Abstract
Introduction: Once-yearly i.v. infusion of zoledronic acid 5 mg (ZOL) is an effective and well-tolerated treatment for osteoporosis. ZOL has shown improved compliance compared with daily and weekly oral bisphosphonates. The primary objective of this study was to assess serum Ntelopeptide (NTx) area under the curve (AUC) of ZOL vs. oral alendronate (ALN). Secondary objectives were evaluation of serum N-terminal propeptide of type-1 collagen(P1NP) AUC, serum P1NP and NTx at different timepoints, compliance, quality of life, patient preference assessment and safety. Methods: The Rapid Onset and Sustained Efficacy (ROSE) study was a 1-year, open-label, multicentre, randomized, controlled trial in 594 postmenopausal women aged 55-99 years, with documented osteopenia/ osteoporosis. Patients were randomized (2:1) to receive either once-yearly i.v. ZOL or once-weekly oral ALN. All patients received daily calcium 1200 mg and vitamin D 800 I.U. Discussion: Baseline characteristics were balanced between treatment groups. An analysis of the preliminary data available to date showed that ZOL has a greater and more rapid reduction of serum NTx compared with ALN. The NTx nadir level was reached at 3 months with ZOL vs. 9 months with ALN. At Month 12, NTx levels were still slightly suppressed but significantly higher in the ZOL group compared with the ALN group (P=0.013) (Figure 1). Conclusion: In the 1-year ROSE study, there was greater and more rapid reduction of serum NTx with once-yearly i.v. ZOL compared with once-weekly oral ALN.(Figure presented).