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Denosumab for Prevention of Fractures in Postmenopausal Women with Osteoporosis
Open accessAbstract
BACKGROUND: Denosumab is a fully human monoclonal antibody to the receptor activator of nuclear factor-kappaB ligand (RANKL) that blocks its binding to RANK, inhibiting the development and activity of osteoclasts, decreasing bone resorption, and increasing bone density. Given its unique actions, denosumab may be useful in the treatment of osteoporosis. METHODS: We enrolled 7868 women between the ages of 60 and 90 years who had a bone mineral density T score of less than -2.5 but not less than -4.0 at the lumbar spine or total hip. Subjects were randomly assigned to receive either 60 mg of denosumab or placebo subcutaneously every 6 months for 36 months. The primary end point was new vertebral fracture. Secondary end points included nonvertebral and hip fractures. RESULTS: As compared with placebo, denosumab reduced the risk of new radiographic vertebral fracture, with a cumulative incidence of 2.3% in the denosumab group, versus 7.2% in the placebo group (risk ratio, 0.32; 95% confidence interval [CI], 0.26 to 0.41; P<0.001)--a relative decrease of 68%. Denosumab reduced the risk of hip fracture, with a cumulative incidence of 0.7% in the denosumab group, versus 1.2% in the placebo group (hazard ratio, 0.60; 95% CI, 0.37 to 0.97; P=0.04)--a relative decrease of 40%. Denosumab also reduced the risk of nonvertebral fracture, with a cumulative incidence of 6.5% in the denosumab group, versus 8.0% in the placebo group (hazard ratio, 0.80; 95% CI, 0.67 to 0.95; P=0.01)--a relative decrease of 20%. There was no increase in the risk of cancer, infection, cardiovascular disease, delayed fracture healing, or hypocalcemia, and there were no cases of osteonecrosis of the jaw and no adverse reactions to the injection of denosumab. CONCLUSIONS: Denosumab given subcutaneously twice yearly for 36 months was associated with a reduction in the risk of vertebral, nonvertebral, and hip fractures in women with osteoporosis. (ClinicalTrials.gov number, NCT00089791.)
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“This is true for fracture patients with BMD in both the low bone mass and osteoporosis range [49–58].”
From Clinician’s Guide to Prevention and Treatment of Osteoporosis (2014) · cites this paper as [56]
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“There are abundant data that patients with spine and hip fractures will have reduced fracture risk if treated with pharmacologic therapy.”
From Clinician’s Guide to Prevention and Treatment of Osteoporosis (2014) · cites this paper as [56]
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“Denosumab reduces the incidence of vertebral fractures by about 68 %, hip fractures by about 40 %, and nonvertebral fractures by about 20 % over 3 years [56].”
From Clinician’s Guide to Prevention and Treatment of Osteoporosis (2014) · cites this paper as [56]
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“Denosumab reduces the incidence of vertebral fractures by about 68 %, hip fractures by about 40 %, and nonvertebral fractures by about 20 % over 3 years [56].”
From Clinician’s Guide to Prevention and Treatment of Osteoporosis (2014) · cites this paper as [56]
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“Denosumab reduces the incidence of vertebral fractures by about 68 %, hip fractures by about 40 %, and nonvertebral fractures by about 20 % over 3 years [56].”
From Clinician’s Guide to Prevention and Treatment of Osteoporosis (2014) · cites this paper as [56]
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Metadata
- Authors
- 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., Kutilek, S., Adami, S., Zanchetta, J., Libanati, C., Siddhanti, S., & Christiansen, C.
- Affiliations
- University of California, San Francisco (US)
- Columbia University Irving Medical Center (US)
- University of Sheffield (GB)
- University of Auckland (NZ)
- Inserm (FR)
- Amgen (United States) (US)
- University of Verona (IT)
- Center for Clinical & Basic Research (DK)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2009-08-20
- Volume
- 361
- Issue
- 8
- Pages
- 756-765
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2160005424
- Cited by
- 3,489
- References
- 39
- Citations by year
- 2026: 187 · 2025: 220 · 2024: 203 · 2023: 164 · 2022: 226 · 2021: 210 · 2020: 223 · 2019: 200 · 2018: 208 · 2017: 195 · 2016: 180 · 2015: 238 · 2014: 168 · 2013: 222 · 2012: 197
- FWCI
- 223.08
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- BORIS (University Library Bern) (submittedVersion)
- Digital Access to Libraries (Université catholique de Louvain (UCL), l'Université de Namur (UNamur) and the Université Saint-Louis (USL-B)) (submittedVersion)
- Florence Research (University of Florence) (submittedVersion)
- IRIS (submittedVersion)
- IRIS Research product catalog (Sapienza University of Rome) (submittedVersion)
- Lithuanian University of Health Sciences (submittedVersion)
- ResearchSpace (University of Auckland) (submittedVersion, cc-by)
- SERVAL (Université de Lausanne) (submittedVersion)
- Use Siena air (University of Siena) (submittedVersion)
- Funders
- Amgen
- Eli Lilly and Company
- Pfizer
- AstraZeneca
- GlaxoSmithKline
- Servier
- Topics
- Health Sciences › Medicine › Orthopedics and Sports Medicine › Bone health and osteoporosis research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Bone Metabolism and Diseases
- Health Sciences › Medicine › Oncology › Bone health and treatments
- Keywords
- denosumab, osteoporosis, postmenopausal women, fracture prevention, RANKL inhibition, vertebral fractures, hip fracture, non-vertebral fractures, bone mineral density, monoclonal antibodies, osteoclasts, bone resorption, adverse events, osteonecrosis of the jaw, hypocalcemia, cancer risk, cardiovascular risk
- MeSH terms
- Denosumab, Aged, Aged, 80 and over, Antibodies, Monoclonal, Female, Hip Fractures, Humans, Middle Aged, Risk, Bone Density, Osteoporosis, Postmenopausal, Incidence, Spinal Fractures, Bone Remodeling, Bone Density Conservation Agents, Fractures, Bone, RANK Ligand, Antibodies, Monoclonal, Humanized
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