NCT02016716

A Randomized Phase 3 Study to Evaluate Two Formulations of Romosozumab in Postmenopausal Women With Osteoporosis

A Multicenter, Randomized, Multiple-dose Phase 3 Study to Evaluate the Noninferiority of Romosozumab at a 90 mg/mL Concentration Compared With a 70 mg/mL Concentration in Postmenopausal Women With Osteoporosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 294 (actual)
• Sponsor: Amgen · Industry
• Sex: Female
• Age: 55 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare 2 formulations of romosozumab (AMG 785) on bone mineral density (BMD) in postmenopausal women with osteoporosis.

Detailed description

Upon confirmation of eligibility, participants were randomized in a 22:5:22:5 ratio to the following treatment groups: * Romosozumab 90 mg/mL * Placebo 90 mg/mL * Romosozumab 70 mg/mL * Placebo 70 mg/mL After completing a 6-month treatment period, participants entered a 3-month follow-up period with an end of study (EOS) at month 9. For the analysis of efficacy endpoints, the 2 placebo groups were combined into a single placebo group. For safety analyses, the data for placebo were presented separately for each group.

Conditions

• Postmenopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	Romosozumab 90 mg/mL	Administered as 2 SC injections of a 90 mg/mL concentration in a 1.17 mL crystal zenith resin prefilled syringe (PFS).
DRUG	Placebo 90 mg/mL	Placebo administered as 2 SC injections with the 1.17 mL crystal zenith resin PFS.
DRUG	Romosozumab 70 mg/mL	Administered as 3 SC injections of a 70 mg/mL concentration in a 1.0 mL glass PFS.
DRUG	Placebo 70 mg/mL	Placebo administered as 3 SC injections with the 1.0 mL glass PFS.

Timeline

• Start date: 2013-12-03
• Primary completion: 2014-09-08
• Completion: 2014-12-08
• First posted: 2013-12-20
• Last updated: 2018-11-08
• Results posted: 2018-11-08

Locations

12 sites across 3 countries: United States, Czechia, Poland