TriangleNCT00396279 · STUDY IN CONTEXT
Safety and Efficacy Study of Denosumab in Patients With Recurrent or Unresectable 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. 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
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.
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.
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.
Serum concentrations of denosumab were measured by a validated conventional sandwich enzyme-linked immunosorbent assay (ELISA).
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.
Validated immunoassays were used to test for the presence of anti-denosumab antibodies throughout the study.
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-of-bone
- nct id
- NCT00396279
- trial label
- Safety and Efficacy Study of Denosumab in Patients With Recurrent or Unresectable 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.
- 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
- 6
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-giant-cell-tumor-of-bone
- nct id
- NCT00396279
- outcome key
- om-0000
- source section id
- NCT00396279-om-0000
- source outcome index
- 0
- endpoint
- Percentage of Participants With Giant Cell Tumor Response
- endpoint definition
- 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.
- time origin
- From enrollment until 25 weeks
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- 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-of-bone
- nct id
- NCT00396279
- outcome key
- om-0001
- source section id
- NCT00396279-om-0001
- source outcome index
- 1
- endpoint
- Percent Change From Baseline in Urinary N-telopeptide Corrected for Urine Creatinine
- endpoint definition
- 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.
- time origin
- Baseline and Weeks 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, and 81
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Efficacy Analysis Set with available data at each time point (n).
- 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-of-bone
- nct id
- NCT00396279
- outcome key
- om-0002
- source section id
- NCT00396279-om-0002
- source outcome index
- 2
- endpoint
- Percent Change From Baseline in Serum C-terminus Peptide (of Type 1 Collagen)
- endpoint definition
- 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.
- time origin
- Baseline and Weeks 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, and 81
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Efficacy Analysis Set with available data at each time point (n).
- 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-of-bone
- nct id
- NCT00396279
- outcome key
- om-0003
- source section id
- NCT00396279-om-0003
- source outcome index
- 3
- endpoint
- Serum Denosumab Trough Concentrations
- endpoint definition
- Serum concentrations of denosumab were measured by a validated conventional sandwich enzyme-linked immunosorbent assay (ELISA).
- time origin
- Blood samples were collected on Days 1 (baseline), 8, 15 and Weeks 5 (Day 29), 9, 13, 25, and 49.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- 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-of-bone
- nct id
- NCT00396279
- outcome key
- om-0004
- source section id
- NCT00396279-om-0004
- source outcome index
- 4
- endpoint
- Number of Participants With Adverse Events (AEs)
- endpoint definition
- 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.
- time origin
- From the first dose of study drug until the data cut-off date of April 7 2008; a maximum of 18 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants who received at least 1 dose of denosumab.
- 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-of-bone
- nct id
- NCT00396279
- outcome key
- om-0005
- source section id
- NCT00396279-om-0005
- source outcome index
- 5
- endpoint
- Number of Participants With Anti-Denosumab Antibodies
- endpoint definition
- Validated immunoassays were used to test for the presence of anti-denosumab antibodies throughout the study.
- time origin
- From enrollment until the data cut-off date of April 7 2008; a maximum time of 18 months.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants who received at least 1 dose of denosumab and had at least 1 anti-denosumab antibody sample.
- 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-of-bone
- nct id
- NCT00396279
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Denosumab
- regimen
- Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
- analyzed count
- 35
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00396279-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-giant-cell-tumor-of-bone
- nct id
- NCT00396279
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Denosumab
- regimen
- Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
- analyzed count
- 35
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00396279-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-giant-cell-tumor-of-bone
- nct id
- NCT00396279
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Denosumab
- regimen
- Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
- analyzed count
- 35
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00396279-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-giant-cell-tumor-of-bone
- nct id
- NCT00396279
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Denosumab
- regimen
- Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
- analyzed count
- 37
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00396279-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-giant-cell-tumor-of-bone
- nct id
- NCT00396279
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Denosumab
- regimen
- Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
- analyzed count
- 37
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00396279-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-giant-cell-tumor-of-bone
- nct id
- NCT00396279
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Denosumab
- regimen
- Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
- analyzed count
- 31
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00396279-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-giant-cell-tumor-of-bone
- nct id
- NCT00396279
- harm key
- EG000
- source section id
- NCT00396279-ae
- event group key
- EG000
- event group label
- Denosumab 120 mg Q4W
- serious affected
- 5
- serious at risk
- 37
- other affected
- 25
- other at risk
- 37
- frequency threshold
- 5
- collection period
- up to 1 year 6 months
- event definition
- The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency.
- 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