Safety and Efficacy Study to Evaluate Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis

PHASE4CompletedINTERVENTIONAL
Enrollment

643

Participants

Timeline

Start Date

November 7, 2012

Primary Completion Date

January 7, 2015

Study Completion Date

January 7, 2015

Conditions
Post Menopausal Osteoporosis
Interventions
BIOLOGICAL

Denosumab

Denosumab 60 mg administered by subcutaneous injection once every 6 months.

DRUG

Zoledronic Acid

Zoledronic acid 5 mg administered by intravenous infusion once a year

DRUG

Placebo to Denosumab

Administered by subcutaneous injection once every 6 months

DRUG

Placebo to Zoledronic Acid

Administered by intravenous infusion once a year

Trial Locations (45)

1000

Research Site, Brussels

1020

Research Site, Brussels

1050

Research Site, Brussels

1090

Research Site, Brussels

2035

Research Site, Maroubra

2065

Research Site, St Leonards

2170

Research Site, Merksem

2610

Research Site, Wilrijk

2750

Research Site, Penrith

Research Site, Ballerup Municipality

3000

Research Site, Leuven

3050

Research Site, Parkville

3128

Research Site, Box Hill

3220

Research Site, Geelong

3600

Research Site, Genk

3980

Research Site, Tessenderlo

4020

Research Site, Liège

5530

Research Site, Yvoir

7100

Research Site, Vejle

9000

Research Site, Aalborg

10993

Research Site, West Haverstraw

18012

Research Site, Granada

20007

Research Site, Washington D.C.

20817

Research Site, Bethesda

21740

Research Site, Hagerstown

28009

Research Site, Madrid

28040

Research Site, Madrid

48236

Research Site, Detroit

77074

Research Site, Houston

80227

Research Site, Lakewood

80501

Research Site, Longmont

90404

Research Site, Santa Monica

T2N 4Z6

Research Site, Calgary

V5Z 4E1

Research Site, Vancouver

B3H 2Y9

Research Site, Halifax

M5C 2T2

Research Site, Toronto

M5G 2C4

Research Site, Toronto

M9W 4L6

Research Site, Toronto

G1V 3M7

Research Site, Québec

15-879

Research Site, Bialystok

31-501

Research Site, Krakow

87-100

Research Site, Torun

01-192

Research Site, Warsaw

08036

Research Site, Barcelona

08041

Research Site, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY

NCT01732770 - Safety and Efficacy Study to Evaluate Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis | Biotech Hunter | Biotech Hunter