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 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