Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis
Open accessAbstract
BACKGROUND: Romosozumab is a monoclonal antibody that binds to and inhibits sclerostin, increases bone formation, and decreases bone resorption. METHODS: We enrolled 4093 postmenopausal women with osteoporosis and a fragility fracture and randomly assigned them in a 1:1 ratio to receive monthly subcutaneous romosozumab (210 mg) or weekly oral alendronate (70 mg) in a blinded fashion for 12 months, followed by open-label alendronate in both groups. The primary end points were the cumulative incidence of new vertebral fracture at 24 months and the cumulative incidence of clinical fracture (nonvertebral and symptomatic vertebral fracture) at the time of the primary analysis (after clinical fractures had been confirmed in ≥330 patients). Secondary end points included the incidences of nonvertebral and hip fracture at the time of the primary analysis. Serious cardiovascular adverse events, osteonecrosis of the jaw, and atypical femoral fractures were adjudicated. RESULTS: Over a period of 24 months, a 48% lower risk of new vertebral fractures was observed in the romosozumab-to-alendronate group (6.2% [127 of 2046 patients]) than in the alendronate-to-alendronate group (11.9% [243 of 2047 patients]) (P<0.001). Clinical fractures occurred in 198 of 2046 patients (9.7%) in the romosozumab-to-alendronate group versus 266 of 2047 patients (13.0%) in the alendronate-to-alendronate group, representing a 27% lower risk with romosozumab (P<0.001). The risk of nonvertebral fractures was lower by 19% in the romosozumab-to-alendronate group than in the alendronate-to-alendronate group (178 of 2046 patients [8.7%] vs. 217 of 2047 patients [10.6%]; P=0.04), and the risk of hip fracture was lower by 38% (41 of 2046 patients [2.0%] vs. 66 of 2047 patients [3.2%]; P=0.02). Overall adverse events and serious adverse events were balanced between the two groups. During year 1, positively adjudicated serious cardiovascular adverse events were observed more often with romosozumab than with alendronate (50 of 2040 patients [2.5%] vs. 38 of 2014 patients [1.9%]). During the open-label alendronate period, adjudicated events of osteonecrosis of the jaw (1 event each in the romosozumab-to-alendronate and alendronate-to-alendronate groups) and atypical femoral fracture (2 events and 4 events, respectively) were observed. CONCLUSIONS: In postmenopausal women with osteoporosis who were at high risk for fracture, romosozumab treatment for 12 months followed by alendronate resulted in a significantly lower risk of fracture than alendronate alone. (Funded by Amgen and others; ARCH ClinicalTrials.gov number, NCT01631214 .).
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In the ARCH study, major cardiac events were observed; headaches, arthralgia, and injection site reactions were also observed.
“However, major cardiac events were observed in the ARCH study, while headaches, arthralgia, and injection site reactions were also observed [89,90].”
From Osteoporosis: Molecular Pathology, Diagnostics, and Therapeutics (2023) · cites this paper as [89]
The Safety section reports serious cardiovascular events and injection-site reactions in the ARCH trial. The available passages do not report headache or arthralgia as observed adverse events; a table footnote lists arthritis-related conditions, but not arthralgia. Page numbers were not available in our copy. (LLM, conf=0.84)
Experimental — accuracy not yet measuredAs of 2021, romosozumab has reached Phase III trials, which have shown an increase in bone mineral density and a decrease in vertebral and hip fractures.
“As of 2021, it has reached Phase III trials, which have shown an increase in bone mineral density and a decrease in vertebral and hip fractures.”
From Osteoporosis: Molecular Pathology, Diagnostics, and Therapeutics (2023) · cites this paper as [89]
In the ARCH study, the group that received romosozumab and alendronate had a 48% lower risk of new vertebral fractures than the alendronate-only group.
“The ARCH study showed a 48% lower risk of new vertebral fractures in the group that received romosozumab and alendronate than in the alendronate-only group [89].”
From Osteoporosis: Molecular Pathology, Diagnostics, and Therapeutics (2023) · cites this paper as [89]
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- Authors
- Saag, K. G., Petersen, J., Brandi, M. L., Karaplis, A. C., Lorentzon, M., Thomas, T., Maddox, J., Fan, M., Meisner, P. D., & Grauer, A.
- Affiliations
- Inserm (FR)
- Amgen (United States) (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2017-10-12
- Volume
- 377
- Issue
- 15
- Pages
- 1417-1427
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2754720807
- Cited by
- 1,544
- References
- 31
- Citations by year
- 2026: 204 · 2025: 216 · 2024: 210 · 2023: 148 · 2022: 179 · 2021: 172 · 2020: 185 · 2019: 114 · 2018: 94 · 2017: 19 · 2016: 1 · 2015: 1
- FWCI
- 123.81
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Florence Research (University of Florence) (submittedVersion, other-oa)
- Research Bank (Australian Catholic University) (submittedVersion)
- Funders
- Amgen
- Bristol-Myers Squibb
- Eli Lilly and Company
- Pfizer
- Gilead Sciences
- Teva Pharmaceutical Industries
- Radius Health
- Medac
- Chugai Pharmaceutical
- Amgen Canada
- UCB Pharma
- Topics
- Health Sciences › Medicine › Orthopedics and Sports Medicine › Bone health and osteoporosis research
- Health Sciences › Medicine › Oncology › Bone health and treatments
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Menopause: Health Impacts and Treatments
- Keywords
- romosozumab, alendronate, osteoporosis, fracture prevention, sclerostin inhibition, postmenopausal women, vertebral fractures, hip fracture, non-vertebral fractures, bisphosphonates, cardiovascular adverse events, osteonecrosis of the jaw, atypical femoral fractures, bone formation, bone resorption, fragility fractures, open-label extension
- MeSH terms
- Aged, Antibodies, Monoclonal, Cardiovascular Diseases, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Risk, Bone Density, Osteoporosis, Postmenopausal, Incidence, Least-Squares Analysis, Spinal Fractures, Bone Remodeling, Alendronate, Bone Density Conservation Agents, Fractures, Bone
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