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Romosozumab Treatment in Postmenopausal Women with Osteoporosis
Open accessAbstract
BACKGROUND: Romosozumab, a monoclonal antibody that binds sclerostin, increases bone formation and decreases bone resorption. METHODS: We enrolled 7180 postmenopausal women who had a T score of -2.5 to -3.5 at the total hip or femoral neck. Patients were randomly assigned to receive subcutaneous injections of romosozumab (at a dose of 210 mg) or placebo monthly for 12 months; thereafter, patients in each group received denosumab for 12 months, at a dose of 60 mg, administered subcutaneously every 6 months. The coprimary end points were the cumulative incidences of new vertebral fractures at 12 months and 24 months. Secondary end points included clinical (a composite of nonvertebral and symptomatic vertebral) and nonvertebral fractures. RESULTS: At 12 months, new vertebral fractures had occurred in 16 of 3321 patients (0.5%) in the romosozumab group, as compared with 59 of 3322 (1.8%) in the placebo group (representing a 73% lower risk with romosozumab; P<0.001). Clinical fractures had occurred in 58 of 3589 patients (1.6%) in the romosozumab group, as compared with 90 of 3591 (2.5%) in the placebo group (a 36% lower risk with romosozumab; P=0.008). Nonvertebral fractures had occurred in 56 of 3589 patients (1.6%) in the romosozumab group and in 75 of 3591 (2.1%) in the placebo group (P=0.10). At 24 months, the rates of vertebral fractures were significantly lower in the romosozumab group than in the placebo group after each group made the transition to denosumab (0.6% [21 of 3325 patients] in the romosozumab group vs. 2.5% [84 of 3327] in the placebo group, a 75% lower risk with romosozumab; P<0.001). Adverse events, including instances of hyperostosis, cardiovascular events, osteoarthritis, and cancer, appeared to be balanced between the groups. One atypical femoral fracture and two cases of osteonecrosis of the jaw were observed in the romosozumab group. CONCLUSIONS: In postmenopausal women with osteoporosis, romosozumab was associated with a lower risk of vertebral fracture than placebo at 12 months and, after the transition to denosumab, at 24 months. The lower risk of clinical fracture that was seen with romosozumab was evident at 1 year. (Funded by Amgen and UCB Pharma; FRAME ClinicalTrials.gov number, NCT01575834 .).
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“It achieves this by upregulating the Wnt pathway while also acting as an enhancer of RANKL synthesis, thereby downregulating this latter pathway [83,84,85].”
From Osteoporosis: Molecular Pathology, Diagnostics, and Therapeutics (2023) · cites this paper as [83]
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“it uniquely exhibits the ability to stimulate bone formation while simultaneously reducing bone resorption.”
From Osteoporosis: Molecular Pathology, Diagnostics, and Therapeutics (2023) · cites this paper as [83]
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“Romosozumab is a newly approved monoclonal antibody targeting sclerostin.”
From Osteoporosis: Molecular Pathology, Diagnostics, and Therapeutics (2023) · cites this paper as [83]
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Citations
Cites
Osteoporosis Prevention, Diagnosis, and Therapy
NIH Consensus Development Panel on Osteoporosis Prevention, D. (2001) · JAMA: The Journal of the American Medical Association · doi:10.1001/jama.285.6.785 · Cited by 5,529
Epidemiology and outcomes of osteoporotic fractures
Cummings, S. R., & Melton, L. J. (2002) · The Lancet · doi:10.1016/s0140-6736(02)08657-9 · Cited by 3,821
Vertebral fracture assessment using a semiquantitative technique
Genant, H. K., Wu, C. Y., van Kuijk, C., & Nevitt, M. C. (1993) · Journal of Bone and Mineral Research · doi:10.1002/jbmr.5650080915 · Cited by 3,691
A systematic review of hip fracture incidence and probability of fracture worldwide
Kanis, J. A., Odén, A., McCloskey, E. V., Johansson, H., Wahl, D. A., Cooper, C. C., & on behalf of the IOF Working Group on Epidemiology and Quality of Life (2012) · Osteoporosis International · doi:10.1007/s00198-012-1964-3 · Cited by 1,382
Sclerostin Binds to LRP5/6 and Antagonizes Canonical Wnt Signaling
Li, X., Zhang, Y., Kang, H., Liu, W., Liu, P., Zhang, J., Harris, S. E., & Wu, D. (2005) · Journal of Biological Chemistry · doi:10.1074/jbc.m413274200 · Cited by 1,366
Romosozumab 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-citationIncreased bone density in sclerosteosis is due to the deficiency of a novel secreted protein (SOST)
Balemans, W. (2001) · Human Molecular Genetics · doi:10.1093/hmg/10.5.537 · Cited by 1,147
Brunkow, M. E., Gardner, J. C., Van Ness, J., Paeper, B. W., Kovacevich, B. R., Proll, S., Skonier, J. E., Zhao, L., Sabo, P. J., Fu, Y.-H., et al. (2001) · The American Journal of Human Genetics · doi:10.1086/318811 · Cited by 1,011
Sclerostin is a delayed secreted product of osteocytes that inhibits bone formation
Poole, K. E. S., Van Bezooijen, R. L., Loveridge, N., Hamersma, H., Papapoulos, S. E., Löwik, C. W., & Reeve, J. (2005) · The FASEB Journal · doi:10.1096/fj.05-4221fje · Cited by 965
Estimating Hip Fracture Morbidity, Mortality and Costs
Braithwaite, R. S., Col, N. F., & Wong, J. B. (2003) · Journal of the American Geriatrics Society · doi:10.1046/j.1532-5415.2003.51110.x · Cited by 915
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Wnt/β-Catenin Signaling, Disease, and Emerging Therapeutic Modalities
Nusse, R., & Clevers, H. (2017) · Cell · doi:10.1016/j.cell.2017.05.016 · Cited by 4,342
Compston, J. E., McClung, M. R., & Leslie, W. D. (2019) · The Lancet · doi:10.1016/s0140-6736(18)32112-3 · Cited by 2,449
Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis
Saag, K. G., Petersen, J., Brandi, M. L., Karaplis, A. C., Lorentzon, M., Thomas, T., Maddox, J., Fan, M., Meisner, P. D., & Grauer, A. (2017) · New England Journal of Medicine · doi:10.1056/nejmoa1708322 · Cited by 1,544
Self-citationThe clinician's guide to prevention and treatment of osteoporosis
LeBoff, M. S., Greenspan, S. L., Insogna, K. L., Lewiecki, E. M., Saag, K. G., Singer, A. J., & Siris, E. S. (2022) · Osteoporosis International · doi:10.1007/s00198-021-05900-y · Cited by 1,487
Self-citationCamacho, 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
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Metadata
- Authors
- Cosman, F., Crittenden, D. B., Adachi, J. D., Binkley, N., Czerwinski, E., Ferrari, S., Hofbauer, L. C., Lau, E., Lewiecki, E. M., Miyauchi, A., Zerbini, C. A. F., Milmont, C. E., Chen, L., Maddox, J., Meisner, P. D., Libanati, C., & Grauer, A.
- Affiliations
- Amgen (United States) (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2016-10-20
- Volume
- 375
- Issue
- 16
- Pages
- 1532-1543
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2520995084
- Cited by
- 1,805
- References
- 24
- Citations by year
- 2026: 225 · 2025: 223 · 2024: 219 · 2023: 168 · 2022: 194 · 2021: 192 · 2020: 182 · 2019: 141 · 2018: 131 · 2017: 110 · 2016: 16
- FWCI
- 161.53
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Archive ouverte UNIGE (University of Geneva) (publishedVersion, other-oa)
- IRIS (submittedVersion)
- SERVAL (Université de Lausanne) (submittedVersion)
- Archive ouverte UNIGE (University of Geneva) (submittedVersion, cc-by)
- Topics
- Health Sciences › Medicine › Orthopedics and Sports Medicine › Bone health and osteoporosis research
- Health Sciences › Medicine › Oncology › Bone health and treatments
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Bone Metabolism and Diseases
- Keywords
- romosozumab, sclerostin, osteoporosis, postmenopausal women, vertebral fractures, non-vertebral fractures, denosumab, bone formation, bone resorption, fracture risk reduction, monoclonal antibodies, adverse events, hyperostosis, cardiovascular events, osteoarthritis, cancer risk, RANKL
- MeSH terms
- Denosumab, Aged, Aged, 80 and over, Antibodies, Monoclonal, Double-Blind Method, Female, Humans, Injections, Subcutaneous, Middle Aged, Biomarkers, Bone Density, Osteoporosis, Postmenopausal, Spinal Fractures, Bone Remodeling, Bone Density Conservation Agents
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