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| |  Zoledronic Acid Offers Remission for Patients With Paget's Disease: Presented at ASBMR By Louise Gagnon MONTREAL -- September 14, 2008 -- Zoledronic acid demonstrates significant benefit in patients with Paget's disease, according to research presented here at the American Society for Bone and Mineral Research (ASBMR) 30th Annual Meeting. "We know that zoledronic acid has benefit [in] patients with osteoporosis, and we wanted to examine its impact on patients with Paget's disease," said principal investigator Joseph Tucci, MD, Roger Williams Medical Center, Providence, Rhode Island, and Boston University School of Medicine, Boston, Massachusetts. The study, presented here at a poster session on September 14, examined 12 patients (6 male, 6 female) who had radiologically confirmed Paget's disease, serum alkaline phosphatase (AP) results at least 50% greater than the upper limit of normal, and creatinine clearance of greater than 35 mL/min. Investigators sought to evaluate a therapeutic response, defined as normalised AP levels or a decrease of at least 75% in excess AP. As a secondary endpoint, they examined whether the levels of type-I collagen N-telopeptide in urine (U-NTx) changed to normal ranges. Zoledronic acid (5 mg) was infused over a 15-minute period. Patients were contacted by phone and asked about any postinfusion symptoms. They also received supplements of 1.5 g of calcium and at least 600 IU of vitamin D on a daily basis. At study entry, serum calcium, phosphate, and 25-hydroxyvitamin D (25-OHD) levels were normal. Mean creatinine clearance was 64 mL/min. Investigators measured mean serum calcium 9 to 11 days after therapy and found that it had fallen from 9.5 mg/dL to 8.9 mg/dL. AP levels normalised in all patients except one within 6 months, with excess AP decreasing 72% to 100% in all patients. Additionally, serum 25-OHD levels did not change significantly from baseline to the 6-month mark. At 16 months, AP levels remained normal in 9 patients, as did U-NTx/creatinine levels. At 20 months, 9 of 12 subjects continued to have remission. A minority of patients (n = 3) had flu-like symptoms, such as muscle aches and sluggishness. Dr. Tucci stressed that the medication did not have an adverse impact on kidney function, as evidenced by the fact that there was no significant change in the glomerular filtration rate (pretreatment average value = 64 mL/min, post-treatment average value = 68 mL/min). Two patients had asymptomatic hypocalcaemia, with serum calcium measurements of 8.0 mg/dL and 8.3 mg/dL, respectively. "The treatment was tolerable and demonstrated renal safety," noted Dr. Tucci. The mean age of patients in this study was 78 years old, and all subjects had proved refractory to prior bisphosphonate therapy, including pamidronate, alendronate, and risedronate. Funding for this study was provided by Novartis Pharmaceuticals Corporation. [Presentation title: Efficacy and Safety of Intravenous Zoledronic Acid in the Treatment of Patients With Paget's Disease of Bone. Abstract Sa479]
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