Effects of denosumab on bone mineral density and bone turnover in postmenopausal women transitioning from alendronate therapy
| Autor: | Christian Roux, Claude Laurent Benhamou, S. Siddhanti, Javier San Martin, David L. Kendler, Henry G. Bone, Hoi-Shen Man, Jacques P. Brown, M. Lillestol |
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| Rok vydání: | 2009 |
| Předmět: |
medicine.medical_specialty
Endocrinology Diabetes and Metabolism Osteoporosis Urology Antibodies Monoclonal Humanized Collagen Type I Bone resorption Bone remodeling Bone Density Internal medicine medicine Humans Orthopedics and Sports Medicine Adverse effect Aged Demography Femoral neck Bone mineral Hip Lumbar Vertebrae Alendronate Bone Density Conservation Agents Femur Neck business.industry Alendronic acid RANK Ligand Antibodies Monoclonal Middle Aged medicine.disease Peptide Fragments Postmenopause medicine.anatomical_structure Denosumab Endocrinology Female Bone Remodeling Peptides business Biomarkers Procollagen medicine.drug |
| Zdroj: | Journal of Bone and Mineral Research. 25:72-81 |
| ISSN: | 1523-4681 0884-0431 |
| Popis: | Patients treated with bisphosphonates for osteoporosis may discontinue or require a switch to other therapies. Denosumab binds to RANKL and is a potent inhibitor of bone resorption that has been shown to increase bone mineral density (BMD) and decrease fracture risk in postmenopausal women with osteoporosis. This was a multicenter, international, randomized, double-blind, double-dummy study in 504 postmenopausal women > or = 55 years of age with a BMD T-score of -2.0 or less and -4.0 or more who had been receiving alendronate therapy for at least 6 months. Subjects received open-label branded alendronate 70 mg once weekly for 1 month and then were randomly assigned to either continued weekly alendronate therapy or subcutaneous denosumab 60 mg every 6 months and were followed for 12 months. Changes in BMD and biochemical markers of bone turnover were evaluated. In subjects transitioning to denosumab, total hip BMD increased by 1.90% at month 12 compared with a 1.05% increase in subjects continuing on alendronate (p < .0001). Significantly greater BMD gains with denosumab compared with alendronate also were achieved at 12 months at the lumbar spine, femoral neck, and 1/3 radius (all p < .0125). Median serum CTX levels remained near baseline in the alendronate group and were significantly decreased versus alendronate (p < .0001) at all time points with denosumab. Adverse events and serious adverse events were balanced between groups. No clinical hypocalcemic adverse events were reported. Transition to denosumab produced greater increases in BMD at all measured skeletal sites and a greater reduction in bone turnover than did continued alendronate with a similar safety profile in both groups. |
| Databáze: | OpenAIRE |
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