Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2025-12-24 @ 10:49 PM
NCT ID:
NCT00043069
Eligibility 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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00043069
Study Brief:
Protocol Section:
NCT00043069