Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases

Body, Jean‐Jacques; Diel, Ingo J.; Личиницер, М. Р.; Kreuser, E. D.; Dornoff, W.; Gorbunova, Vera; Budde, M.; Bergström, B.

doi:10.1093/annonc/mdg367

Cited by 374 publications

(89 citation statements)

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“…The results for fractures did not reach statistical significance in contrast to the data for i.v. ibandronate (Body et al, 2003a), and the patients had overall less fractures in the oral studies. Since a large meta-analysis of clinical trials has shown that bisphosphonates significantly decrease skeletal morbidity including fractures and need for radiotherapy (Ross et al, 2003), the trend that was observed for oral ibandronate will need to be confirmed in larger studies.…”

Section: Discussionmentioning

confidence: 81%

“…As demonstrated for i.v. ibandronate (Body et al, 2003a;Lyubimova et al, 2003), oral ibandronate was not associated with renal AEs. This contrasts with the enhanced risk of renal AEs reported with i.v.…”

Section: Discussionmentioning

confidence: 86%

“…As reported elsewhere, the i.v. formulation of ibandronate (6 mg infused every 3 -4 weeks) has been shown to reduce significantly the risk of skeletal complications, alleviate bone pain and improve quality of life in patients with metastatic breast cancer, in the absence of renal safety concerns (Body et al, 2003a, b;Diel et al, 2003;Tripathy et al, 2003). This paper presents the results of a pooled analysis of two phase III clinical trials that assessed the efficacy and safety of oral ibandronate (50 mg day À1 ) in the treatment of women with breast cancer and bone metastases.…”

Section: Intravenousmentioning

confidence: 99%

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Oral ibandronate reduces the risk of skeletal complications in breast cancer patients with metastatic bone disease: results from two randomised, placebo-controlled phase III studies

Diel²,

et al. 2004

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Although intravenous (i.v.) bisphosphonates are the standard of care for metastatic bone disease, they are less than ideal for many patients due to infusion-related adverse events (AEs), an increased risk of renal toxicity and the inconvenience of regular hospital visits. The use of oral bisphosphonate therapy is limited by concerns over efficacy and gastrointestinal (GI) side effects. There remains a clinical need for an oral bisphosphonate that offers equivalent efficacy to i.v. bisphosphonates, good tolerability and dosing convenience. Oral ibandronate, a highly potent, third-generation aminobisphosphonate, has been evaluated in phase III clinical trials of patients with bone metastases from breast cancer. In two pooled phase III studies, patients with breast cancer and bone metastases were randomised to receive oral ibandronate 50 mg (n ¼ 287) or placebo (n ¼ 277) once daily for up to 96 weeks. The primary end point was the skeletal morbidity period rate (SMPR), defined as the number of 12-week periods with new skeletal complications. Multivariate Poisson's regression analysis was used to assess the relative risk of skeletal-related events in each treatment group during the study period. Oral ibandronate 50 mg significantly reduced the mean SMPR compared with placebo (0.95 vs 1.18, P ¼ 0.004). There was a significant reduction in the mean number of events requiring radiotherapy (0.73 vs 0.98, Po0.001) and events requiring surgery (0.47 vs 0.53, P ¼ 0.037). Poisson's regression analysis confirmed that oral ibandronate significantly reduced the risk of a skeletal event compared with placebo (hazard ratio 0.62, 95% CI ¼ 0.48, 0.79; P ¼ 0.0001). The incidence of mild treatment-related upper GI AEs was slightly higher in the oral ibandronate 50 mg group compared with placebo, but very few serious drug-related AEs were reported. Oral ibandronate 50 mg is an effective, well-tolerated and convenient treatment for the prevention of skeletal complications of metastatic bone disease.

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Section: Discussionmentioning

confidence: 81%

Section: Discussionmentioning

confidence: 86%

Section: Intravenousmentioning

confidence: 99%

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Oral ibandronate reduces the risk of skeletal complications in breast cancer patients with metastatic bone disease: results from two randomised, placebo-controlled phase III studies

Diel²,

et al. 2004

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“…Of these 31 studies, 6 reported on bone metastases from breast cancer, [71][72][73][74][75][76] 13 reported on bone metastases from prostate cancer [77][78][79][80][81][82][83][84][85][86][87][88][89] and 12 reported on bone metastases from OSTs. [90][91][92][93][94][95][96][97][98][99][100][101] Of the remaining eight studies that did contribute data to the network meta-analyses, four reported breast cancer 31,[102][103][104] [18 reports 22,31,[102][103][104][105][106][107][108][109][110][111][112][113][11...…”

Section: Number and Type Of Studies Includedmentioning

confidence: 99%

Systematic review of the clinical effectiveness and cost-effectiveness, and economic evaluation, of denosumab for the treatment of bone metastases from solid tumours

Ford

Cummins²,

Sharma³

et al. 2013

Health Technol Assess

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“…There have been no published reports of ibandronate-related renal failure in this indication [29]. Intravenous ibandronate (6 mg infused every 3–4 weeks) has also been shown to be effective and well tolerated as a treatment for hypercalcemia and other complications of malignant bone disease, such as fractures and bone pain [12, 30, 31]. …”

Section: Introductionmentioning

confidence: 99%

Ibandronate for the Treatment of Hypercalcemia or Nephrocalcinosis in Patients with Multiple Myeloma and Acute Renal Failure: Case Reports

et al. 2006

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Multiple myeloma disrupts calcium homeostasis by a variety of mechanisms, including bone destruction and resorption. This causes hypercalcemia. When left untreated, hypercalcemia leads to nephrocalcinosis, impairment of kidney function, and eventually renal failure. Some degree of renal dysfunction is common in myeloma patients. Here, we report case studies showing the efficacy and renal safety of the single-nitrogen bisphosphonate, ibandronate, for the treatment of hypercalcemia and/or nephrocalcinosis in multiple myeloma patients hospitalized with acute renal failure. Patients (n = 7) received either one or two intravenous infusions of ibandronate (2–6 mg). Ibandronate was well tolerated in all patients and returned elevated blood calcium levels to normal. Renal function improved for all patients and normalized in 3/7 patients. We conclude that ibandronate is involved in rapidly improving or restoring acute renal function and calcium levels to within the normal range in this patient population. To clarify the exact value of ibandronate, further investigation is warranted in randomized prospective trials.

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Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases

Abstract: These results indicate that 6 mg i.v. ibandronate is effective and safe in the treatment of bone metastases from breast cancer.

Cited by 374 publications

References 20 publications

Oral ibandronate reduces the risk of skeletal complications in breast cancer patients with metastatic bone disease: results from two randomised, placebo-controlled phase III studies

Oral ibandronate reduces the risk of skeletal complications in breast cancer patients with metastatic bone disease: results from two randomised, placebo-controlled phase III studies

Systematic review of the clinical effectiveness and cost-effectiveness, and economic evaluation, of denosumab for the treatment of bone metastases from solid tumours

Ibandronate for the Treatment of Hypercalcemia or Nephrocalcinosis in Patients with Multiple Myeloma and Acute Renal Failure: Case Reports

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