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

Giant Cell Tumor of Bone Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03301857
• Other study ID #: 20140114
• Secondary ID: 2017-001758-32
• Status: Completed
• Phase: Phase 4
• Start date: November 13, 2017
• Est. completion date: July 27, 2023

Study information

• Verified date: May 2024
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: July 27, 2023
• Est. primary completion date: July 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Neoplasms
• Giant Cell Tumor of Bone
• Giant Cell Tumors

Intervention

Drug:
• Denosumab
120 mg administered subcutaneously (SC) every 4 weeks (Q4W).

Locations

Country	Name	City	State
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
France	Centre Leon Berard	Lyon CEDEX 08
France	Institut Gustave Roussy	Villejuif
Italy	Istituti Ortopedici Rizzoli	Bologna
Poland	Instytut Matki i Dziecka	Warszawa
Poland	Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie â€" Panstwowy Instytut Badawczy	Warszawa
Spain	Hospital Universitari Son Espases	Palma de Mallorca	Baleares
Sweden	Skane Universitetssjukhus	Lund
United Kingdom	Royal Orthopaedic Hospital	Birmingham
United States	University of Minnesota Medical Center Fairview	Minneapolis	Minnesota
United States	Mount Sinai Beth Israel Downtown	New York	New York
United States	Abramson Cancer Center at Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	Sarcoma Oncology Research Center LLC	Santa Monica	California
United States	Washington Cancer Institute at MedStar Washington Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Australia,  France,  Italy,  Poland,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to approximately 5 years
Secondary	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).	Up to approximately 5 years
Secondary	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.	Up to approximately 5 years
Secondary	Number of Participants Receiving GCTB Interventions	GCTB interventions include: surgery, chemotherapy, embolization, interferon, and radiotherapy.	Up to approximately 5 years

External Links

•   AmgenTrials clinical trials website