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

PHASE3CompletedINTERVENTIONAL
Enrollment

394

Participants

Timeline

Start Date

May 31, 2014

Primary Completion Date

July 31, 2015

Study Completion Date

July 31, 2015

Conditions
Postmenopausal Osteoporosis
Interventions
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.

Trial Locations (23)

2750

Research Site, Ballerup Municipality

7100

Research Site, Vejle

9000

Research Site, Aalborg

16635

Research Site, Duncansville

20817

Research Site, Bethesda

30501

Research Site, Gainesville

44311

Research Site, Akron

48236

Research Site, Detroit

80227

Research Site, Lakewood

87106

Research Site, Albuquerque

93454

Research Site, Santa Maria

96150

Research Site, South Lake Tahoe

97701

Research Site, Bend

V5Z 4E1

Research Site, Vancouver

G1V 3M7

Research Site, Québec

H3Z 1E5

Research Site, Westmout

15-351

Research Site, Bialystok

44-100

Research Site, Gliwice

31-501

Research Site, Krakow

90-368

Research Site, Lodz

90-558

Research Site, Lodz

21-040

Research Site, Świdnik

04-730

Research Site, Warsaw

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY

NCT02157948 - A Double-blind Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis | Biotech Hunter | Biotech Hunter