The DOI matches its Crossref record; 5 of the 5 references it cites were found in a registry or an index.
A Phase III Randomized Placebo-Controlled Trial to Evaluate Efficacy and Safety of Romosozumab in Men With Osteoporosis
Open accessAbstract
Context: Globally, one in five men aged >50 years is predicted to experience an osteoporotic fracture. Because of the treatment gap in osteoporosis and the paucity of bone-forming agents for men, new osteoporosis treatments are needed. Objective: To evaluate the safety and efficacy of romosozumab in men with osteoporosis. Design: Phase III randomized BRIDGE study (placebo-controlled double-blind study evaluating the efficacy and safety of romosozumab in treating men with osteoporosis; ClinicalTrials.gov identifier, NCT02186171) for 12 months. Setting: Thirty-one centers in Europe, Latin America, Japan, and North America. Patients: Men aged 55 to 90 years with a baseline bone mineral density (BMD) T-score at the lumbar spine (LS), total hip (TH), or femoral neck of ≤-2.5 or ≤-1.5 with a history of a fragility nonvertebral or vertebral fracture. Interventions: The subjects were randomized 2:1 to receive romosozumab 210 mg subcutaneously monthly or placebo for 12 months. Main Outcome Measures: The primary efficacy endpoint was percentage change from baseline in LS BMD at month 12. Results: In 245 subjects (163 romosozumab, 82 placebo), at month 12, the mean percentage change from baseline in the LS and TH BMD was significantly greater for the romosozumab group than for the placebo group (LS, 12.1% vs 1.2%; TH, 2.5% vs -0.5%; P < 0.001). Adverse events and serious adverse events were balanced between the two groups, with a numerical imbalance in the positively adjudicated cardiovascular serious adverse events [romosozumab, 8 (4.9%) vs placebo, 2 (2.5%)]. Conclusions: Treatment with romosozumab for 12 months increased the spine and hip BMD compared with placebo and was well tolerated in men with osteoporosis.
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Cites
Dempster, D. W., Compston, J. E., Drezner, M. K., Glorieux, F. H., Kanis, J. A., Malluche, H., Meunier, P. J., Ott, S. M., Recker, R. R., & Parfitt, A. M. (2013) · Journal of Bone and Mineral Research · doi:10.1002/jbmr.1805 · Cited by 2,543
Zoledronic Acid and Clinical Fractures and Mortality after Hip Fracture
Lyles, K. W., Colón-Emeric, C. S., Magaziner, J. S., Adachi, J. D., Pieper, C. F., Mautalen, C., Hyldstrup, L., Recknor, C., Nordsletten, L., Moore, K. A., et al. (2007) · New England Journal of Medicine · doi:10.1056/nejmoa074941 · Cited by 2,003
Romosozumab Treatment in Postmenopausal Women with Osteoporosis
Cosman, F., Crittenden, D. B., Adachi, J. D., Binkley, N., Czerwinski, E., Ferrari, S., Hofbauer, L. C., Lau, E., Lewiecki, E. M., Miyauchi, A., et al. (2016) · New England Journal of Medicine · doi:10.1056/nejmoa1607948 · Cited by 1,805
Self-citationRomosozumab in Postmenopausal Women with Low Bone Mineral Density
McClung, M. R., Grauer, A., Boonen, S., Bolognese, M. A., Brown, J. P., Diez-Perez, A., Langdahl, B. L., Reginster, J.-Y., Zanchetta, J. R., Wasserman, S. M., et al. (2014) · New England Journal of Medicine · doi:10.1056/nejmoa1305224 · Cited by 1,258
Self-citationFracture risk and zoledronic acid therapy in men with osteoporosis
Boonen, S., Reginster, J.-Y., Kaufman, J.-M., Lippuner, K., Zanchetta, J., Langdahl, B., Rizzoli, R., Lipschitz, S., Dimai, H. P., Witvrouw, R., et al. (2012) · New England Journal of Medicine · doi:10.1056/nejmoa1204061 · Cited by 359
Cited by
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
Self-citationWnt/β-catenin signaling components and mechanisms in bone formation, homeostasis, and disease
Hu, L., Chen, W., Qian, A., & Li, Y.-P. (2024) · Bone Research · doi:10.1038/s41413-024-00342-8 · Cited by 359
Long-term and sequential treatment for osteoporosis
Foessl, I., Dimai, H. P., & Obermayer-Pietsch, B. (2023) · Nature Reviews Endocrinology · doi:10.1038/s41574-023-00866-9 · Cited by 273
Vlashi, R., Zhang, X., Wu, M., & Chen, G. (2023) · Genes & Diseases · doi:10.1016/j.gendis.2022.07.011 · Cited by 165
Bovijn, J., Krebs, K., Chen, C.-Y., Boxall, R., Censin, J. C., Ferreira, T., Pulit, S. L., Glastonbury, C. A., Laber, S., Millwood, I. Y., et al. (2020) · Science Translational Medicine · doi:10.1126/scitranslmed.aay6570 · Cited by 119
Metadata
- Authors
- Lewiecki, E. M., Blicharski, T., Goemaere, S., Lippuner, K., Meisner, P. D., Miller, P. D., Miyauchi, A., Maddox, J., Chen, L., & Horlait, S.
- Venue
- The Journal of Clinical Endocrinology & Metabolism
- Publisher
- The Endocrine Society
- Published
- 2018-06-20
- Volume
- 103
- Issue
- 9
- Pages
- 3183-3193
- ISSN
- 0021-972X (ISSN-L)
- 1945-7197
- OpenAlex
- W2808994945
- Cited by
- 328
- References
- 5
- FWCI
- 28.69
- Type
- journal article
- Language
- en
- Open access
- bronze
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- Lewiecki, E. M., Blicharski, T., Goemaere, S., Lippuner, K., Meisner, P. D., Miller, P. D., Miyauchi, A., Maddox, J., Chen, L., & Horlait, S. (2018). A Phase III Randomized Placebo-Controlled Trial to Evaluate Efficacy and Safety of Romosozumab in Men With Osteoporosis. The Journal of Clinical Endocrinology & Metabolism. https://doi.org/10.1210/jc.2017-02163
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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.
