A Phase 4 interventional study of Denosumab in Giant Cell Tumor of Bone, sponsored by Amgen. Completed at 14 sites in 8 countries. Per ClinicalTrials.gov, last updated 2024-05-20.
Sponsored by Amgen · Phase 4, Interventional, and Supportive care
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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.
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
23 studies on the registry are indexed under Giant Cell Tumor of Bone; 7 are open to participants now.
This study's enrollment of 85 is above the median of 43 across 16 interventional studies indexed under Giant Cell Tumor of Bone.
Browse Giant Cell Tumor of Bone studies →Amgen is the lead sponsor of 1,047 studies on the registry; 51 are open to participants now.
Of its 246 completed or terminated interventional studies of FDA-regulated products, 166 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Denosumab
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.
120 mg administered subcutaneously (SC) every 4 weeks (Q4W).
Also known as: AMG 162, Immunoglobulin G2 human monoclonal antibody to RANK ligand
Number of Participants Experiencing Adverse Events (AEs) of Interest (EOI)
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 frame: Up to approximately 5 years
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE)
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 frame: Up to approximately 5 years
Number of Participants With Disease Progression or Recurrence of GCTB
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 frame: Up to approximately 5 years
Number of Participants Receiving GCTB Interventions
GCTB interventions include: surgery, chemotherapy, embolization, interferon, and radiotherapy.
Time frame: Up to approximately 5 years
Participants with giant cell tumor of bone (GCTB) were enrolled across 8 countries (Australia, Italy, France, Poland, Spain, Sweden, the United Kingdom of Great Britain and Northern Ireland, and the United States) between November 2017 and July 2023.
| Milestone | Exposed to Investigational Product (IP) | Not Exposed to IP |
|---|---|---|
| Started | 51 | 34 |
| Received denosumab | 51 | 0 |
| Completed | 29 | 26 |
| Not completed | 22 | 8 |
| Withdrew: Death | 0 | 2 |
| Withdrew: Lost to follow-up | 4 | 2 |
| Withdrew: Decision by sponsor | 6 | 0 |
| Withdrew: Withdrawal by subject | 12 | 4 |
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.
| Count of Participants | Exposed to IP | Not Exposed to IP |
|---|---|---|
| Adjudicated positive ONJ | 3 | 0 |
| Malignancy, including malignancy in GCTB | 6 | 1 |
| Adjudicated positive AFF | 2 | 0 |
| Hypocalcemia | 3 | 0 |
| Hypocalcemia after treatment end | 0 | 0 |
| Pregnancy and lactation | 0 | 0 |
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).
| Count of Participants | Exposed to IP |
|---|---|
| All TEAEs | 47 |
| Serious TEAEs | 8 |
| Fatal TEAEs | 0 |
| TEAEs leading to IP discontinuation | 9 |
| CTCAE Grade 3, 4, or 5 | 16 |
| All TEAEs related to IP | 14 |
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.
| Count of Participants | Exposed to IP | Not Exposed to IP |
|---|---|---|
| Number of Participants With Disease Progression or Recurrence of GCTB | 5 | 3 |
GCTB interventions include: surgery, chemotherapy, embolization, interferon, and radiotherapy.
| Count of Participants | Exposed to IP | Not Exposed to IP |
|---|---|---|
| Surgery for GCTB | 1 | 3 |
| Chemotherapy or Other Therapeutic Agents | 0 | 2 |
| Embolization | 0 | 0 |
| Interferon | 0 | 0 |
| Radiotherapy | 0 | 0 |
Collected over Up to Approximately 5 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Exposed to IP | 0/51 (0%) | 8/51 (15.7%) | 37/51 (72.5%) |
| Not Exposed to IP | 2/34 (5.9%) | 0/34 (0%) | 0/34 (0%) |
| Event | Exposed to IP | Not Exposed to IP |
|---|---|---|
| Femur fractureInjury, poisoning and procedural complications | 2/51 | 0/34 |
| AnaemiaBlood and lymphatic system disorders | 1/51 | 0/34 |
| Anal fistulaGastrointestinal disorders | 1/51 | 0/34 |
| Gastrointestinal obstructionGastrointestinal disorders | 1/51 | 0/34 |
| Medical device site infectionInfections and infestations | 1/51 | 0/34 |
| SepsisInfections and infestations | 1/51 | 0/34 |
| Viral pericarditisInfections and infestations | 1/51 | 0/34 |
| Patella fractureInjury, poisoning and procedural complications | 1/51 | 0/34 |
| MyositisMusculoskeletal and connective tissue disorders | 1/51 | 0/34 |
| Osteonecrosis of jawMusculoskeletal and connective tissue disorders | 1/51 | 0/34 |
| Event | Exposed to IP | Not Exposed to IP |
|---|---|---|
| ToothacheGastrointestinal disorders | 8/51 | 0/34 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 8/51 | 0/34 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 8/51 | 0/34 |
| COVID-19Infections and infestations | 7/51 | 0/34 |
| Back painMusculoskeletal and connective tissue disorders | 7/51 | 0/34 |
| Osteonecrosis of jawMusculoskeletal and connective tissue disorders | 6/51 | 0/34 |
| CoughRespiratory, thoracic and mediastinal disorders | 5/51 | 0/34 |
| AnaemiaBlood and lymphatic system disorders | 4/51 | 0/34 |
| Foot fractureInjury, poisoning and procedural complications | 4/51 | 0/34 |
| MyalgiaMusculoskeletal and connective tissue disorders | 4/51 | 0/34 |
Full analysis set (FAS) included all enrolled participants (from study 20062004) who provided informed consent and had a non-missing enrolment date in this study.
| Age, Continuous(Years) | Exposed to IP | Not Exposed to IP | Total |
|---|---|---|---|
| Mean | 42.4 ± 12.8 | 46.7 ± 15.1 | 44.1 ± 13.9 |
| Sex: Female, Male(Participants) | Exposed to IP | Not Exposed to IP | Total |
|---|---|---|---|
| Female | 32 | 23 | 55 |
| Male | 19 | 11 | 30 |
| Ethnicity (NIH/OMB)(Participants) | Exposed to IP | Not Exposed to IP | Total |
|---|---|---|---|
| Hispanic or Latino | 13 | 10 | 23 |
| Not Hispanic or Latino | 38 | 24 | 62 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Exposed to IP | Not Exposed to IP | Total |
|---|---|---|---|
| White | 35 | 31 | 66 |
| Other | 10 | 0 | 10 |
| Black (or African American) | 4 | 3 | 7 |
| Asian | 2 | 0 | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
Data sharing details ↗ · www.amgen.com
Ran from Nov 2017 to primary completion in Jul 2023, 68 months.
Results were first posted in May 2024, 9 months after primary completion.
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Studies of the drug tested here: Denosumab