143
Participants
Start Date
August 31, 2000
Primary Completion Date
November 30, 2008
Study Completion Date
November 30, 2008
Zoledronic acid
Zoledronic acid administered via normal saline intravenous infusion (over 15 minutes) every 4 weeks. Dosage was according to calculated creatinine clearance: patients with baseline creatinine clearance \> 60 ml/min received 4 mg; for patients with mild to moderate renal impairment, doses were calculated to achieve the same AUC as that achieved in patients with creatinine clearance of 75 ml/min, assuming target AUC of 0.66 (mg\*hr/l).
Calcium / Vitamin D
Patients on zoledronic acid received 500 mg calcium and 400-500 IU vitamin D combination tablet daily.
Novartis Investigative Site, Berlin
Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY