Neoplasms

Musculoskeletal Diseases

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Bone Neoplasms

Giant Cell Tumors

Giant Cell Tumor of Bone

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Bone Diseases

Neoplasms, Bone Tissue

All Drugs and Chemicals

Bone Density Conservation Agents

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Immunoglobulin G

Denosumab

Immunoglobulins, Intravenous

Immunologic Factors

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.

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).

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

Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

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.

Amgen

FAS included all enrolled participants (from study 20062004) who provided informed consent and had a non-missing enrolment date in this study.

Exposed to IP

Not Exposed to IP

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.

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.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

White

Other

Black (or African American)

Asian

Race/Ethnicity, Customized

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.

Study Director

Adjudicated positive ONJ

Malignancy, including malignancy in GCTB

Adjudicated positive AFF

Hypocalcemia

Hypocalcemia after treatment end

Pregnancy and lactation

Number of Participants Experiencing Adverse Events (AEs) of Interest (EOI)

All TEAEs

Serious TEAEs

Fatal TEAEs

TEAEs leading to IP discontinuation

CTCAE Grade 3, 4, or 5

All TEAEs related to IP

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.

Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE)

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.

Number of Participants With Disease Progression or Recurrence of GCTB

Surgery for GCTB

Chemotherapy or Other Therapeutic Agents

Embolization

Interferon

Radiotherapy

Number of Participants Receiving GCTB Interventions

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 every 4 weeks \[Q4W\] subcutaneous injection \[SC\]) and schedule at the investigator's discretion.

Spots Global Cancer Trial Database for Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial