Zoledronic acid efficacy and safety over five years in postmenopausal osteoporosis
| Autor: | Patrick Garnero, Jacques P. Brown, T. Fashola, Ulrich Trechsel, Stefan Goemaere, Dieter Felsenberg, Jean-Pierre Devogelaer, Peter Burckhardt, C. E. Ortmann, Jean-Jacques Body, Erik Fink Eriksen, Joel S. Krasnow, Kurt Lippuner, Liuska Sanna, Pierre J. Meunier, Göran Samsioe |
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| Rok vydání: | 2006 |
| Předmět: |
Adult
medicine.medical_specialty Endocrinology Diabetes and Metabolism Osteoporosis Urology Zoledronic Acid Bone remodeling law.invention Fractures Bone Randomized controlled trial Double-Blind Method law Internal medicine Medicine Humans Osteoporosis Postmenopausal Bone Density Conservation Agents Diphosphonates business.industry Imidazoles Middle Aged medicine.disease Rheumatology Osteopenia Zoledronic acid Endocrinology Treatment Outcome Toxicity Orthopedic surgery Female business medicine.drug |
| Zdroj: | Devogelaer, J P; Brown, J P; Burckhardt, P; Meunier, P J; Goemaere, S; Lippuner, K; Body, J J; Samsioe, G; Felsenberg, D; Fashola, T; Sanna, L; Ortmann, C E; Trechsel, U; Krasnow, J; Eriksen, E F; Garnero, P (2007). Zoledronic acid efficacy and safety over five years in postmenopausal osteoporosis. Osteoporosis international, 18(9), pp. 1211-8. London: Springer 10.1007/s00198-007-0367-3 |
| ISSN: | 0937-941X |
| DOI: | 10.1007/s00198-007-0367-3 |
| Popis: | In a 5-year study involving 119 postmenopausal women, zoledronic acid 4 mg given once-yearly for 2, 3 or 5 years was well tolerated with no evidence of excessive bone turnover reduction or any safety signals. BMD increased significantly. Bone turnover markers decreased from baseline and were maintained within premenopausal reference ranges. INTRODUCTION: After completion of the core study, two consecutive, 2-year, open-label extensions investigated the efficacy and safety of zoledronic acid 4 mg over 5 years in postmenopausal osteoporosis. METHODS: In the core study, patients received 1 to 4 mg zoledronic acid or placebo. In the first extension, most patients received 4 mg per year and then patients entered the second extension and received 4 mg per year or calcium only. Patients were divided into three subgroups according to years of active treatment received (2, 3 or 5 years). Changes in BMD and bone turnover markers (bone ALP and CTX-I) were assessed. RESULTS: All subgroups showed substantial increases in BMD and decreases in bone markers. By the end of the core study, 37.5% of patients revealed a suboptimal reduction (< 30%) of bone ALP levels. After subsequent study drug administration during the extensions, there was no evidence of progressive reduction of bone turnover markers. Furthermore, increased marker levels after treatment discontinuation demonstrates preservation of bone remodelling capacity. CONCLUSIONS: This study showed that zoledronic acid 4 mg once-yearly was well tolerated and effective in reducing biomarkers over 5 years. Detailed analysis of bone marker changes, however, suggests that this drug regimen causes insufficient reduction of remodelling activity in one third of patients. |
| Databáze: | OpenAIRE |
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