TriangleNCT03301857 · STUDY IN CONTEXT
Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004
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
EOIs assessed in the study were signs and symptoms of osteonecrosis of the jaw (ONJ), malignancy (including malignancy in GCTB), atypical femoral fracture (AFF), hypocalcemia, hypercalcemia after treatment discontinuation, pregnancy and lactation (if occurring during treatment or within 5 months of the last dose of denosumab). Hypocalcemia includes events that occurred after 30 days following the last dose of IP and includes TEAEs only. Other EOIs encompass all events from signing the informed consent to the end of the study (approximately 5 years). ONJ and AFF events were adjudicated by independent reviewers.
An AE is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. An AE is considered as treatment-emergent if the AE occurs during the time period from the first dose of IP in this study through last dose of IP plus 30 days. TEAEs related to IP include only TEAEs for which the Investigator indicated there was a reasonable possibility they may have been caused by IP. AEs were graded (grade 3 \[severe or medically significant but not immediately life-threatening\], 4 \[life-threatening\], and 5 \[death related to the AE\]) using the Common Terminology Criteria for Adverse Events (CTCAE).
Disease progression or recurrence is defined as the best post-baseline response of progressive disease (PD) without any post-baseline complete response (CR) /partial response (PR) /stable disease (SD) or a post-baseline response of PD following a post-baseline CR/PR/SD. PD is defined as the response of progressive disease, locally recurrent disease or distant recurrence. CR is defined as no evidence of disease following surgical resection while on study 20062004. PR is defined as no new lesion or disease progression while enrolled in study 20062004. SD is defined as local disease progression/recurrence or distant metastatic disease while on study 20062004.
GCTB interventions include: surgery, chemotherapy, embolization, interferon, and radiotherapy.
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
- NCT03301857
- trial label
- Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004
- 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
- 4
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-giant-cell-tumor-of-bone
- nct id
- NCT03301857
- outcome key
- om-0000
- source section id
- NCT03301857-om-0000
- source outcome index
- 0
- endpoint
- Number of Participants Experiencing Adverse Events (AEs) of Interest (EOI)
- endpoint definition
- EOIs assessed in the study were signs and symptoms of osteonecrosis of the jaw (ONJ), malignancy (including malignancy in GCTB), atypical femoral fracture (AFF), hypocalcemia, hypercalcemia after treatment discontinuation, pregnancy and lactation (if occurring during treatment or within 5 months of the last dose of denosumab). Hypocalcemia includes events that occurred after 30 days following the last dose of IP and includes TEAEs only. Other EOIs encompass all events from signing the informed consent to the end of the study (approximately 5 years). ONJ and AFF events were adjudicated by independent reviewers.
- time origin
- Up to approximately 5 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- FAS included all enrolled participants (from study 20062004) who provided informed consent and had a non-missing enrolment date in this 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-of-bone
- nct id
- NCT03301857
- outcome key
- om-0001
- source section id
- NCT03301857-om-0001
- source outcome index
- 1
- endpoint
- Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE)
- endpoint definition
- An AE is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. An AE is considered as treatment-emergent if the AE occurs during the time period from the first dose of IP in this study through last dose of IP plus 30 days. TEAEs related to IP include only TEAEs for which the Investigator indicated there was a reasonable possibility they may have been caused by IP. AEs were graded (grade 3 \[severe or medically significant but not immediately life-threatening\], 4 \[life-threatening\], and 5 \[death related to the AE\]) using the Common Terminology Criteria for Adverse Events (CTCAE).
- time origin
- Up to approximately 5 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- FAS included all enrolled participants (from study 20062004) who provided informed consent and had a non-missing enrolment date in this 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-of-bone
- nct id
- NCT03301857
- outcome key
- om-0002
- source section id
- NCT03301857-om-0002
- source outcome index
- 2
- endpoint
- Number of Participants With Disease Progression or Recurrence of GCTB
- endpoint definition
- Disease progression or recurrence is defined as the best post-baseline response of progressive disease (PD) without any post-baseline complete response (CR) /partial response (PR) /stable disease (SD) or a post-baseline response of PD following a post-baseline CR/PR/SD. PD is defined as the response of progressive disease, locally recurrent disease or distant recurrence. CR is defined as no evidence of disease following surgical resection while on study 20062004. PR is defined as no new lesion or disease progression while enrolled in study 20062004. SD is defined as local disease progression/recurrence or distant metastatic disease while on study 20062004.
- time origin
- Up to approximately 5 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- FAS included all enrolled participants (from study 20062004) who provided informed consent and had a non-missing enrolment date in this study. The number of participants analyzed is inclusive of participants with available data.
- 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
- NCT03301857
- outcome key
- om-0003
- source section id
- NCT03301857-om-0003
- source outcome index
- 3
- endpoint
- Number of Participants Receiving GCTB Interventions
- endpoint definition
- GCTB interventions include: surgery, chemotherapy, embolization, interferon, and radiotherapy.
- time origin
- Up to approximately 5 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- FAS included all enrolled participants (from study 20062004) who provided informed consent and had a non-missing enrolment date in this study.
- 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
- NCT03301857
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Exposed to IP
- regimen
- Participants who received denosumab at the conclusion of study 20062004 continued in this study (study 20140114), and received denosumab at the current dose (120 mg Q4W SC) and schedule at the investigator's discretion.
- analyzed count
- 51
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03301857-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-giant-cell-tumor-of-bone
- nct id
- NCT03301857
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Not Exposed to IP
- regimen
- Participants who completed denosumab treatment in study 20062004 and were in the safety follow up at the conclusion of study 20062004 continued in long term safety follow up in this study (study 20140114), and did not receive denosumab.
- analyzed count
- 34
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03301857-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-giant-cell-tumor-of-bone
- nct id
- NCT03301857
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Exposed to IP
- regimen
- Participants who received denosumab at the conclusion of Study 20062004 continued in this study (study 20140114), and received denosumab at the current dose (120 mg Q4W SC) and schedule at the investigator's discretion.
- analyzed count
- 51
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03301857-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-giant-cell-tumor-of-bone
- nct id
- NCT03301857
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Exposed to IP
- regimen
- Participants who received denosumab at the conclusion of Study 20062004 continued in this study (study 20140114), and received denosumab at the current dose (120 mg Q4W SC) and schedule at the investigator's discretion.
- analyzed count
- 50
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03301857-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-giant-cell-tumor-of-bone
- nct id
- NCT03301857
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Not Exposed to IP
- regimen
- Participants who completed denosumab treatment in study 20062004 and were in the safety follow up at the conclusion of study 20062004 continued in long term safety follow up in this study (study 20140114), and did not receive denosumab.
- analyzed count
- 33
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03301857-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-giant-cell-tumor-of-bone
- nct id
- NCT03301857
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Exposed to IP
- regimen
- Participants who received denosumab at the conclusion of Study 20062004 continued in this study (study 20140114), and received denosumab at the current dose (120 mg Q4W SC) and schedule at the investigator's discretion.
- analyzed count
- 51
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03301857-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-giant-cell-tumor-of-bone
- nct id
- NCT03301857
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Not Exposed to IP
- regimen
- Participants who completed denosumab treatment in study 20062004 and were in the safety follow up at the conclusion of study 20062004 continued in long term safety follow up in this study (study 20140114), and did not receive denosumab.
- analyzed count
- 34
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03301857-om-0003#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-giant-cell-tumor-of-bone
- nct id
- NCT03301857
- harm key
- EG000
- source section id
- NCT03301857-ae
- event group key
- EG000
- event group label
- Exposed to IP
- serious affected
- 8
- serious at risk
- 51
- other affected
- 37
- other at risk
- 51
- frequency threshold
- 5
- collection period
- Up to Approximately 5 years
- event definition
- FAS included all enrolled participants (from study 20062004) who provided informed consent and had a non-missing enrolment date in this study.
- undenominated note
- Source null
- 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
- NCT03301857
- harm key
- EG001
- source section id
- NCT03301857-ae
- event group key
- EG001
- event group label
- Not Exposed to IP
- serious affected
- 0
- serious at risk
- 34
- other affected
- 0
- other at risk
- 34
- frequency threshold
- 5
- collection period
- Up to Approximately 5 years
- event definition
- FAS included all enrolled participants (from study 20062004) who provided informed consent and had a non-missing enrolment date in this study.
- 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