An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab for Prolonging Bone Metastasis-Free Survival in Men with Hormone-Refractory Prostate Cancer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-021846-23-GB

Enrollment

Registered

2010-08-10

Start date

2010-11-24

Completion date

Unknown

Last updated

2019-12-10

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

Conditions

Castrate-resistant prostate cancer MedDRA version: 14.1 Level: LLT Classification code 10062904 Term: Hormone-refractory prostate cancer System Organ Class: 100000004864

Interventions

Trade Name: Prolia Product Name: Denosumab Product Code: AMG 162 Pharmaceutical Form: Solution for injection INN or Proposed INN: Denosu

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: • Subjects currently undergoing every 4 weeks scheduled assessments in the phase 3 study 20050147 • Subjects must sign the informed consent before any study specific procedures are performed Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 18

Exclusion criteria

Exclusion criteria: • Developed sensitivity to mammalian cell derived drug products during the 20050147 study • Currently receiving any unapproved investigational product other than denosumab • Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures

Design outcomes

Primary

Measure	Time frame
Main Objective: To describe the safety and tolerability of denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received denosumab;Secondary Objective: To describe the safety and tolerability of denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received placebo; Primary end point(s): • Subject incidence of treatment-emergent adverse events • Changes in laboratory values • Subject incidence of anti-denosumab neutralizing antibody formation ;Timepoint(s) of evaluation of this end point: 3 years	—

Measure

Time frame

Main Objective: To describe the safety and tolerability of denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received denosumab;Secondary Objective: To describe the safety and tolerability of denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received placebo; Primary end point(s): • Subject incidence of treatment-emergent adverse events • Changes in laboratory values • Subject incidence of anti-denosumab neutralizing antibody formation ;Timepoint(s) of evaluation of this end point: 3 years

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable ;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Czech Republic, United Kingdom

Contacts

Public ContactIHQ Medical Info – Clinical Trials

Amgen (EUROPE) GmbH

MedinfoInternational@amgen.comNANANANA

Outcome results

None listed

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