NCT02157948

A Double-blind Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis

A Multicenter, Double-blind, Randomized Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 394 (actual)
• Sponsor: Amgen · Industry
• Sex: Female
• Age: 55 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This study will compare the effect of denosumab produced by two different manufacturing processes on bone mineral density at the lumbar spine in postmenopausal women with osteoporosis.

Conditions

• Postmenopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	Denosumab (CP2)	Denosumab produced by a process referred to as CP2, administered subcutaneously from a prefilled syringe.
DRUG	Denosumab (CP4)	Denosumab produced by a process referred to as CP4, administered subcutaneously from a prefilled syringe.

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2014-06-06
• Last updated: 2017-08-16
• Results posted: 2017-08-16

Locations

23 sites across 4 countries: United States, Canada, Denmark, Poland