PURPOSE: This trial is the first to compare directly the clinical response to and safety of oral and intravenous (IV) ibandronic acid for metastatic bone disease. METHODS:Patients > or =18 years with breast, prostate, lung, urogenital or colon cancer receivedIV ibandronic acid 6 mg infused over 15 min every 28 days or oral ibandronic acid 50 mg/day. Clinical response was determined using bone scintigraphy, radiography and serum C-terminal telopeptide of typeI collagen (S-CTX) at months 3-6. Adverse events and biochemical safety measures were recorded. RESULTS: A total of 84.6 and 88.5% of patients had a complete/partial response to IV and oral ibandronic acid, respectively. Median percentage decreases in S-CTX were -39 and -35%, respectively. Bone pain scores decreased and analgesic use increased from month 0-3 and were stable from months 3-6. Both formulations improved physical and functioning scores. CONCLUSION:Oral and IV ibandronic acid for bone metastases have similar efficacy and tolerability.
RCT Entities:
PURPOSE: This trial is the first to compare directly the clinical response to and safety of oral and intravenous (IV) ibandronic acid for metastatic bone disease. METHODS:Patients > or =18 years with breast, prostate, lung, urogenital or colon cancer received IV ibandronic acid 6 mg infused over 15 min every 28 days or oral ibandronic acid 50 mg/day. Clinical response was determined using bone scintigraphy, radiography and serum C-terminal telopeptide of type I collagen (S-CTX) at months 3-6. Adverse events and biochemical safety measures were recorded. RESULTS: A total of 84.6 and 88.5% of patients had a complete/partial response to IV and oral ibandronic acid, respectively. Median percentage decreases in S-CTX were -39 and -35%, respectively. Bone pain scores decreased and analgesic use increased from month 0-3 and were stable from months 3-6. Both formulations improved physical and functioning scores. CONCLUSION: Oral and IV ibandronic acid for bone metastases have similar efficacy and tolerability.
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