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


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.
von Moos
R
R
Kantonsspital Graubünden, Chur, Switzerland. Electronic address: roger.vonmoos@onkologie.li.
Caspar
C B
CB
Kantonsspital Baden, Baden, Switzerland.
Thürlimann
B
B
Kantonsspital St Gallen, St Gallen, Switzerland.
Angst
R
R
Kantonsspital St Gallen, St Gallen, Switzerland.
Inauen
R
R
Kantonsspital Graubünden, Chur, Switzerland.
Greil
R
R
University Hospital, Salzburg, Austria.
Bergstrom
B
B
Hoffmann-La Roche Inc., Nutley, NJ, USA.
Schmieding
K
K
Roche Pharma (Schweiz) AG, Reinach, Switzerland.
Pecherstorfer
M
M
Wilhelminenspital, Vienna, Austria.
D050071:Bone Density Conservation Agents / Q000008:administration & dosage*; D001859:Bone Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000556:secondary*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003404:Creatinine / Q000097:blood; D004164:Diphosphonates / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000077557:Ibandronic Acid; D007262:Infusions, Intravenous; D007677:Kidney Function Tests; D009362:Neoplasm Metastasis / Q000188:drug therapy / Q000473:pathology; D011897:Random Allocation; D013997:Time Factors; D016896:Treatment Outcome
D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D003404:Creatinine; D000077557:Ibandronic Acid