Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GTx
Age
50–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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 a history of thromboembolic disease including deep vein thrombosis or pulmonary embolus
Have a history of chronic hepatitis or cirrhosis
Have received prior treatment with toremifene
You may not be if
Have been on:
* ADT treatment (either luteinizing hormone-releasing agonist \[LHRHa\] or orchiectomy) for at least 6 months; Or
* Intermittent LHRHa for at least the preceding 12 months is acceptable, but subjects must be maintained on uninterrupted treatment for the duration of this study once they are randomized into the study.
Be aged ≥ 70 years or have BMD of lumbar spine or femoral neck at or below the specified thresholds for study entry:
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:
* White blood cell (WBC) count ≥ 3,000/mm3;
* Platelet count ≥ 100,000/mm3;
* Bilirubin ≤ 1.5 mg/dL;
* AST and ALT \< 2x upper limit of normal;
* Serum creatinine ≤ 2.0 mg%.
Subjects with any of the following will not be eligible for enrollment:
Taking bisphosphonates, selective estrogen receptor modulators (SERMs), parathyroid hormone (PTH), Forteo® (teriparatide), calcitonin, or oral glucocorticoids within 45 days of randomization
Have any disease or condition that would preclude an accurate evaluation of radiographs of the thoracic and lumbar spine (at least eight evaluable vertebrae in the range T4 to L4) \[for example, severe scoliosis, or sequelae of orthopedic procedures or other surgery\]
Have \> 4 vertebral fragility fractures
Have any history of other carcinomas within the last 5 years (except nonmelanoma cutaneous malignancies and superficial bladder cancer with no evidence of recurrence which will not be excluded). NOTE: Patients with cancers other than nonmelanoma cutaneous malignancies and superficial bladder cancer with no evidence of tumor recurrence for at least 5 years after definitive treatment will not be excluded from this study.
Have Paget's disease of bone
Have active systemic viral, bacterial or fungal infections requiring treatment
Have, in the judgment of the investigator, a clinically significant concurrent illness or psychological, familial, sociological, geographical or other concomitant condition that would not permit adequate follow-up and compliance with the study protocol for the full 24-month duration of the study
Received treatment with other investigational agents within 30 days prior to randomization
Clareo Health | Toremifene Citrate for Prevention of Bone Fractures in Men With Prostate Cancer on Androgen Deprivation Therapy
