7 results
The primary objective of the study is to evaluate the effect of denosumab 60mg every 6 months (Q6M) compared with Actonel 150mg monthly (QM) on total hip Bone Mineral Density (BMD) at 12 months in postmenopausal women transitioning from previous…
To study the long term safety (up to 5 years) of denosumab in subjects undergoing androgen-deprivation therapy for non-metastatic prostate cancer.
To describe the safety and tolerability of up to 5 years denosumab administration as measured by adverse event monitoring, immunogenicity, and safety laboratory parameters in subjects who previously received denosumab.
Primary objective• Determine the change in intratumoral T-cell (CD4, CD8 and Treg) and Myeloid cell (M1/M2 Macrophage, MDSC, DC) numbers and function between the baseline biopsy and the surgical specimen.Secondary objectives• PBMC before start…
Primary:Subjects with salvageable giant cell rich tumors:- To evaluate subjects who do not require surgery during the study- To evaluate subjects who are able to undergo a less morbid surgical procedure compared with the planned surgical procedure…
The objective of the study is to evaluate the safety profile of denosumab in subjects with Giant Cell Tumor of bone.
The primary objective of the trial is to evaluate the risk versus benefit of denosumab in maintenance setting in patients requiring long-use (>1 year) of denosumab. For that purpose, the treatment schedule with reduced dose density (120mg SC…