Calcium With or Without Estrogen and/or Risedronate in Preventing Osteoporosis in Patients With P… (NCT00043069) | Clinical Trial Compass
CompletedPhase 3
Calcium With or Without Estrogen and/or Risedronate in Preventing Osteoporosis in Patients With Prostate Cancer
United States71 participantsStarted 2002-11
Plain-language 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.
Who can participate
Age range18 Years
SexMALE
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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 contrac…