Denosumab or Zoledronic Acid in Postmenopausal Women With Osteoporosis Previously Treated With Oral Bisphosphonates
| Autor: | C. Wang, M. A. Bolognese, Jean-Yves Reginster, Steve Cummings, Henry G. Bone, Rachel B. Wagman, A. Singer, Edward Czerwiński, Nicola Pannacciulli, Paul D. Miller, Jorge Malouf, Jacques P. Brown, Bettina S. Nedergaard |
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| Rok vydání: | 2016 |
| Předmět: |
0301 basic medicine
medicine.medical_specialty Bone density Endocrinology Diabetes and Metabolism Clinical Biochemistry Osteoporosis Urology Administration Oral 030209 endocrinology & metabolism Context (language use) Zoledronic Acid Biochemistry Bone remodeling 03 medical and health sciences 0302 clinical medicine Endocrinology Double-Blind Method Bone Density Internal medicine medicine Humans Osteoporosis Postmenopausal Aged Femoral neck Bone mineral Bone Density Conservation Agents Diphosphonates Drug Substitution business.industry Biochemistry (medical) Imidazoles Original Articles Middle Aged medicine.disease Surgery 030104 developmental biology Zoledronic acid Denosumab medicine.anatomical_structure Female business medicine.drug |
| Zdroj: | JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau instname The Journal of Clinical Endocrinology and Metabolism |
| ISSN: | 1945-7197 0021-972X |
| DOI: | 10.1210/jc.2016-1801 |
| Popis: | Context: Denosumab and zoledronic acid (ZOL) are parenteral treatments for patients with osteoporosis. Objective: The objective of the study was to compare the effect of transitioning from oral bisphosphonates to denosumab or ZOL on bone mineral density (BMD) and bone turnover. Design and Setting: This was an international, multicenter, randomized, double-blind trial. Participants: A total of 643 postmenopausal women with osteoporosis previously treated with oral bisphosphonates participated in the study. Interventions: Subjects were randomized 1:1 to sc denosumab 60 mg every 6 months plus iv placebo once or ZOL 5 mg iv once plus sc placebo every 6 months for 12 months. Main Outcome Measures: Changes in BMD and bone turnover markers were measured. Results: BMD change from baseline at month 12 was significantly greater with denosumab compared with ZOL at the lumbar spine (primary end point; 3.2% vs 1.1%; P < .0001), total hip (1.9% vs 0.6%; P < .0001), femoral neck (1.2% vs −0.1%; P < .0001), and one-third radius (0.6% vs 0.0%; P < .05). The median decrease from baseline was greater with denosumab than ZOL for serum C-telopeptide of type 1 collagen at all time points after day 10 and for serum procollagen type 1 N-terminal propeptide at month 1 and at all time points after month 3 (all P < .05). Median percentage changes from baseline in serum intact PTH were significantly greater at months 3 and 9 with denosumab compared with ZOL (all P < .05). Adverse events were similar between groups. Three events consistent with the definition of atypical femoral fracture were observed (two denosumab and one ZOL). Conclusions: In postmenopausal women with osteoporosis previously treated with oral bisphosphonates, denosumab was associated with greater BMD increases at all measured skeletal sites and greater inhibition of bone remodeling compared with ZOL. Postmenopausal women with osteoporosis transitioned from oral bisphosphonates had greater BMD increases and greater inhibition of bone turnover with denosumab compared with zoledronic acid. |
| Databáze: | OpenAIRE |
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