Cited by 1,805Bone health and osteoporosis researchBone health and treatmentsBone Metabolism and Diseases

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Romosozumab Treatment in Postmenopausal Women with Osteoporosis

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Cosman, Felicia, Crittenden, Daria B., Adachi, Jonathan D., Binkley, Neil, Czerwinski, Edward, Ferrari, Serge, Hofbauer, Lorenz C., Lau, Edith, Lewiecki, E. Michael, Miyauchi, Akimitsu, Zerbini, Cristiano A.F., Milmont, Cassandra E., Chen, Li, Maddox, Judy, Meisner, Paul D., Libanati, Cesar, Grauer, Andreas·2016·New England Journal of Medicine

DOI 10.1056/nejmoa1607948

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Abstract

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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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: Cosman, Felicia
Crittenden, Daria B.
Adachi, Jonathan D.
Binkley, Neil
Czerwinski, Edward
Ferrari, Serge
Hofbauer, Lorenz C.
Lewiecki, E. Michael
Zerbini, Cristiano A.F.
Chen, Li
Maddox, Judy
Libanati, Cesar
Grauer, Andreas
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
DOI: 10.1056/nejmoa1607948
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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Romosozumab Treatment in Postmenopausal Women with Osteoporosis

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