A Randomized, Double Blind, Placebo Controlled, Multicenter Efficacy and Safety Study of Toremifene Citrate for Prevention of Bone Fractures in Men With Prostate Cancer on Androgen Deprivation Therapy
A Randomized, Double Blind, Placebo Controlled, Multicenter Efficacy and Safety Study of Toremifene Citrate for Prevention of Bone Fractures in Men With Prostate Cancer on Androgen Deprivation Therapy
Androgen deprivation therapy (ADT) treatment for prostate cancer decreases the natural hormone called testosterone. This type of therapy is very effective for the treatment of prostate cancer. However, one of the side effects is bone loss or thinning of the bones that can lead to osteoporosis and an increased risk of bone fractures (breaking of the bones). The purpose of the study is to determine whether or not the addition of toremifene citrate (the study drug) to therapy can prevent or decrease the number of bone fractures and to evaluate its impact on side effects associated with testosterone reduction therapy.
Inclusion Criteria:
To be eligible for participation in this study, subjects must meet all of the following criteria (minor deviations may be discussed with the medical monitor for possible inclusions):
Give voluntary, signed informed consent in accordance with institutional policies
Be male, aged ≥ 50 years
Have histologically documented prostate cancer. Subjects with metastatic prostate cancer may still be considered for the study as long as they are not disqualified by other inclusion/exclusion criteria and there is a reasonable expectation that their medical condition will not interfere with the objectives of the study and that adequate follow-up and compliance with the study protocol can be achieved for the full 24-month duration of the study.
Have been on:
Be aged ≥ 70 years or have BMD of lumbar spine or femoral neck at or below the specified thresholds for study entry:
Serum prostate-specific antigen (PSA) ≤ 4 ng/mL
Have a Zubrod performance status ≤ 1
Subject weight < 300 lbs (weight limitation of DEXA equipment)
Agree to complete a daily diary of medication intake and to provide tablet containers for accurate counts
Agree to use an effective method of contraception, if the partner is of childbearing age, while on study
Have adequate bone marrow, liver and renal function:
Exclusion Criteria:
Subjects with any of the following will not be eligible for enrollment:
San Bernadino, California 92404, United States
Trumball, Connecticut 06611, United States
Baltimore, Maryland 21201, United States