.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-giant-cell-tumor
- nct id
- NCT00680992
- outcome key
- om-0001
- source section id
- NCT00680992-om-0001
- source outcome index
- 1
- endpoint
- Number of Participants Who Experienced the Maximum Toxicity Grade (CTCAE Grade ≥ 3) in the Indicated Clinical Chemistry Parameters
- endpoint definition
- 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.
- time origin
- 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).
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The safety analysis set included all enrolled participants who received at least one dose of denosumab on the study.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-giant-cell-tumor
- nct id
- NCT00680992
- outcome key
- om-0002
- source section id
- NCT00680992-om-0002
- source outcome index
- 2
- endpoint
- Time to Disease Progression or Recurrence During the On-Study Period for Cohort 1, Presented as Kaplan-Meier Estimates of Probability
- endpoint definition
- 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.
- time origin
- 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).
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-giant-cell-tumor
- nct id
- NCT00680992
- outcome key
- om-0003
- source section id
- NCT00680992-om-0003
- source outcome index
- 3
- endpoint
- Percentage of Participants Without Any On-Study Surgery at Month 6 for Cohort 2
- endpoint definition
- 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.
- time origin
- At month 6.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-giant-cell-tumor
- nct id
- NCT00680992
- outcome key
- om-0004
- source section id
- NCT00680992-om-0004
- source outcome index
- 4
- endpoint
- Mean Serum Denosumab Trough Concentrations
- endpoint definition
- 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.
- time origin
- Blood samples were collected at baseline (day 1), days 8 and 15 and weeks 5, 9, 13 and 25.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-giant-cell-tumor
- nct id
- NCT00680992
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Cohort 1 (Denosumab 120 mg Q4W)
- regimen
- Participants with surgically unsalvageable disease (eg, sacral, spinal GCTB, or multiple lesions including pulmonary metastases) were enrolled into cohort 1 and received denosumab 120 mg SC once Q4W, starting on study day 1, plus loading doses of 120 mg SC on days 8 and 15 in the first month of treatment.
- analyzed count
- 265
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00680992-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-giant-cell-tumor
- nct id
- NCT00680992
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Cohort 2 (Denosumab 120 mg Q4W)
- regimen
- Participants with surgically salvageable disease whose planned initial on-study surgery was associated with severe morbidity (eg, joint resection, limb amputation, or hemipelvectomy) were enrolled into cohort 2 and received denosumab 120 mg SC Q4W, starting on study day 1, plus loading doses of 120 mg SC on days 8 and 15 in the first month of treatment.
- analyzed count
- 249
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00680992-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-giant-cell-tumor
- nct id
- NCT00680992
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Cohort 3 (Denosumab 120 mg Q4W)
- regimen
- Participants who participated in study 20040215 and were eligible to enroll in the current study (20062004) for continuation of treatment were enrolled into cohort 3 and received denosumab 120 mg SC Q4W, starting on study day 1. Participants in cohort 3 did not receive loading doses of denosumab on days 8 and 15 in the first month of treatment.
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00680992-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-giant-cell-tumor
- nct id
- NCT00680992
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Cohort 1 (Denosumab 120 mg Q4W)
- regimen
- Participants with surgically unsalvageable disease (eg, sacral, spinal GCTB, or multiple lesions including pulmonary metastases) were enrolled into cohort 1 and received denosumab 120 mg SC once Q4W, starting on study day 1, plus loading doses of 120 mg SC on days 8 and 15 in the first month of treatment.
- analyzed count
- 265
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00680992-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-giant-cell-tumor
- nct id
- NCT00680992
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Cohort 2 (Denosumab 120 mg Q4W)
- regimen
- Participants with surgically salvageable disease whose planned initial on-study surgery was associated with severe morbidity (eg, joint resection, limb amputation, or hemipelvectomy) were enrolled into cohort 2 and received denosumab 120 mg SC Q4W, starting on study day 1, plus loading doses of 120 mg SC on days 8 and 15 in the first month of treatment.
- analyzed count
- 249
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00680992-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-giant-cell-tumor
- nct id
- NCT00680992
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Cohort 3 (Denosumab 120 mg Q4W)
- regimen
- Participants who participated in study 20040215 and were eligible to enroll in the current study (20062004) for continuation of treatment were enrolled into cohort 3 and received denosumab 120 mg SC Q4W, starting on study day 1. Participants in cohort 3 did not receive loading doses of denosumab on days 8 and 15 in the first month of treatment.
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00680992-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-giant-cell-tumor
- nct id
- NCT00680992
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Cohort 1 (Denosumab 120 mg Q4W)
- regimen
- Participants with surgically unsalvageable disease (eg, sacral, spinal GCTB, or multiple lesions including pulmonary metastases) were enrolled into cohort 1 and received denosumab 120 mg SC once Q4W, starting on study day 1, plus loading doses of 120 mg SC on days 8 and 15 in the first month of treatment.
- analyzed count
- 260
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00680992-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-giant-cell-tumor
- nct id
- NCT00680992
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Cohort 2 (Denosumab 120 mg Q4W)
- regimen
- Participants with surgically salvageable disease whose planned initial on-study surgery was associated with severe morbidity (eg, joint resection, limb amputation, or hemipelvectomy) were enrolled into cohort 2 and received denosumab 120 mg SC Q4W, starting on study day 1, plus loading doses of 120 mg SC on days 8 and 15 in the first month of treatment.
- analyzed count
- 238
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00680992-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-giant-cell-tumor
- nct id
- NCT00680992
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Adolescent PK Subset (Denosumab 120 mg Q4W)
- regimen
- Adolescent participants enrolled in the PK substudy who received at least 1 dose of denosumab with baseline PK measurement and at least 1 post-baseline PK measurement were included in the adolescent PK analysis set. Participants received denosumab 120 mg SC Q4W, starting on study day 1, with loading doses of 120 mg SC on days 8 and 15 in the first month of treatment for those enrolled in cohorts 1 or 2.
- analyzed count
- 10
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00680992-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-giant-cell-tumor
- nct id
- NCT00680992
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Adult PK Subset (Denosumab 120 mg Q4W)
- regimen
- Adult participants enrolled in the PK substudy who received at least 1 dose of denosumab with baseline PK measurement and at least 1 post-baseline PK measurement were included in the adult PK analysis set. Participants received denosumab 120 mg SC Q4W, starting on study day 1, with loading doses of 120 mg SC on days 8 and 15 in the first month of treatment for those enrolled in cohorts 1 or 2.
- analyzed count
- 15
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00680992-om-0004#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-giant-cell-tumor
- nct id
- NCT00680992
- harm key
- EG000
- source section id
- NCT00680992-ae
- event group key
- EG000
- event group label
- Denosumab 120 mg Q4W (All Cohorts)
- serious affected
- 176
- serious at risk
- 526
- other affected
- 480
- other at risk
- 526
- frequency threshold
- 5
- collection period
- From first dose of study drug until last study visit; a maximum of approximately 113 months. The planned study duration for each participant was at least 60 months (following protocol amendment 7).
- event definition
- Data are presented for the entire study duration and include AEs occurring during the treatment-emergent period (comprising both the initial treatment phase and retreatment phase) and AEs occurring after the treatment-emergent period (ie, during the safety follow-up phase).
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice