Randomized, Doubel-blinded, Parallel, Active-controlled Phase III Study, to Evaluate the Efficacy and Safety of CMAB807 Treatment Compared with Prolia® in Chinese Postmenopausal Women with Osteoporosis At High Risk of Fracture
Abstract
evaluate the differences in effectiveness and safety between CMAB807( potential biosimilar) and Prolia(original product)
Conditions: Postmenopausal Osteoporosis.
Primary outcome: BMD percentage change from baseline at lumbar spine(L1~L4).
Enrollment: 278 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 278 participants or records.
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