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Effects of denosumab on fracture and bone mineral density by level of kidney function.
- Source :
-
Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research [J Bone Miner Res] 2011 Aug; Vol. 26 (8), pp. 1829-35. - Publication Year :
- 2011
-
Abstract
- The incidences of osteoporosis and chronic kidney disease (CKD) both increase with increasing age, yet there is a paucity of data on treatments for osteoporosis in the setting of impaired kidney function. We examined the efficacy and safety of denosumab (DMAb) among subjects participating in the Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months (FREEDOM) Study. We estimated creatinine clearance (eGFR) using Cockcroft-Gault and classified levels of kidney function using the modified National Kidney Foundation classification of CKD. We examined incident fracture rates; changes in bone mineral density (BMD), serum calcium, and creatinine; and the incidence of adverse events after 36 months of follow-up in subjects receiving DMAb or placebo, stratified by level of kidney function. We used a subgroup interaction term to determine if there were differences in treatment effect by eGFR. Most (93%) women were white, and the mean age was 72.3 ± 5.2 years; 73 women had an eGFR of 15 to 29 mL/min; 2817, between 30 to 59 mL/min; 4069, between 60 to 89 mL/min, and 842 had an eGFR of 90 mL/min or greater. None had stage 5 CKD. Fracture risk reduction and changes in BMD at all sites were in favor of DMAb. The test for treatment by subgroup interaction was not statistically significant, indicating that treatment efficacy did not differ by kidney function. Changes in creatinine and calcium and the incidence of adverse events were similar between groups and did not differ by level of kidney function. It is concluded that DMAb is effective at reducing fracture risk and is not associated with an increase in adverse events among patients with impaired kidney function.<br /> (Copyright © 2011 American Society for Bone and Mineral Research.)
- Subjects :
- Aged
Aged, 80 and over
Antibodies, Monoclonal adverse effects
Antibodies, Monoclonal pharmacology
Antibodies, Monoclonal, Humanized
Bone Density drug effects
Bone Density Conservation Agents adverse effects
Bone Density Conservation Agents pharmacology
Creatinine blood
Denosumab
Female
Fractures, Bone blood
Glomerular Filtration Rate
Humans
Kidney Failure, Chronic blood
Kidney Failure, Chronic complications
Kidney Failure, Chronic physiopathology
Middle Aged
Odds Ratio
Placebos
RANK Ligand adverse effects
RANK Ligand pharmacology
Antibodies, Monoclonal therapeutic use
Bone Density physiology
Bone Density Conservation Agents therapeutic use
Fractures, Bone drug therapy
Fractures, Bone physiopathology
Kidney Function Tests
RANK Ligand therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1523-4681
- Volume :
- 26
- Issue :
- 8
- Database :
- MEDLINE
- Journal :
- Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research
- Publication Type :
- Academic Journal
- Accession number :
- 21491487
- Full Text :
- https://doi.org/10.1002/jbmr.403