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
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Published in |
Osteoporosis International, June 2015
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DOI | 10.1007/s00198-015-3179-x |
Pubmed ID | |
Authors |
S. Ferrari, J. D. Adachi, K. Lippuner, C. Zapalowski, P. D. Miller, J.-Y. Reginster, O. Törring, D. L. Kendler, N. S. Daizadeh, A. Wang, C. D. O’Malley, R. B. Wagman, C. Libanati, E. M. Lewiecki |
Abstract |
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. This study aimed to evaluate whether denosumab treatment continued beyond 3 years is associated with a further reduction in nonvertebral fracture rates. Participants who completed the 3-year placebo-controlled 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. 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 long-term 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). 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. |
X Demographics
Geographical breakdown
Country | Count | As % |
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United States | 1 | 33% |
France | 1 | 33% |
Unknown | 1 | 33% |
Demographic breakdown
Type | Count | As % |
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Members of the public | 3 | 100% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
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Spain | 1 | 1% |
Unknown | 85 | 99% |
Demographic breakdown
Readers by professional status | Count | As % |
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Other | 12 | 14% |
Student > Bachelor | 11 | 13% |
Student > Master | 10 | 12% |
Professor > Associate Professor | 9 | 10% |
Researcher | 7 | 8% |
Other | 18 | 21% |
Unknown | 19 | 22% |
Readers by discipline | Count | As % |
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Medicine and Dentistry | 41 | 48% |
Biochemistry, Genetics and Molecular Biology | 5 | 6% |
Agricultural and Biological Sciences | 5 | 6% |
Nursing and Health Professions | 3 | 3% |
Pharmacology, Toxicology and Pharmaceutical Science | 2 | 2% |
Other | 5 | 6% |
Unknown | 25 | 29% |