Fractures, Osteoporosis, Prostate Cancer
Conditions
Keywords
Prostate cancer, Bone Loss, Osteoporosis, Fractures, Androgen Deprivation Therapy
Brief summary
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.
Interventions
Sponsors
GTx
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
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: * 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: * Hologic BMD (g/cm2): L1-L4 - 0.926; Femoral neck - 0.717 * Lunar BMD (g/cm2): L1-L4 - 1.050; Femoral neck - 0.840 * 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: * 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%.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects at 24 months with at least one new vertebral fracture determined by blinded central review of radiographs of the thoracic and lumbar spine | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects with at least one new or worsening vertebral fracture at 24 months | — |
| Percentage of subjects with a clinical fragility fracture at 12 and 24 months | — |
| Percent change from baseline in lumbar bone mineral density (BMD) as measured by dual energy x-ray absorptiometry (DEXA) scan at 24 months | — |
Countries
Mexico, United States
Outcome results
None listed