To study the long term safety (up to 5 years) of denosumab in subjects undergoing androgen-deprivation therapy for non-metastatic prostate cancer.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
botziekten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To examine the safety profile of denosumab, including (serious) adverse events
incidence, changes in safety laboratory values, incidence of anti-denosumab
antibody formation during up to 5 years if treatment with denosumab.
Secondary outcome
To examine the safety profile of denosumab, including (serious) adverse events
incidence, changes in safety laboratory values, incidence of anti-denosumab
antibody formation during up to 2 years if treatment with denosumab.
Background summary
In this study the experimental drug denosumab is being tested for the treatment
of bone loss in subjects undergoing androgen-deprivation therapy for
non-metastatic prostate cancer. This study is being offered to patients
currently participating in the 20040138 study. The 20040138 study demonstrates
a significant increase in bone mineral density in the investigated parts of the
bone. All patients who participate in the 20080537 study will receive denosumab
every 6 months for 2 years. The number of patients participating is dependent
on the number of patients who are currently participating in the 20040138
study. It is expected that about 500-800 patients will participate. Amgen Inc.
Is the sponsor of this study.
Study objective
To study the long term safety (up to 5 years) of denosumab in subjects
undergoing androgen-deprivation therapy for non-metastatic prostate cancer.
Study design
This is an open-label, multicenter, phase 3 study.
The study consists of 3 phases. The first part is the screening phase. The
patient will enter the treatment phase when the patient is eligible for this
study. The treatment phase ends after 24 months. After the 24 months there will
be an end of study visit. Every participating patient will receive denosumab 60
mg SC every 6 months
Intervention
All participating subjects will receive denosumab 60 mg SC every 6 months
Study burden and risks
Patients need to come to the hospital 6 times. During the treatment phase the
patient will receive subcutaneous denosumab injections on day 1, month 6, month
12 and month 18. Study visits will last for about 2 hours.
The burden and risks associated with participation are small. All participating
patients receive denosumab and therefore have a change on a positive effect
from denosumab. The 20040138 study demonstrated a significant increase in bone
mineral density in the investigated parts of the bone.
Minervum 7061
4800DH Breda
NL
Minervum 7061
4800DH Breda
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-006154-17-NL |
| ClinicalTrials.gov | NCT00838201 |
| CCMO | NL25709.008.09 |