2018-003523-11: The study is investigating the use of an investigational medication (GP2411, a proposed biosimilar medicine to Prolia®) for postmenopausal women with osteoporosis. The aim of study is to understand the efficacy and safety of the medication as well as how the medication is processed by the body and the effect it has on the body and/or the disease. |
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| Not yet recruiting | 3 | 522 | RoW, Europe | Denosumab, Prolia, GP2411, Solution for injection in pre-filled syringe, Prolia | Hexal AG, Hexal AG | Osteoporosis is defined as a progressive, systemic skeletal disorder characterized by low bone mass and microarchitectural deterioration of bone tissue, with a consequent increase in bone fragility and susceptibility to fracture. Osteoporosis is estimated to affect 200 million women worldwide, approximately one-tenth of women aged 60, one-fifth of women aged 70, and two-fifths of women aged 80 (Johnell and Kanis 2006)., Osteoporosis is defined as a progressive, systemic skeletal disorder characterized by low bone mass and microarchitectural deterioration of bone tissue., Diseases [C] - Musculoskeletal Diseases [C05] | | | | |