Zoledronic Acid With Intermittent Hormonal Therapy in Patients With Prostate Cancer
Status and phase
Conditions
Treatments
Details and patient eligibility
About
Primary:
To determine the duration of use of zoledronic acid in improving Bone mineral density in patients with prostate cancer who are on hormones intermittently.
Secondary Objectives:
To describe the safety and tolerability at this dose and schedule
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria:Patients: Who are 18 years of age and older Who have histologically documented adenocarcinoma of prostate Who are currently receiving LHRH agonists KPS greater than 80%Life expectancy greater than 6 months Provide written consent pursuant to regulatory requirements prior to initiation of study procedure Exclusion Criteria:Exclusion Criteria: Patients: Any patient requiring continuous LHRH Any patient who has had an orchiectomy Any patient with painful bone metastases Who have received chemotherapy for prostate cancer Who have a abnormal serum creatine >2.5 Receiving any investigational drug within the last 28 days Severe uncontrolled infection, diabetes, cardiac disease Patients with fragility fractures, hyperparathyroidism, Pagets renal osteodystrophy will be excluded History of non compliance to medical regimens or unwillingness to return for medical visits
Trial design
Primary purpose
Allocation
Interventional model
Masking
23 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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