Efficacy and Safety Study of Toremifene Citrate for the Reduction in the Risk of New Bone Fracture Occurrences in Men With Prostate Cancer

Inclusion Criteria: * give voluntary signed informed consent * have histologically documented prostate cancer * have been on ADT treatment for 6 months prior to randomization or intermittent LHRHa for preceeding 12 months * expected to continue LHRHa therapy uninterrupted for the next 12 months * have total testosterone levels less than 50 ng/dL * Have BMD of lumbar spine or femoral neck at or below the BMD thresholds * have a Zubrod performance status \<or equal to 1 * subject weight \<300 lbs(\<136 kg) * agree to complete a daily diary of medication intake * agree not to take excluded medications throughout the trial * agree to use an effective method of contraception * have adequate bone marrow, liver and renal functions Exclusion Criteria: * Currently or previously exposed * within the past 5 years to intravenous bisphosphonates, strontium ranelate or Denosumab * for more than 3 years to oral bisphosphonates * within the last 45 days to PTH or PTH derivative, anabolic steroids or testosterone, SERMs, calcitonin, calcitriol or oral gluccorticoids * have any disease or condition that would preclude an accurate evaluation of radiographs of the thoracic or lumbar spine * have \<8 evaluable vertebrae * have a BMD T score \<-4 at the lumbar spine or total hip or femoral neck * have any history of other carcinomas within the last 5 years * Serum PSA \> 5ng/mL at baseline under ADT * have Paget's disease, Cushing's disease, chronic hepatitis or cirrhosis or rheumatoid arthritis * have active uncontrolled systemic viral, bacterial or fungal infections * have a clinically significant concurrent illness or psychological, familial, sociological, geograhical or other condition that would not permit adequate follow-up and compliance * received treatment with other investigational agents within 30 days * taking finasteride, dutasteride, danazol or testosterone like substances * taking herbal medicines or dietary supplements * have a history of thromboembolic disease including DVT or pulmonary embolus * have a QTcF of \> or equal to 450 msec or congenital or acquired QTc prolongation * have HIV * calcicum urolithiasis prohibiting the use of vitamin D