NCT00950911 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2014-02-11

The purpose of this study is 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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants Survived

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Subjects currently enrolled in study 20050103, 20050136, or 20050244 * Subjects must sign the informed consent before any study specific procedures are performed 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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

intervention Names
Drug: amg 162
label
1
type
EXPERIMENTAL

interventions

arm Group Labels
1
description
120 mg SC injection of denosumab Q4W until the subject has access to commercially available product or for up to 2 years, which ever comes first.
name
amg 162
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

SUPPORTIVE_CARE

Enrollment

count: 35
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

measure
Number of Participants Survived
time Frame
2 years

Full study description

brief Summary: The purpose of this study is 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.

Source references