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
A histologically confirmed diagnosis of carcinoma of the prostate
Therapy with hormonal treatments (medical or surgical castration)
Patients must have objective evidence of metastatic disease to bone.
Adequate liver function - serum total bilirubin concentration less than 1.5 x upper limit of normal value
ECOG performance status of 0, 1 or 2
You may not be if
Bone pain which requires strong narcotic therapy with centrally acting analgesic agents.
More than 3 bisphosphonate applications in patients history.
Previous Radiation therapy to bone (including therapeutic radioisotopes such as strontium 89) within 3 months prior to Visit 2.
Abnormal renal function as evidenced by
A calculated creatinine clearance \< 30 ml/minute. Creatinine clearance (CrCl) is calculated using the Cockcroft-Gault formula:
CrCl= \[140-age (years)\] x weight (kg) {x 0.85 for female patients} \[72 x serum creatinine (mg/dL)\]
Corrected (adjusted for serum albumin) serum calcium concentration \< 8.0 mg/dl (2.00 mmol/L) or ≥ 12.0 mg/dl (3.00 mmol/L)
Life expectancy \< 6 months
Patients with evidence in the six months prior to randomization of severe cardiovascular disease (defined as uncontrolled congestive heart failure), hypertension refractory to treatment, or symptomatic coronary artery disease uncontrolled by treatment
Use of other investigational drugs (drugs not marketed for any indication) within 30 days prior to the date of randomization
Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)
