Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Signed informed consent
Age \> 18 years
Histologically confirmed diagnosis of carcinoma of the prostate
No distant metastases at the start of ADT and continuously low PSA (\<2.0) on continuous ADT (stage Tany Nany MO).
Patients initiating or receiving ADT with a LHRH agonist (with or without an antiandrogen) and with the intended duration of ADT of at least 12 months at the time of randomization. Patients undergoing bilateral orchiectomy or with history of this procedure are also eligible.
Patient with a baseline BMD T-score at or above -2.0 standard deviations in the lumbar spine (L2-L4) and the total hip are eligible
Life expectancy of at least 12 months
Zubrod performance status of 0, 1, or 2
You may not be if
Patients who received any prior bisphosphonate therapy in the past 6 months
Metabolic bone disease including Paget's disease or hyperparathyroidism
Radiographic evidence of bone metastases
Patients who have received prior treatment with systemic corticosteroids within the past 12 months (short term corticosteroid therapy, e.g. to prevent/treat chemotherapy-induced nausea/vomiting or for acute illness like asthma exacerbation, is acceptable)
Patients with prior exposure to anabolic steroids or growth hormone within the past 6 months
Current treatment with estrogen or complementary medicines known to contain estrogens
Patients with clinical or radiological evidence of existing fracture in the lumbar spine and/or total hip
Patients with a history of fracture with low-intensity or no associated trauma
Patients with any prior treatment for osteoporosis
Patients with previous or concomitant malignancy within the past 5 years except adequately treated basal or squamous cell carcinoma of the skin, and colonic polyps with non-invasive malignancy which have been removed
Patients with nonmalignant conditions which would confound the evaluation of the primary endpoint, impair tolerance of therapy, or prevent compliance to the protocol, including:
* uncontrolled infections
* uncontrolled type 2 diabetes mellitus
* diseases with influence on bone metabolism, such as Paget's disease or uncontrolled thyroid or parathyroid dysfunction
* cardiovascular, renal, hepatic, pulmonary and neurologic/psychiatric diseases which would prevent prolonged follow-up
History of surgery at the lumbosacral spine, with or without implantable devices, bilateral hip replacement or bilateral hip surgery with implantation of an appliance
Patients treated with systemic investigational drugs(s) and /or device(s) within the past 30 days
Patients with abnormal renal function as evidenced by either a serum creatinine greater than 3 mg/dL or by a calculated creatinine clearance of 60 ml/minute or less
