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

PHASE3CompletedINTERVENTIONAL
Enrollment

294

Participants

Timeline

Start Date

December 3, 2013

Primary Completion Date

September 8, 2014

Study Completion Date

December 8, 2014

Conditions
Postmenopausal Osteoporosis
Interventions
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.

Trial Locations (12)

20817

Research Site, Bethesda

30501

Research Site, Gainesville

602 00

Research Site, Brno

339 01

Research Site, Klatovy

686 01

Research Site, Uherské Hradiště

81-384

Research Site, Gdynia

44-100

Research Site, Gliwice

40-040

Research Site, Katowice

31-501

Research Site, Krakow

21-040

Research Site, Świdnik

01-192

Research Site, Warsaw

50-088

Research Site, Wroclaw

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY