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Efficacy and safety of denosumab in postmenopausal women with osteopenia or osteoporosis: a systematic review and a meta-analysis.
- Source :
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Hormone and metabolic research = Hormon- und Stoffwechselforschung = Hormones et metabolisme [Horm Metab Res] 2009 Oct; Vol. 41 (10), pp. 721-9. Date of Electronic Publication: 2009 Jun 17. - Publication Year :
- 2009
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Abstract
- Receptor activator of nuclear factor-kappaB ligand (RANKL) is a cytokine essential for osteoclast differentiation, activation, and survival. Denosumab, a human monoclonal antibody against RANKL, constitutes a promising antiresorptive agent for osteoporosis. We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), and other trial registries through January 2009. We selected randomized controlled trials (RCTs) of denosumab in women with low bone mass that described the changes on bone markers and bone mineral density (BMD) as well as the adverse events including fracture risk. We analyzed data from nine RCTs involving 10 329 participants. Although denosumab universally decreased bone markers and increased lumbar and hip BMD, the efficacy evaluation based on percentage (%) mean change from the baseline was not possible due to missing data. Denosumab was not associated with a significant reduction in fracture risk [OR (95% CI) 0.74 (0.33 to 1.64), p=0.45]. Increased risk of serious adverse events [OR (95% CI) 1.83 (1.10 to 3.04), p=0.02] and serious infections [OR (95% CI) 4.45 (1.15 to 17.14), p=0.03] were evident. In conclusion, although effective as an antiresorptive agent, denosumab has not yet proved its efficacy on fracture risk reduction while increased infection risk questions its safety.<br /> (Georg Thieme Verlag KG Stuttgart.New York.)
- Subjects :
- Antibodies, Monoclonal adverse effects
Antibodies, Monoclonal therapeutic use
Antibodies, Monoclonal, Humanized
Bone Density drug effects
Bone Remodeling immunology
Denosumab
Female
Fractures, Bone immunology
Fractures, Bone prevention & control
Humans
Osteoporosis, Postmenopausal drug therapy
RANK Ligand adverse effects
RANK Ligand therapeutic use
Antibodies, Monoclonal pharmacology
Bone Density immunology
Osteoporosis, Postmenopausal immunology
RANK Ligand immunology
RANK Ligand pharmacology
Subjects
Details
- Language :
- English
- ISSN :
- 1439-4286
- Volume :
- 41
- Issue :
- 10
- Database :
- MEDLINE
- Journal :
- Hormone and metabolic research = Hormon- und Stoffwechselforschung = Hormones et metabolisme
- Publication Type :
- Academic Journal
- Accession number :
- 19536731
- Full Text :
- https://doi.org/10.1055/s-0029-1224109