ECE2007 Oral Communications Bone & calcium metabolism (7 abstracts)
Effect of once-yearly infusion of zoledronic acid 5 mg in postmenopausal women with osteoporosis
Richard Eastell 1 , Peter Lakatos 2 , Dennis Black 3 , Steven Boonen 4 , Felicia Cosman 5 , Steven Cumings 3 , Pierre Delmas 6 , Erik Fink Eriksen 7 , Ping Chung Leung 8 , Zulema Man 9 , Peter Mesenbrink 10 , Ian Reid 11 & Jane Cauley 12
1University of Sheffield, Sheffield, United Kingdom; 2Semmelweis University, Budapest, Hungary; 3University of California, San Francisco, San Francisco, CA, United States; 4Leuven University Center for Metabolic Bone Diseases, Leuven, Belgium; 5Helen Hayes Hospital, West Haverstraw, NY, United States; 6INSERM Unit 403, Hopital Edouard Herriot, Lyon, France; 7Novartis Pharma AG, Basel, Switzerland; 8The Chinese University of Hong Kong, Hong Kong, China; 9Centro TIEMPO, Buenos Aires, Argentina; 10Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States; 11University of Auckland, Auckland, New Zealand; 12University of Pittsburgh, Pittsburgh, PA, United States.
Background and methods: The HORIZON-PFT is a multinational, 3-year, randomized, double-blind, placebo-controlled trial evaluating the potential of once-yearly zoledronic acid (ZOL) 5 mg, infused over 15 minutes, to decrease risk of fracture in 7736 postmenopausal osteoporotic women 65–89 years of age.
Results: Treatment with ZOL 5 mg resulted in significant relative risk reductions in morphometric vertebral fracture of 70% vs PBO (3.8% vs 12.8%; 95% CI [62%, 76%]) and in hip fracture of 41% vs PBO (1.4% vs 2.5%; 95% CI [17%, 58%]). Secondary endpoints, non-vertebral (excluding finger, toe, and facial), clinical vertebral, and any clinical fracture (including non-vertebral, hip, and clinical vertebral), were significantly reduced by 25%, 77%, and 33% (all P<.0001), respectively. Bone mineral density increased significantly in ZOL vs PBO at total hip (6.0%), lumbar spine (6.9%), and femoral neck (5.0%) (P<.0001). While transient increases in serum creatinine≥0.5 mg/dl over pre-infusion levels were seen in a small fraction (1.3%) of patients in the ZOL 5 mg group, no cumulative impact on renal function was demonstrable. Hypocalcemia (serum calcium<2.075 mmol/l) was observed in 2.3% of patients. Virtually all events occurred after the first infusion of ZOL and all were asymptomatic and transient. Adverse events occurring≤3 days after infusion were more frequent after first infusion (44.7% ZOL vs 14.7% PBO) but declined markedly on subsequent infusions. There were more atrial fibrillation serious adverse events in ZOL vs PBO (1.3% vs 0.5%). Two cases of osteonecrosis of the jaw (1 in PBO, 1 in ZOL) were identified on adjudication; both resolved with antibiotic therapy and limited debridement.
Conclusion: Once-yearly infusion of ZOL 5 mg over 3 years achieves a highly significant decrease in vertebral, hip, and other fracture risk and is generally safe and well tolerated.
Volume 14
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