TriangleNCT03301857 · CITED IN SOURCE DOCUMENTS
Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE4
- Status at capture
- COMPLETED
- Registry last update
- 2024-05-20
Study 20140114 will continue to follow participants with GCTB who were treated in Study 20062004 and remained on the study at the completion of Study 20062004 for an additional 5 years on long-term safety follow up.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Number of Participants Experiencing Adverse Events (AEs) of Interest (EOI)
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE)
Number of Participants With Disease Progression or Recurrence of GCTB
Number of Participants Receiving GCTB Interventions
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Participant was previously enrolled in Study 20062004. * Participant or participant's legally acceptable representative has provided informed consent/assent prior to initiation of any study-specific activities/procedures. Exclusion Criteria: * Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participant and investigator's knowledge. * Females of childbearing potential on denosumab and not willing to continue to use 1 highly effective method of contraception during treatment and for 5 months after the end of treatment
- healthy Volunteers
- false
- sex
- ALL
- std Ages
- CHILD
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Participants who are still being treated with denosumab when 20062004 completes: 120 mg administered subcutaneously (SC) every 4 weeks (Q4W). For participants undergoing retreatment with denosumab: 120 mg administered SC on Days 1, 8, 15 and 28 then every 4 weeks subsequently.
- intervention Names
- Drug: Denosumab
- label
- Denosumab
- type
- EXPERIMENTAL
- description
- Participants who completed denosumab treatment and were in safety follow-up at the conclusion of 20062004 will have follow-up visits performed every 6 months via telephone or in-person clinic visit.
- label
- Safety Follow-up
- type
- NO_INTERVENTION
- interventions
- arm Group Labels
- Denosumab
- description
- 120 mg administered subcutaneously (SC) every 4 weeks (Q4W).
- name
- Denosumab
- other Names
- AMG 162, Immunoglobulin G2 human monoclonal antibody to RANK ligand
- type
- DRUG
Study design
- allocation
- NON_RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- SUPPORTIVE_CARE
Enrollment
- count
- 85
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- 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.
- measure
- Number of Participants Experiencing Adverse Events (AEs) of Interest (EOI)
- time Frame
- Up to approximately 5 years
- secondary Outcomes
- description
- 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).
- measure
- Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE)
- time Frame
- Up to approximately 5 years
- description
- 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.
- measure
- Number of Participants With Disease Progression or Recurrence of GCTB
- time Frame
- Up to approximately 5 years
- description
- GCTB interventions include: surgery, chemotherapy, embolization, interferon, and radiotherapy.
- measure
- Number of Participants Receiving GCTB Interventions
- time Frame
- Up to approximately 5 years
Full study description
- brief Summary
- Study 20140114 will continue to follow participants with GCTB who were treated in Study 20062004 and remained on the study at the completion of Study 20062004 for an additional 5 years on long-term safety follow up.
- detailed Description
- Study 20140114 will continue to follow participants with GCTB who were treated in Study 20062004 and remained on the study at the completion of Study 20062004 for an additional 5 years on long-term safety follow up. Collection of long-term safety information will include adverse events of interest and all treatment-emergent adverse events and serious adverse events
Source references
- see Also Links
- label
- AmgenTrials clinical trials website
Source notices and limitations
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Preserved source evidence · Not medical advice