Open Label Extension to SRE Studies in United Kingdom and Czech Republic Only

Conditions: Bone metastases in subjects with advanced cancer or multiple myeloma
MedDRA version: 14.0Level: LLTClassification code 10005993Term: Bone metastasesSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2009-009374-27-CZ

Lead Sponsor: Amgen Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 35

Inclusion Criteria

Subjects currently enrolled in study 20050103, 20050136, or 20050244

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 19

Exclusion Criteria

Developed sensitivity to mammalian cell derived drug products during the 20050103, 20050136, or 20050244 study

Currently receiving any unapproved investigational product other than denosumab

Subject is pregnant or breast feeding, or planning to become pregnant within 7 months after the end of treatment

Subject (male or female) is not willing to use 2 highly effective contraception during treatment and for 7 months (women) or 10 months (men) after the end of treatment

Male subject with a pregnant partner who is not willing to use a condom during treatment and for additional 10 months after the end of treatment

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 denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received either zoledronic acid (Zometa®) or denosumab.;Secondary Objective: Not applicable;Primary end point(s): • Subject incidence of treatment-emergent adverse events<br>• Changes in laboratory values<br>• Incidence of anti-denosumab antibody (binding and neutralizing) formation<br>• Brief Pain Inventory – Short Form worst” pain score<br>;Timepoint(s) of evaluation of this end point: 2 Years

Secondary Outcome Measures