A Randomized, Single-blind, Placebo-controlled, Multicentre Study to Evaluate the Effect of Risedronate and Placebo on Bone Mineral Density in Men Undergoing Androgen Deprivation Therapy With Leuprolide Acetate
- Patients over 18 years of age.
- Histologically confirmed diagnosis of prostate cancer without metastases.
- Patient must have negative bone scan to rule out bone metastases.
- Patient for whom androgen deprivation therapy with leuprolide acetate is indicated
for at least 1 year.
- Eastern Cooperative Oncology Group (ECOG) score of 0 - 2.
- Study medication must be started within 3 months of initiation of ADT.
- Signed written informed consent.
- Prior ADT (greater than 3 months).
- History of treatment with calcitriol or bisphosphonates.
- Suppressive doses of thyroxine within the previous year.
- Concomitant or prior history of long-term treatment (greater than or equal to 3
months) with systemic glucocorticoids.
- Evidence of any of the following conditions per subject self-report or chart review:
Current hyper- or hypothyroidism (stable on thyroid replacement therapy is allowed, if TSH
is within normal reference range).
Paget's disease, Cushing's disease, hyperprolactinemia, chronic liver disease. Unstable
systemic disease including active infection, uncontrolled hypertension, unstable angina,
congestive heart failure, or myocardial infarction within 6 months before randomization.
Major surgery or significant traumatic injury occurring within 1 month prior to
- Known hypersensitivity to leuprolide acetate or any of the components found in
- Any concurrent condition that would make it undesirable, in the physician's opinion,
for the subject to participate in the study or would jeopardize compliance with the