caa a22 4500 357748344 20210129033014.0 cr unu---uuuuu 160304e201512 xx s 000 0 eng 0937-941X 10.1007/s00198-015-3234-7 doi (BORIS)oai:boris.unibe.ch:76342 610 ddc 26202488 pmid The effect of 8 or 5years of denosumab treatment in postmenopausal women with osteoporosis: results from the FREEDOM Extension study [Elektronische Daten] [S Papapoulos, Kurt Lippuner, C Roux, C J F Lin, D L Kendler, E M Lewiecki, M L Brandi, E Czerwiński, E Franek, P Lakatos, C Mautalen, S Minisola, J Y Reginster, S Jensen, N S Daizadeh, A Wang, M Gavin, C Libanati, R B Wagman, H G Bone] publishedVersion openAccess eu-repo UNLABELLED The FREEDOM study and its Extension provide long-term information about the effects of denosumab for the treatment of postmenopausal osteoporosis. Treatment for up to 8years was associated with persistent reduction of bone turnover, continued increases in bone mineral density, low fracture incidence, and a favorable benefit/risk profile. INTRODUCTION This study aims to report the results through year 5 of the FREEDOM Extension study, representing up to 8years of continued denosumab treatment in postmenopausal women with osteoporosis. METHODS Women who completed the 3-year FREEDOM study were eligible to enter the 7-year open-label FREEDOM Extension in which all participants are scheduled to receive denosumab, since placebo assignment was discontinued for ethical reasons. A total of 4550 women enrolled in the Extension (2343 long-term; 2207 cross-over). In this analysis, women in the long-term and cross-over groups received denosumab for up to 8 and 5years, respectively. RESULTS Throughout the Extension, sustained reduction of bone turnover markers (BTMs) was observed in both groups. In the long-term group, mean bone mineral density (BMD) continued to increase significantly at each time point measured, for cumulative 8-year gains of 18.4 and 8.3% at the lumbar spine and total hip, respectively. In the cross-over group, mean BMD increased significantly from the Extension baseline for 5-year cumulative gains of 13.1 and 6.2% at the lumbar spine and total hip, respectively. The yearly incidence of new vertebral and nonvertebral fractures remained low in both groups. The incidence of adverse and serious adverse events did not increase over time. Through Extension year 5, eight events of osteonecrosis of the jaw and two events of atypical femoral fracture were confirmed. CONCLUSIONS Denosumab treatment for up to 8years was associated with persistent reductions of BTMs, continued BMD gains, low fracture incidence, and a consistent safety profile. Papapoulos S. joint author Lippuner Kurt joint author Roux C. joint author Lin C J F. joint author Kendler D L. joint author Lewiecki E M. joint author Brandi M L. joint author Czerwiński E. joint author Franek E. joint author Lakatos P. joint author Mautalen C. joint author Minisola S. joint author Reginster J Y. joint author Jensen S. joint author Daizadeh N S. joint author Wang A. joint author Gavin M. joint author Libanati C. joint author Wagman R B. joint author Bone H G. joint author Osteoporosis international 26(12), pp. 2773-2783 0937-941X 12103254X http://boris.unibe.ch/76342/1/art%253A10.1007%252Fs00198-015-3234-7.pdf text/html WWW-Backlink auf das Repository BK010053 XK010053 XK010000 1 info:eu-repo/semantics/article boris PeerReviewed boris peerstatus BORIS BORIS BORIS info:eu-repo/semantics/article openAccess BORIS 856 40 http://boris.unibe.ch/76342/1/art%253A10.1007%252Fs00198-015-3234-7.pdf text/html WWW-Backlink auf das Repository BORIS 700 1- Papapoulos S. joint author BORIS 700 1- Lippuner Kurt joint author BORIS 700 1- Roux C. joint author BORIS 700 1- Lin C J F. joint author BORIS 700 1- Kendler D L. joint author BORIS 700 1- Lewiecki E M. joint author BORIS 700 1- Brandi M L. joint author BORIS 700 1- Czerwiński E. joint author BORIS 700 1- Franek E. joint author BORIS 700 1- Lakatos P. joint author BORIS 700 1- Mautalen C. joint author BORIS 700 1- Minisola S. joint author BORIS 700 1- Reginster J Y. joint author BORIS 700 1- Jensen S. joint author BORIS 700 1- Daizadeh N S. joint author BORIS 700 1- Wang A. joint author BORIS 700 1- Gavin M. joint author BORIS 700 1- Libanati C. joint author BORIS 700 1- Wagman R B. joint author BORIS 700 1- Bone H G. joint author BORIS 773 0- Osteoporosis international 26(12), pp. 2773-2783 0937-941X 12103254X SWISSBIB 357748344