Who is sponsoring NCT02157948?

NCT02157948 is sponsored by Amgen.

What condition does NCT02157948 study?

NCT02157948 studies Postmenopausal Osteoporosis.

What drugs are being tested in NCT02157948?

Interventions: Denosumab (CP2), Denosumab (CP4).

What is the status of NCT02157948?

NCT02157948 is currently COMPLETED.

Last reviewed 2017-07-18 · How we verify

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

NCT02157948 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Amgen
Phase	Phase 3
Status	COMPLETED
Enrolment	394
Start date	2014-05
Completion	2015-07

Conditions

Postmenopausal Osteoporosis

Interventions

Denosumab (CP2)
Denosumab (CP4)

Primary outcomes

Percent Change From Baseline in Lumbar Spine BMD — Baseline and Month 12
Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

Countries

United States, Canada, Denmark, Poland