The DOI matches its Crossref record; 5 of the 5 references it cites were found in a registry or an index.
Five years of denosumab exposure in women with postmenopausal osteoporosis: Results from the first two years of the FREEDOM extension
Open accessAbstract
The 3-year FREEDOM trial assessed the efficacy and safety of 60 mg denosumab every 6 months for the treatment of postmenopausal women with osteoporosis. Participants who completed the FREEDOM trial were eligible to enter an extension to continue the evaluation of denosumab efficacy and safety for up to 10 years. For the extension results presented here, women from the FREEDOM denosumab group had 2 more years of denosumab treatment (long-term group) and those from the FREEDOM placebo group had 2 years of denosumab exposure (cross-over group). We report results for bone turnover markers (BTMs), bone mineral density (BMD), fracture rates, and safety. A total of 4550 women enrolled in the extension (2343 long-term; 2207 cross-over). Reductions in BTMs were maintained (long-term group) or occurred rapidly (cross-over group) following denosumab administration. In the long-term group, lumbar spine and total hip BMD increased further, resulting in 5-year gains of 13.7% and 7.0%, respectively. In the cross-over group, BMD increased at the lumbar spine (7.7%) and total hip (4.0%) during the 2-year denosumab treatment. Yearly fracture incidences for both groups were below rates observed in the FREEDOM placebo group and below rates projected for a “virtual untreated twin” cohort. Adverse events did not increase with long-term denosumab administration. Two adverse events in the cross-over group were adjudicated as consistent with osteonecrosis of the jaw. Five-year denosumab treatment of women with postmenopausal osteoporosis maintained BTM reduction and increased BMD, and was associated with low fracture rates and a favorable risk/benefit profile. © 2012 American Society for Bone and Mineral Research
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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 2×
“Receptor activator of NF-kB (RANK) ligand plays an essential role in mediating resorption through osteoclast formation, function, and survival.((1,2)) Denosumab is a fully human monoclonal antibody that inhibits RANK ligand.”
BackgroundSmall sample inference for fixed effects from restricted maximum likelihood
Kenward, M. G., & Roger, J. H. (1997) · Biometrics · doi:10.2307/2533558 · Cited by 4,552 · cited 1×
“Kenward and Roger’s approach((8)) was followed for estimating the denominator degrees of freedom for the hypothesis test.”
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-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-citationOsteoprotegerin 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
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Liu, D., Ahmet, A., Ward, L., Krishnamoorthy, P., Mandelcorn, E. D., Leigh, R., Brown, J. P., Cohen, A., & Kim, H. (2013) · Allergy, Asthma & Clinical Immunology · doi:10.1186/1710-1492-9-30 · Cited by 1,268
Self-citationBone, 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-citationMcClung, M. R., O'Donoghue, M. L., Papapoulos, S. E., Bone, H., Langdahl, B., Saag, K. G., Reid, I. R., Kiel, D. P., Cavallari, I., Bonaca, M. P., et al. (2019) · The Lancet Diabetes & Endocrinology · doi:10.1016/s2213-8587(19)30346-8 · Cited by 169
Self-citationChen, X., Zhi, X., Wang, J., & Su, J. (2018) · Bone Research · doi:10.1038/s41413-018-0035-6 · Cited by 154
Jobke, B., Milovanovic, P., Amling, M., & Busse, B. (2014) · Bone · doi:10.1016/j.bone.2013.10.024 · Cited by 123
Unexpected Bone Formation Produced by RANKL Blockade
Portal-Núñez, S., Mediero, A., Esbrit, P., Sánchez-Pernaute, O., Largo, R., & Herrero-Beaumont, G. (2017) · Trends in Endocrinology & Metabolism · doi:10.1016/j.tem.2017.06.003 · Cited by 32
Reginster, J. Y., Neuprez, A., Beaudart, C., Lecart, M. P., Sarlet, N., Bernard, D., Disteche, S., & Bruyere, O. (2014) · Drugs & Aging · doi:10.1007/s40266-014-0179-z · Cited by 29
Self-citationNew insight into unexpected bone formation by denosumab
Wang, L., Huang, B., Chen, X., & Su, J. (2020) · Drug Discovery Today · doi:10.1016/j.drudis.2020.09.001 · Cited by 13
Metadata
- Authors
- Papapoulos, S., Chapurlat, R., Libanati, C., Brandi, M. L., Brown, J. P., Czerwiński, E., Krieg, M.-A., Man, Z., Mellström, D., Radominski, S. C., Reginster, J.-Y., Resch, H., Ivorra, J. A. R., Roux, C., Vittinghoff, E., Austin, M., Daizadeh, N., Bradley, M. N., Grauer, A., Cummings, S. R., & Bone, H. G.
- Venue
- Journal of Bone and Mineral Research
- Publisher
- Oxford University Press (OUP)
- Published
- 2011-11-23
- Volume
- 27
- Issue
- 3
- Pages
- 694-701
- ISSN
- 0884-0431 (ISSN-L)
- 1523-4681
- OpenAlex
- W2087574295
- Cited by
- 344
- References
- 5
- FWCI
- 35.16
- Type
- journal article
- Language
- en
- Open access
- bronze
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