Renal safety of ibandronate 6 mg infused over 15 min versus 60 min in breast cancer patients with bone metastases: a randomized open-label equivalence trial

Xavier Pivot, Alain Lortholary, Sophie Abadie-Lacourtoisie, Fawzia Mefti-Lacheraf, Eric Pujade-Lauraine, Claudia Lefeuvre, Sarah Letessier, Philippe Morvan, Carole Dür, L Frimat
Breast: Official Journal of the European Society of Mastology 2011, 20 (6): 510-4

PURPOSE: The aim of this study was to demonstrate the renal safety equivalence of ibandronate 6 mg infused over 15 min versus 60 min, in patients with bone metastases of breast cancer.

PATIENTS AND METHODS: Patients were females having breast cancer with at least one bone metastasis. Exclusion criteria were renal failure (creatinine clearance < 30 mL/min), tooth/jaw disorder or uncontrolled severe disease. Eligible patients were randomly assigned to receive nine ibandronate 6 mg i.v. infusions over either 15 min or 60 min. The primary outcome was the 95% confidence interval (CI) of the difference in creatinine clearance between groups, 28 days after the last infusion. The equivalence margin was ±8 mL/min.

RESULTS: Overall 334 patients were randomized (165-15 min infusions vs. 169 to 60 min infusions, 325 (159 vs. 166) were analyzed by intent-to-treat, and 312 (151 vs. 161) were analyzed per protocol. Per protocol, the 15 min-60 min difference in creatinine clearance [95% CI] was -3.00 [-8.18, 2.18]. By intent-to-treat, this difference was-2.91 [-7.99, 2.16]. Death and serious adverse event rates did not differ between groups. Three serious adverse events were considered related to ibandronate: an osteonecrosis of the jaw (15-min group), a pain in jaw and an enamel cracking (60-min group). Two renal failures, reported in the 60 min group, were not considered related to ibandronate. None occurred in the 15 min group.

CONCLUSION: Ibandronate may be infused over 15 min without clinically significant consequence on renal safety.

Full Text Links

Find Full Text Links for this Article


You are not logged in. Sign Up or Log In to join the discussion.

Related Papers

Remove bar
Read by QxMD icon Read

Save your favorite articles in one place with a free QxMD account.


Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"