Efficacy and safety of narlumosbart, an anti-RANKL monoclonal antibody, in postmenopausal women with osteoporosis: a multi-center, randomized, double-blind, placebo- and active-controlled, phased II study.

ABSTRACT:

Background

This study aimed to preliminarily explore the efficacy and safety of narlumosbart, an anti-RANKL monoclonal antibody, in treating postmenopausal women with osteoporosis.

Methods

This multi-center, randomized, double -blind, placebo- and active-controlled study was conducted at 23 clinics across China between April 21, 2022 and April 19, 2023. Eligible patients were randomly assigned (1:1:1:1:1) to receive either 45 mg. 60 mg, 90 mg of narlumosbart, 60 mg of denosumab, or placebo, administered once every 6 months over a 12-month period, with the treatment allocation masked for participants, sponsors, and clinical investigators. The primary efficacy endpoint was the percentage change in lumbar spine bone mineral density (BMD) from baseline to 12 months. The secondar

SUBMITTER: Chi Y 

PROVIDER: S-EPMC12271762 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature