NCT05067335

A Study to Test the Efficacy, Safety and Tolerability of Romosozumab Treatment in Postmenopausal Chinese Women With Osteoporosis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Romosozumab Treatment in Postmenopausal Chinese Women With Osteoporosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 327 (actual)
• Sponsor: UCB Biopharma SRL · Industry
• Sex: Female
• Age: 55 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the effect of treatment with romosozumab for 6 months compared with placebo on the percent changes in bone mineral density (BMD) at the lumbar spine, at the total hip and femoral neck in postmenopausal Chinese women with osteoporosis.

Conditions

• Osteoporosis

Interventions

Type	Name	Description
DRUG	Romosozumab	Subjects will receive romosozumab in a specified sequence during the treatment Period.
DRUG	Placebo	Subjects will receive Placebo in a specified sequence during the treatment Period.

Timeline

• Start date: 2021-10-21
• Primary completion: 2023-11-09
• Completion: 2023-11-09
• First posted: 2021-10-05
• Last updated: 2024-12-05
• Results posted: 2024-12-05

Locations

30 sites across 1 country: China

Regulatory

• FDA-regulated drug study