14 results
To determine if denosumab is non-inferior to zoledronic acid (Zometa) with respect to the first on-study occurrence of a skeletal-related event (SRE) in men with hormone-refractory prostate cancer and bone metastases.
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 provide, or continue to provide, UT-15C SR for eligible subjects who participated in protocols TDE-PH-301 or TDE-PH-302 or TDE-PH-308 or additional UC-15C SR clinical protocols.To assess the long-term safety of UT-15C SR in these subjects through…
To determine if denosumab is non-inferior to zoledronic acid (Zometa) with respect to the first on-study occurrence of a skeletal-related event (SRE) in subjects with advanced breast cancer and bone metastases.
To evaluate the safety and efficacy of EVICEL for use as an adjunct to dura sutures in elective cranial surgery to provide intraoperative watertight closure.
To study the long term safety (up to 5 years) of denosumab in subjects undergoing androgen-deprivation therapy for non-metastatic prostate cancer.
To determine if denosumab is non-inferior to zoledronic acid with respect to the first on-study occurrence of a skeletal related event (SRE) in subjects with advanced cancers and bone metastases (or lytic bone lesions from multiple myeloma).SRE is…
Primary: To assess the effect of UT-15C sustained release (SR) on exercise capacity compared to placebo (as measured by the change in 6-Minute Walk distance from Baseline to Week 16) in subjects with PAH.Secondary: To assess the effect of UT-15C SR…
The objective of the study is to evaluate the safety profile of denosumab in subjects with Giant Cell Tumor of bone.
The primary objective in the glucocorticoid-continuing subpopulation of men and women treated with chronic glucocorticoid therapy (>= 7.5 mg daily prednisone or its equivalent for >= 3 months and are planning to continue treatment for…
This study will be carried out to gain more knowledge about denosumab in patientes with NSCLC. The effect of denosumab in combination with platinum-doublet chemotherapy in patients with NSCLC and the relation with the presence of biomarkers in…
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…
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 purpose of this research study is to evaluate how safe and effective Denosumab is, compared with placebo, in delaying the time it takes for cancer to spread to the bones in subjects with early-stage breast cancer at high risk of recurrence.The…