DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Renal safety profiles of ibandronate 6 mg infused over 15 and 60 min: a randomized, open-label study.

Author(s): von Moos R, Caspar CB, Thurlimann B, Angst R, Inauen R, Greil R, Bergstrom B, Schmieding K, Pecherstorfer M

Affiliation(s): Kantonsspital Graubunden, Chur, Switzerland. roger.vonmoos@onkologie.li

Publication date & source: 2008-07, Ann Oncol., 19(7):1266-70. Epub 2008 Mar 11.

Publication type: Clinical Trial, Phase II; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

BACKGROUND: Clinical data show that a single, 15-min i.v. infusion of ibandronate 6 mg does not significantly alter renal function. We evaluated the effect on renal function of repeated 15-min infusions of ibandronate 6 mg in women with breast cancer and bone metastases. PATIENTS AND METHODS: Patients were randomly assigned to i.v. ibandronate 6 mg every 3-4 weeks for < or =6 months, infusion over 15 min (n = 102) or 60 min (n = 28). The primary end point was the percentage of patients with increased serum creatinine of > or =44.2 micromol/l. Blood chemistry was assessed at each visit. RESULTS: Two per cent [2/101; 95% confidence interval (CI) 0.2-7.0] of patients in the 15-min infusion arm and no patients (0/26; 95% CI 0.0-13.2) in the 60-min infusion arm had increased serum creatinine that met the primary end point. There were no clinically relevant changes in serum creatinine, creatinine clearance, or N-acetyl-beta-d-glucosaminidase, alpha(1)-microglobulin, or microalbuminuria. Most adverse events were mild or moderate. No clinically relevant changes were observed in vital signs, hematology, blood chemistry, or urine analysis. CONCLUSIONS: Ibandronate 6 mg by 15-min infusion every 3-4 weeks appear to be consistent with those renal safety profiles of 60-min infusion.

Page last updated: 2008-11-03

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017