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| |  Oral Bisphosphonate Bondronat (Ibandronate) as Effective as IV Zometa (Zoledronic Acid) in First Head-to-Head Study in Metastatic Bone Disease ORLANDO, FL -- June 3, 2005 -- Data announced at the American Society of Clinical Oncology (ASCO) meeting in Orlando, Florida, demonstrates that oral Bondronat(R) (ibandronate) is as effective as i.v. zoledronic acid (Zometa) at suppressing bone turnover markers, according to the first head-to-head study using these markers as a surrogate measure of clinical efficacy. The results of this head-to-head study indicate that a convenient 50 mg oral dose of Bondronat is as effective as intravenously administered zoledronic acid in suppressing tumour induced bone damage. The data show for both drugs a similar decrease in S-CTX, a sensitive marker of bone resorption; ibandronate achieved -- 76% vs zoledronic acid which achieved -- 73%. Bone markers, biochemical markers that indicate the extent of skeletal turnover, are widely recognised as a valid measure of predicting and monitoring bone damage, known as skeletal-related events (e.g. fractures or spinal cord compression). These events are a frequent consequence of metastatic bone disease, the spread of cancerous cells from the original tumour to the bone. Oral option provides both efficacy and convenience This data supports the proven efficacy and potency of Bondronat to be comparable to i.v. bisphosphonates. The data from the head-to-head study now convincingly shows Bondronat is an effective oral option unlike older generation oral bisphosphonates that are not as potent. Commenting on the study, lead investigator Professor Jean-Jacques Body from the Institut Jules Bordet in Belgium, said: "These findings indicate that doctors and patients today have a new oral treatment option that provides greater flexibility and convenience in its administration, avoiding the need for patients to go to the hospital or clinic every 3-4 weeks for i.v. therapy." Study Design In the 12 week, open-label study advanced breast cancer patients were randomized into two arms: one arm (n=128) receiving 50 mg oral Bondronat daily, the other arm (n=126) receiving 4 mg zoledronic acid via 15 minute infusion every 4 weeks. Primary endpoint was reduction in a marker of bone resorption (S-CTX) at week 12 compared with baseline. The results showed a similar decrease in the marker of bone resorption (S-CTX): mean (CI) percent changes from baseline over a 12-week period: ibandronate –76% vs zoledronic acid –73%. Efficacy similar to zoledronic acid was also seen on other bone markers: serum bone specific alkaline phosphotase (BAP), the amino-terminal procollagen propeptides of type 1 collagen (P1NP) and osteocalcin (OC). In another study also presented at ASCO, a rapid decrease of S-CTX with oral Bondronat (preceded by a single i.v. Bondronat infusion) was seen by week 2 (–77%) and maintained at week 12 (–71%). Bondronat(R) (ibandronate) 1. Body JJ et al. Effect of oral ibandronate versus intravenous zoledronic acid on markers of bone resorption in patients with breast cancer and bone 2. Berthold F et al. Markers of bone remodelling in metastatic bone disease. The Journal of Clinical Endocrinology & Metabolism, 2003. 88 3. Body JJ et al. Oral ibandronate preceded by an intravenous (i.v.) ibandronate loading dose in patients with breast cancer and bone metastases or multiple myeloma: phase III results. Poster presented at the Association of Clinical Oncology (ASCO), Orlando, Florida, May 2005
SOURCE: Roche
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