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      Romosozumab for the treatment of osteoporosis

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          Abstract

          Romosozumab, a specific inhibitor of sclerostin, is a unique approach to therapy for postmenopausal osteoporosis and related disorders. The elucidation of sclerostin deficiency as the molecular defect of syndromes of high bone mass with normal quality, and the pivotal role of sclerostin as a mediator of osteoblastic activity and bone formation, provided the platform for the evaluation of inhibitors of sclerostin to activate bone formation. An extensive preclinical program and 2 large fracture endpoint trials with romosozumab, a sclerostin-binding antibody, have been completed. This review will highlight the results of those studies and describe the current status of romosozumab as a potential therapy for osteoporosis.

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          Romosozumab in postmenopausal women with low bone mineral density.

          Michael McClung, Andreas Grauer, Steven Boonen … (2014)
          Sclerostin is an osteocyte-derived inhibitor of osteoblast activity. The monoclonal antibody romosozumab binds to sclerostin and increases bone formation.
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            Single-dose, placebo-controlled, randomized study of AMG 785, a sclerostin monoclonal antibody.

            Desmond Padhi, Graham Jang, Brian Stouch … (2011)
            Sclerostin, an osteocyte-secreted protein, negatively regulates osteoblasts and inhibits bone formation. In this first-in-human study, a sclerostin monoclonal antibody (AMG 785) was administered to healthy men and postmenopausal women. In this phase I, randomized, double-blind, placebo-controlled, ascending, single-dose study, 72 healthy subjects received AMG 785 or placebo (3:1) subcutaneously (0.1, 0.3, 1, 3, 5, or 10 mg/kg) or intravenously (1 or 5 mg/kg). Depending on dose, subjects were followed for up to 85 days. The effects of AMG 785 on safety and tolerability (primary objectives) and pharmacokinetics, bone turnover markers, and bone mineral density (secondary objectives) were evaluated. AMG 785 generally was well tolerated. One treatment-related serious adverse event of nonspecific hepatitis was reported and was resolved. No deaths or study discontinuations occurred. AMG 785 pharmacokinetics were nonlinear with dose. Dose-related increases in the bone-formation markers procollagen type 1 N-propeptide (P1NP), bone-specific alkaline phosphatase (BAP), and osteocalcin were observed, along with a dose-related decrease in the bone-resorption marker serum C-telopeptide (sCTx), resulting in a large anabolic window. In addition, statistically significant increases in bone mineral density of up to 5.3% at the lumbar spine and 2.8% at the total hip compared with placebo were observed on day 85. Six subjects in the higher-dose groups developed anti-AMG 785 antibodies, 2 of which were neutralizing, with no discernible effect on the pharmacokinetics or pharmacodynamics. In summary, single doses of AMG 785 generally were well tolerated, and the data support further clinical investigation of sclerostin inhibition as a potential therapeutic strategy for conditions that could benefit from increased bone formation. © 2011 American Society for Bone and Mineral Research.
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              Romosozumab (sclerostin monoclonal antibody) versus teriparatide in postmenopausal women with osteoporosis transitioning from oral bisphosphonate therapy: a randomised, open-label, phase 3 trial

              Nadia S. Daizadeh, Tony Keaveny, Esteban Jodar-Gimeno … (2017)
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                Author and article information

                Contributors
                Michael R. McClung
                Journal
                Journal ID (nlm-ta): Osteoporos Sarcopenia
                Journal ID (iso-abbrev): Osteoporos Sarcopenia
                Title: Osteoporosis and Sarcopenia
                Publisher: Korean Society of Osteoporosis
                ISSN (Print): 2405-5255
                ISSN (Electronic): 2405-5263
                Publication date PMC-release: 27 March 2018
                Publication date (Print): March 2018
                Publication date (Electronic): 27 March 2018
                Volume: 4
                Issue: 1
                Pages: 11-15
                Affiliations
                [1]Oregon Osteoporosis Center, Portland, OR, USA
                Author notes
                [∗ ]Oregon Osteoporosis Center, 2881 NW Cumberland Road, Portland, OR, 97210, USA. mmcclung.ooc@ 123456gmail.com
                Article
                Publisher ID: S2405-5255(18)30006-2
                DOI: 10.1016/j.afos.2018.03.002
                PMC ID: 6362945
                PubMed ID: 30775535
                SO-VID: 5f8768ce-ddc1-444c-8a0b-3b712d4c0e13
                Copyright © © 2018 The Korean Society of Osteoporosis. Publishing services by Elsevier B.V.
                License:

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

                History
                Date received : 8 February 2018
                Date revision received : 7 March 2018
                Date accepted : 10 March 2018
                Categories
                Subject: Review Article

                Keywords: romosozumab,sclerostin,osteoporosis,fracture risk,manuscript category
                Data availability:
                Keywords: romosozumab, sclerostin, osteoporosis, fracture risk, manuscript category

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