Safety Of Ibandronate In Patients Research Articles

AB1012 The efficacy and safety of ibandronate in patients with osteoporosis – importance of risk factors and fractures

BackgroundTreatment of osteoporosis may be expected to affect the remodelling phase of bone repair and therefore promote fracture healing. Ibandronat significantly increase bone mineral density (BMD) and reduce the risk...

Efficacy of ibandronate for the treatment of skeletal events in patients with metastatic breast cancer

Patients with breast carcinoma often develop bone metastases that carry a high risk of complications. A randomized, placebo-controlled trial was conducted to evaluate the efficacy and safety of ibandronate in patients with metastatic bone disease following breast cancer. The primary efficacy end point of the study was the proportion of patients who developed skeletal-related events (SREs, defined as pathologic fracture, spinal cord compression, radiation therapy to bone, change in anti-neoplastic therapy and surgery to bone). Secondary end points included time to first skeletal event, skeletal morbidity rate (events/year) and time to progression of bone lesions. In 150 patients (148 [female symbol] / 2 [male symbol]) with breast carcinoma and bone metastases, treatment with intravenous ibandronate 6 mg over 15 min every 4 weeks for 24 months significantly reduced the proportion of patients who experienced an SRE compared with placebo (36% vs. 48%; P = 0.027). Time to first SRE was also delayed significantly (median 457 vs. 304 days; P = 0.007). Multiple event analysis showed that ibandronate reduced the risk of developing an SRE by 32% (hazard ratio = 0.69; 95% confidence interval 0.42-0.79; P = 0.003). In general, ibandronate was well tolerated with very rare grade 3 or 4 toxicity. In this study, ibandronate was shown to be significantly more effective than placebo as a treatment for metastatic bone disease from breast cancer using multiple end points.

Renal Safety and Pharmacokinetics of Ibandronate in Multiple Myeloma Patients With or Without Impaired Renal Function

In this open-label study, the authors assessed the pharmacokinetics and safety of ibandronate in patients with multiple myeloma and varying renal function. Renal deterioration was graded at baseline depending on creatinine clearance in 4 stages (0: >80; 1: 50-79; 2: 30-49, and 3: <30 mL/min). Patients (n = 40) received intravenous ibandronate 6 mg (30-minute infusion). Ibandronate excretion and serum levels were measured over 24 hours. Serum creatinine, creatinine clearance, and markers of tubular damage were monitored before ibandronate infusion and at 24 and 72 hours following ibandronate infusion. Ibandronate clearance, AUC(0-24), AUC(0-infinity), serum t((1/2)), and C(max) were calculated. There was a significant positive correlation between ibandronate clearance and creatinine clearance (r = 0.858; P < .00001). The AUC for grade 3 renal insufficiency increased by approximately 60% versus grade 0 (P < .01) but was not significantly different between other grades of renal function. The t((1/2)) did not increase significantly, and peak serum levels of ibandronate were similar for the 4 grades of renal function. Serum creatinine, creatinine clearance, and markers of tubular damage did not change significantly within 72 hours of ibandronate infusion. Despite renal function already being compromised in this patient group, there was no evidence of acute nephrotoxicity with ibandronate.

Ibandronate is effective in preventing skeletal events in patients with bone metastases from colorectal cancer

Patients with metastatic colorectal carcinoma (CRC) often develop bone metastases with a high risk of complications. Ibandronate is a novel single-nitrogen bisphosphonate that has been shown to be effective for treating bone metastases from breast cancer. A randomized, placebo-controlled trial was conducted to evaluate the efficacy and safety of ibandronate in patients with bone metastases from CRC. The primary efficacy end point was the proportion of patients with skeletal-related events (defined as pathologic fracture, spinal cord compression, radiation therapy to bone, change in antineoplastic therapy or surgery to bone). Secondary end points included time to first skeletal event, skeletal morbidity rate (events/year) and time to progression of bone lesions. In 73 patients with CRC, treatment with intravenous ibandronate 6 mg administered via a 15-min infusion significantly reduced the proportion of patients with skeletal events (39% vs. 78% with placebo; P = 0.019) and prolonged the time to first event by at least 6 months (median >279 vs. 93 days with placebo; P = 0.009). Ibandronate also significantly reduced the skeletal morbidity rate (mean 2.36 vs. 3.14 with placebo; P = 0.018) and prolonged time to progression of bone lesions (214 days vs. 81 days with placebo; P = 0.018). Ibandronate was well tolerated with very rare grade 3 or 4 toxicity. Furthermore, the incidence of renal adverse events was comparable with placebo and there were no clinically relevant changes in serum creatinine. Ibandronate provided significant clinical benefits for patients with bone metastases secondary to CRC. These results indicate that ibandronate may be an effective treatment for patients with metastatic bone disease following CRC. Larger studies are required for further assessment.

Renal safety of ibandronate in patients with relapsed and refractory multiple myeloma

Renal safety of ibandronate in patients with relapsed and refractory multiple myeloma

Ibandronate is effective in preventing skeletal events in patients with bone metastases secondary to colorectal carcinoma

3639 Background: Patients with metastatic colorectal carcinoma (CRC) often develop metastases to bone with a high risk of complications. Methods: A randomized, placebo-controlled trial was conducted to evaluate the efficacy and safety of ibandronate in patients with bone metastases from CRC. The primary efficacy endpoint was proportion of patients with skeletal related events (defined as pathologic fracture, spinal cord compression, radiation therapy to bone, change in antineoplastic therapy and surgery to bone). Secondary endpoints included time to first skeletal event, skeletal morbidity rate (events/year) and time to progression of bone lesions. Results: In 30 patients with CRC, treatment with intravenous ibandronate 6mg over a15-minute infusion significantly reduced the proportion of patients with skeletal events (39% versus 78% with placebo; p=0.019) and prolonged the time to first event by at least 6 months (median >279 versus 93 days with placebo; p=0.009). Ibandronate also significantly reduced the skeletal morbidity rate (mean 2.36 versus 3.14 with placebo; p=0.018) and prolonged time to progression of bone lesions (214 days versus 81 days with placebo; p=0.018). Ibandronate was well tolerated with very rare grade 3 or 4 toxicity. The incidence of renal adverse events was comparable to placebo and there were no clinically-relevant changes of serum creatinine. Conclusion: Ibandronate provided significant clinical benefit in patients with bone metastases secondary to CRC. This small pilot study suggests a role for ibandronate in metastatic bone disease from colorectal carcinoma. Larger confirmatory studies are required. No significant financial relationships to disclose.

Renal safety of ibandronate in patients with bone metastases from breast cancer: phase III trial results

Renal safety of ibandronate in patients with bone metastases from breast cancer: phase III trial results

Long-term safety of oral ibandronate in patients with skeletal metastases from breast cancer: 4-year follow-up data

Long-term safety of oral ibandronate in patients with skeletal metastases from breast cancer: 4-year follow-up data