Clinical trial NCT03301857: Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004
Official title: Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Giant Cell Tumor of Bone
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2017-10-04
Enrollment: 85
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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

Primary outcomes:
measure: Number of Participants Experiencing Adverse Events (AEs) of Interest (EOI)
timeFrame: Up to approximately 5 years
Secondary outcomes:
measure: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE)
timeFrame: Up to approximately 5 years
measure: Number of Participants With Disease Progression or Recurrence of GCTB
timeFrame: Up to approximately 5 years
measure: Number of Participants Receiving GCTB Interventions
timeFrame: Up to approximately 5 years
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Sarcoma Oncology Research Center LLC
state: California
city: Washington
country: United States
facility: Washington Cancer Institute at MedStar Washington Hospital
state: District of Columbia
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center Fairview
state: Minnesota
city: New York
country: United States
facility: Mount Sinai Beth Israel Downtown
state: New York
city: Philadelphia
country: United States
facility: Abramson Cancer Center at Pennsylvania Hospital
state: Pennsylvania
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Lyon CEDEX 08
country: France
facility: Centre Leon Berard
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Bologna
country: Italy
facility: Istituti Ortopedici Rizzoli
city: Warszawa
country: Poland
facility: Instytut Matki i Dziecka
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie â€" Panstwowy Instytut Badawczy
city: Palma de Mallorca
country: Spain
facility: Hospital Universitari Son Espases
state: Baleares
city: Lund
country: Sweden
facility: Skane Universitetssjukhus
city: Birmingham
country: United Kingdom
facility: Royal Orthopaedic Hospital
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: