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Zoledronic acid efficacy and safety over five years in postmenopausal osteoporosis

Devogelaer, J. P.; Brown, J. P.; Burckhardt, P.; Meunier, P. J.; Goemaere, S.; Lippuner, K.; Body, J. J.; Samsioe, Göran LU ; Felsenberg, D. and Fashola, T., et al. (2007) In Osteoporosis International 18(9). p.1211-1218
Abstract
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... (More)
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. (Less)
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publication status
published
subject
keywords
osteoporosis, osteopenia, bone mineral density, bone turnover, zoledronic acid
in
Osteoporosis International
volume
18
issue
9
pages
1211 - 1218
publisher
Springer
external identifiers
  • wos:000249900000008
  • scopus:34548127781
ISSN
1433-2965
DOI
10.1007/s00198-007-0367-3
language
English
LU publication?
yes
id
3a07c91d-e266-4c50-aba1-b0312aded739 (old id 655619)
date added to LUP
2007-12-07 11:52:07
date last changed
2017-04-09 04:20:32
@article{3a07c91d-e266-4c50-aba1-b0312aded739,
  abstract     = {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 (&lt; 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.},
  author       = {Devogelaer, J. P. and Brown, J. P. and Burckhardt, P. and Meunier, P. J. and Goemaere, S. and Lippuner, K. and Body, J. J. and Samsioe, Göran and Felsenberg, D. and Fashola, T. and Sanna, L. and Ortmann, C. E. and Trechsel, U. and Krasnow, J. and Eriksen, E. F. and Garnero, P.},
  issn         = {1433-2965},
  keyword      = {osteoporosis,osteopenia,bone mineral density,bone turnover,zoledronic acid},
  language     = {eng},
  number       = {9},
  pages        = {1211--1218},
  publisher    = {Springer},
  series       = {Osteoporosis International},
  title        = {Zoledronic acid efficacy and safety over five years in postmenopausal osteoporosis},
  url          = {http://dx.doi.org/10.1007/s00198-007-0367-3},
  volume       = {18},
  year         = {2007},
}