Article (Scientific journals)
Further reductions in nonvertebral fracture rate with long-term denosumab treatment in the FREEDOM open-label extension and influence of hip bone mineral density after 3 years.
FERRARI, S.; ADACHI, J.D.; LUPPUNER, K. et al.
2015In Osteoporosis International, 26, p. 2763-2771
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Keywords :
denosumab; fracture treshold; hip bone mineral density; long-term osteoporosis therapy; nonvertebral fracture; treatment to goal
Abstract :
[en] Limited data exist on the efficacy of long-term therapies for osteoporosis. In osteoporotic postmenopausal women receiving denosumab for 7 years, nonvertebral fracture rates significantly decreased in years 4–7 versus years 1–3. This is the first demonstration of a further benefit on fracture outcomes with long-term therapy for osteoporosis. Introduction This study aimed to evaluate whether denosumab treatment continued beyond 3 years is associated with a further reduction in nonvertebral fracture rates. Methods Participants who completed the 3-year placebocontrolled Fracture REduction Evaluation of Denosumab in Osteoporosis every 6 Months (FREEDOM) study were invited to participate in an open-label extension. The present analysis includes 4,074 postmenopausal women with osteoporosis (n=2,343 long-term; n=1,731 cross-over) who enrolled in the extension, missed ≤1 dose during their first 3 years of denosumab treatment, and continued into the fourth year of treatment. Comparison of nonvertebral fracture rates during years 1–3 of denosumab with that of the fourth year and with the rate during years 4–7 was evaluated. Results For the combined group, the nonvertebral fracture rate per 100 participant-years was 2.15 for the first 3 years of denosumab treatment (referent) and 1.36 in the fourth year (rate ratio [RR]=0.64; 95 % confidence interval (CI)=0.48 to 0.85, p=0.003). Comparable findings were observed in the groups separately and when nonvertebral fracture rates during years 1–3 were compared to years 4–7 in the longterm group (RR=0.79; 95 % CI=0.62 to 1.00, p=0.046). Fracture rate reductions in year 4 were most prominent in subjects with persisting low hip bone mineral density (BMD). Conclusions Denosumab treatment beyond 3 years was associated with a further reduction in nonvertebral fracture rate that persisted through 7 years of continuous denosumab administration. The degree to which denosumab further reduces nonvertebral fracture risk appears influenced by the hip bone density achieved with initial therapy
Disciplines :
General & internal medicine
Author, co-author :
FERRARI, S.
ADACHI, J.D.
LUPPUNER, K.
ZAPALOWSKI, C.
MILLER, P.D.
Reginster, Jean-Yves  ;  Université de Liège > Département des sciences de la santé publique > Santé publique, Epidémiologie et Economie de la santé
TORRING, O.
KENDLER, D.L.
DAIZADEH, N.S.
WANG, A.
O'MALLEY, C.D.
WAGMAN, R.B.
LIBANATI, C.
LEWICKI, E.M.
More authors (4 more) Less
Language :
English
Title :
Further reductions in nonvertebral fracture rate with long-term denosumab treatment in the FREEDOM open-label extension and influence of hip bone mineral density after 3 years.
Publication date :
2015
Journal title :
Osteoporosis International
ISSN :
0937-941X
eISSN :
1433-2965
Publisher :
Springer Science & Business Media B.V., Godalming, United Kingdom
Volume :
26
Pages :
2763-2771
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 21 December 2015

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