The DOI matches its Crossref record; 6 of the 6 references it cites were found in a registry or an index.
The Effect of Three or Six Years of Denosumab Exposure in Women With Postmenopausal Osteoporosis: Results From the FREEDOM Extension
Open accessAbstract
CONTEXT: The Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months (FREEDOM) extension is evaluating the long-term efficacy and safety of denosumab for up to 10 years. OBJECTIVE: The objective of the study was to report results from the first 3 years of the extension, representing up to 6 years of denosumab exposure. DESIGN, SETTING, AND PARTICIPANTS: This was a multicenter, international, open-label study of 4550 women. INTERVENTION: Women from the FREEDOM denosumab group received 3 more years of denosumab for a total of 6 years (long-term) and women from the FREEDOM placebo group received 3 years of denosumab (crossover). MAIN OUTCOME MEASURES: Bone turnover markers (BTMs), bone mineral density (BMD), fracture, and safety data are reported. RESULTS: Reductions in BTMs were maintained (long-term) or achieved rapidly (crossover) after denosumab administration. In the long-term group, BMD further increased for cumulative 6-year gains of 15.2% (lumbar spine) and 7.5% (total hip). During the first 3 years of denosumab treatment, the crossover group had significant gains in lumbar spine (9.4%) and total hip (4.8%) BMD, similar to the long-term group during the 3-year FREEDOM trial. In the long-term group, fracture incidences remained low and below the rates projected for a virtual placebo cohort. In the crossover group, 3-year incidences of new vertebral and nonvertebral fractures were similar to those of the FREEDOM denosumab group. Incidence rates of adverse events did not increase over time. Six participants had events of osteonecrosis of the jaw confirmed by adjudication. One participant had a fracture adjudicated as consistent with atypical femoral fracture. CONCLUSION: Denosumab treatment for 6 years remained well tolerated, maintained reduced bone turnover, and continued to increase BMD. Fracture incidence remained low.
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Cites
Osteoclast differentiation and activation
Boyle, W. J., Simonet, W. S., & Lacey, D. L. (2003) · Nature · doi:10.1038/nature01658 · Cited by 6,670 · cited 1×
“Receptor activator of nuclear factor- B ligand (RANKL) plays an essential role in mediating bone resorption through osteoclast formation, function, and survival (1, 2).”
BackgroundDenosumab for Prevention of Fractures in Postmenopausal Women with Osteoporosis
Cummings, S. R., Martin, J. S., McClung, M. R., Siris, E. S., Eastell, R., Reid, I. R., Delmas, P., Zoog, H. B., Austin, M., Wang, A., et al. (2009) · New England Journal of Medicine · doi:10.1056/nejmoa0809493 · Cited by 3,489
Self-citationShane, E., Burr, D., Abrahamsen, B., Adler, R. A., Brown, T. D., Cheung, A. M., Cosman, F., Curtis, J. R., Dell, R., Dempster, D. W., et al. (2014) · Journal of Bone and Mineral Research · doi:10.1002/jbmr.1998 · Cited by 2,147
Self-citationTen Years' Experience with Alendronate for Osteoporosis in Postmenopausal Women
Bone, H. G., Hosking, D., Devogelaer, J.-P., Tucci, J. R., Emkey, R. D., Tonino, R. P., Rodriguez-Portales, J. A., Downs, R. W., Gupta, J., Santora, A. C., et al. (2004) · New England Journal of Medicine · doi:10.1056/nejmoa030897 · Cited by 1,347
Self-citationDenosumab in postmenopausal women with low bone mineral density.
McClung, M. R., Lewiecki, E. M., Cohen, S. B., Bolognese, M. A., Woodson, G. C., Moffett, A. H., Peacock, M., Miller, P. D., Lederman, S. N., Chesnut, C. H., et al. (2006) · New England Journal of Medicine · doi:10.1056/nejmoa044459 · Cited by 1,228
Osteoprotegerin and RANKL regulate bone resorption, density, geometry and strength.
KOSTENUIK, P. (2005) · Current Opinion in Pharmacology · doi:10.1016/j.coph.2005.06.005 · Cited by 281
Cited by
An overview and management of osteoporosis
Sözen, T., Özışık, L., & Çalık Başaran, N. (2019) · European Journal of Rheumatology · doi:10.5152/eurjrheum.2016.048 · Cited by 2,262
Camacho, P. M., Petak, S. M., Binkley, N., Diab, D. L., Eldeiry, L. S., Farooki, A., Harris, S. T., Hurley, D. L., Kelly, J., Lewiecki, E. M., et al. (2020) · Endocrine Practice · doi:10.4158/gl-2020-0524suppl · Cited by 1,182
Camacho, P. M., Petak, S. M., Binkley, N., Clarke, B. L., Harris, S. T., Hurley, D. L., Kleerekoper, M., Lewiecki, E. M., Miller, P. D., Narula, H. S., et al. (2016) · Endocrine Practice · doi:10.4158/ep161435.esgl · Cited by 1,140
Bone, H. G., Wagman, R. B., Brandi, M. L., Brown, J. P., Chapurlat, R., Cummings, S. R., Czerwiński, E., Fahrleitner-Pammer, A., Kendler, D. L., Lippuner, K., et al. (2017) · The Lancet Diabetes & Endocrinology · doi:10.1016/s2213-8587(17)30138-9 · Cited by 996
Self-citationEastell, R., Rosen, C. J., Black, D. M., Cheung, A. M., Murad, M. H., & Shoback, D. (2019) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jc.2019-00221 · Cited by 868
Metadata
- Authors
- Bone, H. G., Chapurlat, R., Brandi, M.-L., Brown, J. P., Czerwiński, E., Krieg, M.-A., Mellström, D., Radominski, S. C., Reginster, J.-Y., Resch, H., Ivorra, J. A. R., Roux, C., Vittinghoff, E., Daizadeh, N. S., Wang, A., Bradley, M. N., Franchimont, N., Geller, M. L., Wagman, R. B., Cummings, S. R., & Papapoulos, S.
- Venue
- The Journal of Clinical Endocrinology & Metabolism
- Publisher
- The Endocrine Society
- Published
- 2013-11
- Volume
- 98
- Issue
- 11
- Pages
- 4483-4492
- ISSN
- 0021-972X (ISSN-L)
- 1945-7197
- OpenAlex
- W2099385877
- Cited by
- 254
- References
- 6
- FWCI
- 33.87
- Type
- journal article
- Language
- en
- Open access
- hybrid
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- The paper
- Bone, H. G., Chapurlat, R., Brandi, M.-L., Brown, J. P., Czerwiński, E., Krieg, M.-A., Mellström, D., Radominski, S. C., Reginster, J.-Y., Resch, H., Ivorra, J. A. R., Roux, C., Vittinghoff, E., Daizadeh, N. S., Wang, A., Bradley, M. N., Franchimont, N., Geller, M. L., Wagman, R. B., . . . Papapoulos, S. (2013). The Effect of Three or Six Years of Denosumab Exposure in Women With Postmenopausal Osteoporosis: Results From the FREEDOM Extension. The Journal of Clinical Endocrinology & Metabolism. https://doi.org/10.1210/jc.2013-1597
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Bibliographic data: Semantic Scholar, OpenAlex, Crossref.
Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
