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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001758-32-SE

Enrollment

300

Registered

2017-08-02

Start date

2017-08-29

Completion date

Unknown

Last updated

2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Giant Cell Tumour of Bone

Interventions

Trade Name: XGEVA Product Name: Denosumab Product Code: AMG 162 Pharmaceutical Form: Solution for injection INN or Proposed INN: Denosumab CAS Number: 615258-40-7 Current Sponsor code: AMG 162 Other d

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Subject is currently enrolled in Study 20062004. - Subject or subject’s legally acceptable representative has provided informed consent/assent prior to initiation of any study-specific activities/procedures. Are the trial subjects under 18? yes Number of subjects for this age range: 15 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35

Exclusion criteria

Exclusion criteria: - Subject 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 subject 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate adverse events of interest in subjects with GCTB treated with denosumab in Study 20062004;Secondary Objective: Evaluate treatment-emergent adverse events for subjects who are receiving denosumab Evaluate serious adverse events for all subjects Summarize the rate of disease progression or recurrence of GCTB for all subjects Summarize the use of GCTB interventions for all subjects;Primary end point(s): Rate of adverse events of interest in subjects with GCTB treated with denosumab in Study 20062004;Timepoint(s) of evaluation of this end point: Throughout whole duration of study	—

Measure

Time frame

Main Objective: Evaluate adverse events of interest in subjects with GCTB treated with denosumab in Study 20062004;Secondary Objective: Evaluate treatment-emergent adverse events for subjects who are receiving denosumab Evaluate serious adverse events for all subjects Summarize the rate of disease progression or recurrence of GCTB for all subjects Summarize the use of GCTB interventions for all subjects;Primary end point(s): Rate of adverse events of interest in subjects with GCTB treated with denosumab in Study 20062004;Timepoint(s) of evaluation of this end point: Throughout whole duration of study

—

Secondary

Measure	Time frame
Secondary end point(s): Rate of treatment-emergent adverse events for subjects who are receiving denosumab Rate of serious adverse events for all subjects Rate of disease progression or recurrence of GCTB for all subjects Rate of GCTB interventions for all subjects;Timepoint(s) of evaluation of this end point: Throughout whole duration of study	—

Countries

Austria, France, Germany, Italy, Poland, Spain, Sweden, United Kingdom, United States

Contacts

Public ContactMedical Info - Clinical Trials

Amgen AB

medinfo.sweden@amgen.com+4686951100

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026