Osteoporosis Prevention in Prostate Cancer Patients Receiving Androgen Ablation Therapy: A Phase III Randomized, Placebo-Controlled, Double-Blind Study

Inclusion Criteria

DISEASE CHARACTERISTICS:

- History of prostate cancer

- No evidence of metastatic bony disease* NOTE: *Elevated prostate-specific
antigen (PSA) allowed

- Meets one of the following criteria:

- Currently on treatment with androgen-ablation therapy in the adjuvant setting

- Rising PSA without other evidence of recurrent disease with planned treatment
for at least 6 months

- No known osteoporosis or prior osteoporotic fracture

- Osteoporosis defined as bone density at the hip or spine of more than 2.5
standard deviations below the mean for young men

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- SGOT or SGPT no greater than 1.5 times upper limit of normal (ULN)

- Alkaline phosphatase normal OR no greater than 1.5 times ULN with a normal bone scan

Renal

- Creatinine no greater than 1.5 times ULN

- No prior symptomatic hypercalcemia or hypocalcemia

Cardiovascular

- No active heart disease

- No congestive heart failure under active treatment

- No myocardial infarction within the past 5 years

- No coronary artery disease (CAD) with recent myocardial infarction

- Patients with a remote history of CAD who are only on medical treatment (e.g.,
antilipid agents) are allowed

- No prior thrombosis (deep vein thrombosis, stroke, or pulmonary embolism) or other
known hypercoagulable state other than cancer

Other

- Fertile patients must use effective contraception

- Triglycerides no greater than 250 mg/dL (treatment allowed)

- Able to complete questionnaire(s) by self or with assistance

- Able to swallow pills

- No prior hyperlipidemia (e.g., prior familial hyperlipidemia or fasting triglyceride
greater than 250 mg/dL within the past 6 months)

- No sarcoidosis

- No parathyroid dysfunction

- No intolerance to bisphosphonates

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No concurrent chemotherapy

Endocrine therapy

- See Disease Characteristics

- No concurrent systemic steroids

Radiotherapy

- No concurrent radiotherapy

Surgery

- More than 3 months since prior and no concurrent dental extraction, root canal, or
dental implantation

Other

- No prior bisphosphonates

- More than 5 years since prior percutaneous transluminal coronary angioplasty