An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab (AMG162) in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer
Phase 3
Completed
- Conditions
- botziektenbone loss
- Registration Number
- NL-OMON36983
- Lead Sponsor
- Amgen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
Inclusion Criteria
Subjects must be currently participating in the 20040138 study
Exclusion Criteria
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To examine the safety profile of denosumab, including (serious) adverse events<br /><br>incidence, changes in safety laboratory values, incidence of anti-denosumab<br /><br>antibody formation during up to 5 years if treatment with denosumab.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To examine the safety profile of denosumab, including (serious) adverse events<br /><br>incidence, changes in safety laboratory values, incidence of anti-denosumab<br /><br>antibody formation during up to 2 years if treatment with denosumab.</p><br>