An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab (AMG 162) in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-Metastatic Prostate Cancer
- Conditions
- Androgen-dependent non-metastatic prostate cancer and therapy-induced bone lossMedDRA version: 14.0Level: PTClassification code 10065687Term: Bone lossSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersMedDRA version: 14.0Level: LLTClassification code 10036910Term: Prostate cancer NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2008-006154-17-FI
- Lead Sponsor
- Amgen Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 384
Subjects must be currently participating in the 20040138 study
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) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 368
Subjects with any prior diagnosis of bone metastasis
Known hypocalcemia
Developed sensitivity to mammalian cell derived drug products during the 20040138 study
Currently receiving any investigational product other than denosumab or having received any investigational product during the 20040138 study
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To describe the safety and tolerability of up to 5 years (ie, 3 years under study 20040138 and 2 years under study 20080537) 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 up to 2 years denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received placebo.;Primary end point(s): The primary endpoints are safety endpoints, including adverse event incidence, serious adverse event incidence, changes in safety laboratory analytes (ie, serum chemistry) and subject incidence of anti-denosumab antibody formation in subjects previously treated with denosumab who receive up to 5 years of denosumab administration.;Timepoint(s) of evaluation of this end point: 2 years
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The secondary endpoints are safety endpoints, including adverse event incidence, serious adverse event incidence, changes in safety laboratory analytes (ie, serum chemistry) and subject incidence of anti-denosumab antibody formation in subjects previously treated with placebo who receive up to 2 years of denosumab administration.;Timepoint(s) of evaluation of this end point: 2 years