Denosumab biosimilar in postmenopausal osteoporotic women: A randomized, assessor‑blind, active‑controlled clinical trial (Record no. 16876)
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| fixed length control field | a |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | OSt |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20220624095630.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 220624b xxu||||| |||| 00| 0 eng d |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | AIKTC-KRRC |
| Transcribing agency | AIKTC-KRRC |
| 100 ## - MAIN ENTRY--PERSONAL NAME | |
| 9 (RLIN) | 16770 |
| Author | Singh, Inderjeet |
| 245 ## - TITLE STATEMENT | |
| Title | Denosumab biosimilar in postmenopausal osteoporotic women: A randomized, assessor‑blind, active‑controlled clinical trial |
| 250 ## - EDITION STATEMENT | |
| Volume, Issue number | Vol.53(1), Jan-Feb |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. | |
| Place of publication, distribution, etc. | Mumbai |
| Name of publisher, distributor, etc. | Wolter Kluwer |
| Year | 2021 |
| 300 ## - PHYSICAL DESCRIPTION | |
| Pagination | 6-12p. |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | OBJECTIVE: The study assessed the efficacy, safety, pharmacokinetic (PK), and immunogenicity<br/>profiles of denosumab‑biosimilar and denosumab‑reference in postmenopausal osteoporotic women<br/>from India.<br/>MATERIALS AND METHODS: In this randomized, assessor‑blind, active‑control, multicenter<br/>trial, 114 patients were randomly allocated to receive denosumab‑biosimilar (n = 58) or<br/>denosumab‑reference (n = 56) at a subcutaneous dose of 60 mg every 6 months, for a year. Vitamin<br/>D and oral calcium were given daily. Lumbar spine bone mineral density (BMD) change was the<br/>primary end point.<br/>RESULTS: Of 114 randomized patients, 111 (denosumab‑biosimilar, n = 56; denosumab‑reference,<br/>n = 55) completed the study. All 114 patients were part of safety and immunogenicity analyses,<br/>110 (denosumab‑biosimilar, n = 56; denosumab‑reference, n = 54) were part of efficacy analysis,<br/>and 20 (denosumab‑biosimilar, n = 10; denosumab‑reference, n = 10) were part of PK analysis. The<br/>bone mineral density (BMD) (lumbar spine) percent change at 1 year with denosumab‑biosimilar<br/>and denosumab‑reference (7.22 vs. 7.62; difference:−0.40; 95% confidence interval: −5.92, 5.12)<br/>showed no statistically relevant difference. Likewise, alkaline phosphatase (bone‑specific) and PK<br/>parameters also did not show statistically relevant differences. Adverse events were reported in<br/>44.83% of patients on denosumab‑biosimilar versus 33.93% of patients on denosumab‑reference;<br/>most events were mild or moderate and not related to the study drugs. No patients showed<br/>anti‑denosumab antibody positivity.<br/>CONCLUSIONS: Denosumab‑biosimilar and denosumab‑reference showed biosimilarity in<br/>osteoporotic postmenopausal women. Availability of denosumab‑biosimilar provides a treatment<br/>alternative for patients. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| 9 (RLIN) | 4774 |
| Topical term or geographic name entry element | PHARMACOLOGY |
| 700 ## - ADDED ENTRY--PERSONAL NAME | |
| 9 (RLIN) | 16771 |
| Co-Author | Jose, Vinu |
| 773 0# - HOST ITEM ENTRY | |
| International Standard Serial Number | 0253-7613 |
| Title | Indian Journal of Pharmacology |
| Place, publisher, and date of publication | Andheri - Mumbai Wolters Kluwer India Private Limited |
| 856 ## - ELECTRONIC LOCATION AND ACCESS | |
| URL | https://www.ijp-online.com/temp/IndianJPharmacol5316-1576306_042243.pdf |
| Link text | Click here |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
| Source of classification or shelving scheme | Dewey Decimal Classification |
| Koha item type | Articles Abstract Database |
| Withdrawn status | Lost status | Source of classification or shelving scheme | Damaged status | Not for loan | Home library | Current library | Shelving location | Date acquired | Total Checkouts | Barcode | Date last seen | Price effective from | Koha item type |
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| Dewey Decimal Classification | School of Pharmacy | School of Pharmacy | Archieval Section | 24/06/2022 | 2022-0853 | 24/06/2022 | 24/06/2022 | Articles Abstract Database |