Calcium With or Without Estrogen and/or Risedronate in Preventing Osteoporosis in Patients With Prostate Cancer

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

RATIONALE: Preventing bone loss in patients who are undergoing androgen ablation for prostate cancer may decrease the risk of fractures and may help patients live more comfortably. It is not yet known whether calcium is more effective with or without estrogen and/or risedronate in preventing osteoporosis.

PURPOSE: Randomized phase III trial to compare the effectiveness of two forms of calcium with or without estrogen and/or risedronate in preventing osteoporosis in patients with prostate cancer who are receiving androgen ablation therapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Calcium Carbonate; Calcium, Dietary; Cholecalciferol; Estrogen Antagonists; Estrogen Receptor Antagonists; Estrogens; Etidronic Acid; Risedronate Sodium; Risedronic Acid

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