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| 999 |
_c16876 _d16876 |
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| 003 | OSt | ||
| 005 | 20220624095630.0 | ||
| 008 | 220624b xxu||||| |||| 00| 0 eng d | ||
| 040 |
_aAIKTC-KRRC _cAIKTC-KRRC |
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| 100 |
_916770 _aSingh, Inderjeet |
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| 245 | _aDenosumab biosimilar in postmenopausal osteoporotic women: A randomized, assessor‑blind, active‑controlled clinical trial | ||
| 250 | _aVol.53(1), Jan-Feb | ||
| 260 |
_aMumbai _bWolter Kluwer _c2021 |
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| 300 | _a6-12p. | ||
| 520 | _aOBJECTIVE: The study assessed the efficacy, safety, pharmacokinetic (PK), and immunogenicity profiles of denosumab‑biosimilar and denosumab‑reference in postmenopausal osteoporotic women from India. MATERIALS AND METHODS: In this randomized, assessor‑blind, active‑control, multicenter trial, 114 patients were randomly allocated to receive denosumab‑biosimilar (n = 58) or denosumab‑reference (n = 56) at a subcutaneous dose of 60 mg every 6 months, for a year. Vitamin D and oral calcium were given daily. Lumbar spine bone mineral density (BMD) change was the primary end point. RESULTS: Of 114 randomized patients, 111 (denosumab‑biosimilar, n = 56; denosumab‑reference, n = 55) completed the study. All 114 patients were part of safety and immunogenicity analyses, 110 (denosumab‑biosimilar, n = 56; denosumab‑reference, n = 54) were part of efficacy analysis, and 20 (denosumab‑biosimilar, n = 10; denosumab‑reference, n = 10) were part of PK analysis. The bone mineral density (BMD) (lumbar spine) percent change at 1 year with denosumab‑biosimilar and denosumab‑reference (7.22 vs. 7.62; difference:−0.40; 95% confidence interval: −5.92, 5.12) showed no statistically relevant difference. Likewise, alkaline phosphatase (bone‑specific) and PK parameters also did not show statistically relevant differences. Adverse events were reported in 44.83% of patients on denosumab‑biosimilar versus 33.93% of patients on denosumab‑reference; most events were mild or moderate and not related to the study drugs. No patients showed anti‑denosumab antibody positivity. CONCLUSIONS: Denosumab‑biosimilar and denosumab‑reference showed biosimilarity in osteoporotic postmenopausal women. Availability of denosumab‑biosimilar provides a treatment alternative for patients. | ||
| 650 | 0 |
_94774 _aPHARMACOLOGY |
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| 700 |
_916771 _aJose, Vinu |
||
| 773 | 0 |
_x0253-7613 _tIndian Journal of Pharmacology _dAndheri - Mumbai Wolters Kluwer India Private Limited |
|
| 856 |
_uhttps://www.ijp-online.com/temp/IndianJPharmacol5316-1576306_042243.pdf _yClick here |
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| 942 |
_2ddc _cAR |
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