TREAT2: Efficacy and Safety Study of Toremifene Citrate for the Reduction in the Risk of New Bone Fracture Occurrences in Men With Prostate Cancer

Sponsor

GTx (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT01214291

Collaborator

Ipsen (Industry)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether Toremifene Citrate is effective in reducing the risk of bone fractures in men with prostate cancer who are on Androgen Deprivation Therapy.

Condition or Disease	Intervention/Treatment	Phase
Risk of Bone Fracture Occurrences	Drug: Toremifene	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Official Title:

Phase III Randomized, Double-Blind, Placebo Controlled, Multicenter Efficacy and Safety Study of Toremifene Citrate 80 mg for the Reduction in the Risk of New Bone Fracture Occurrences in Men With Prostate Cancer on Androgen Deprivation Therapy

Study Start Date :

Mar 1, 2011

Actual Primary Completion Date :

Sep 1, 2011

Actual Study Completion Date :

Sep 1, 2011

Outcome Measures

Primary Outcome Measures

To confirm the efficacy of toremifene 80mg compared with placebo in the reduction in the risk of new bone fracture occurrences in men with prostate cancer on androgen deprivation therapy as measured by semiquantitative assessment of vertebral fractures [36 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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