Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis

PHASE3CompletedINTERVENTIONAL
Enrollment

4,093

Participants

Timeline

Start Date

May 4, 2012

Primary Completion Date

February 27, 2017

Study Completion Date

June 29, 2017

Conditions
Postmenopausal Women With Osteoporosis
Interventions
BIOLOGICAL

Romosozumab

Romosozumab 210 mg administered by subcutaneous injection once a month during the double-blind treatment phase.

DRUG

Alendronate

Alendronate 70 mg tablet taken once a week

DRUG

Placebo to Romosozumab

Administered by subcutaneous injection once a month during the double-blind treatment phase.

DRUG

Placebo to Alendronate

Matching placebo tablet taken once a week during the double-blind treatment phase.

Trial Locations (316)

8

Research Site, Dublin

1000

Research Site, Brussels

1011

Research Site, Riga

1012

Research Site, Riga

1023

Research Site, Grafton, Auckland

1036

Research Site, Budapest

1060

Research Site, Vienna

1083

Research Site, Budapest

1084

Research Site, Budapest

1114

Research Site, Ciudad Autonoma de Buenos Aires

1202

Research Site, Sofia

1421

Research Site, Sofia

1431

Research Site, Sofia

1504

Research Site, Sofia

1612

Research Site, Sofia

1709

Research Site, Sofia

2010

Research Site, Darlinghurst

2031

Research Site, Randwick

2143

Research Site, Kistarcsa

2196

Research Site, Johannesburg

2217

Research Site, Kogarah

2317

Research Site, Hamar

2408

Research Site, Elverum

2600

Research Site, Glostrup Municipality

2650

Research Site, Hvidovre

2750

Research Site, Ballerup Municipality

3000

Research Site, Leuven

3050

Research Site, Parkville

3081

Research Site, Heidelberg West

3128

Research Site, Box Hill

3220

Research Site, Geelong

3401

Research Site, Liepāja

3600

Research Site, Genk

4002

Research Site, Plovdiv

4005

Research Site, Stavanger

4010

Research Site, Linz

4020

Research Site, Liège

4032

Research Site, Debrecen

4600

Research Site, Køge

5000

Research Site, Odense

5600

Research Site, Békéscsaba

6400

Research Site, Kiskunhalas

7100

Research Site, Vejle

7130

Research Site, Somerset West

7400

Research Site, Kaposvár

7500

Research Site, Parow

7505

Research Site, Tygerberg

8000

Research Site, Bruges

Research Site, Århus C

8022

Research Site, Christchurch

8036

Research Site, Graz

8200

Research Site, Veszprém

8230

Research Site, Balatonfüred

8900

Research Site, Zalaegerszeg

9000

Research Site, Ghent

Research Site, Aalborg

9023

Research Site, Győr

10002

Research Site, Taipei

10124

Research Site, Santo Domingo

10126

Research Site, Torino

10128

Research Site, Tallinn

10323

Research Site, Vilnius

10514

Research Site, Santo Domingo

10605

Research Site, Santo Domingo

11021

Research Site, Great Neck

11525

Research Site, Athens

11526

Research Site, Athens

11527

Research Site, Athens

12200

Research Site, Berlin

12627

Research Site, Hellersdorf

14561

Research Site, Athens

15006

Research Site, A Coruña

15213

Research Site, Pittsburgh

16011

Research Site, Arenzano GE

16673

Research Site, Athens

18012

Research Site, Granada

19610

Research Site, Wyomissing

20100

Research Site, Turku

20145

Research Site, Milan

20354

Research Site, Hamburg

20817

Research Site, Bethesda

21100

Research Site, Mexicali

21200

Research Site, Mexicalli

23233

Research Site, Richmond

28006

Research Site, Madrid

28046

Research Site, Madrid

30167

Research Site, Hanover

30501

Research Site, Gainesville

31059

Research Site, Toulouse

31096

Research Site, Haifa

33076

Research Site, Bordeaux

33136

Research Site, Miami

33309

Research Site, Fort Lauderdale

33409

Research Site, West Palm Beach

34093

Research Site, Istanbul

34890

Research Site, Istanbul

34996

Research Site, Stuart

35043

Research Site, Marburg

35100

Research Site, Izmir

35294

Research Site, Birmingham

37000

Research Site, León

37126

Research Site, Verona

37134

Research Site, Verona

37520

Research Site, León

39008

Research Site, Santander

39104

Research Site, Magdeburg

40100

Research Site, Jyväskylä

40138

Research Site, Bologna

41009

Research Site, Seville

41110

Research Site, Larissa

42270

Research Site, Saint-Priest-en-Jarez

45067

Research Site, Orléans

46005

Research Site, Cahors

46202

Research Site, Indianapolis

48236

Research Site, Detroit

50139

Research Site, Florence

50410

Research Site, Tartu

51000

Research Site, Santiago de los Caballeros

51108

Research Site, Bnei Brak

52525

Research Site, Heinsberg

53100

Research Site, Siena

53105

Research Site, Bonn

53705

Research Site, Madison

54511

Research Site, Vandœuvre-lès-Nancy

54636

Research Site, Thessaloniki

56124

Research Site, Pisa

56126

Research Site, Pisa

56403

Research Site, Thessaloniki

56429

Research Site, Thessaloniki

58503

Research Site, Bismarck

59037

Research Site, Lille

60153

Research Site, Maywood

60528

Research Site, Frankfurt am Main

60596

Research Site, Frankfurt am Main

61999

Research Site, Tel Aviv

62301

Research Site, Quincy

63110

Research Site, St Louis

64460

Research Site, Monterrey

68003

Research Site, Bucaramanga

69437

Research Site, Lyon Cédex 3

70211

Research Site, Kuopio

70403

Research Site, Tainan City

71713

Research Site, Jerusalem

76000

Research Site, Querétaro City

79106

Research Site, Freiburg im Breisgau

80227

Research Site, Lakewood

80336

Research Site, München

85000

Research Site, Ciudad Obregón

85037

Research Site, Phoenix

85258

Research Site, Scottsdale

85381

Research Site, Peoria

88011

Research Site, Las Cruces

89148

Research Site, Las Vegas

90057

Research Site, Los Angeles

90242

Research Site, Downey

91007

Research Site, Jerusalem

92780

Research Site, Tustin

94598

Research Site, Walnut Creek

94904

Research Site, Greenbrae

95124

Research Site, Catania

96150

Research Site, South Lake Tahoe

97074

Research Site, Würzburg

98362

Research Site, Port Angeles

101990

Research Site, Moscow

110221

Research Site, Bogota

115522

Research Site, Moscow

117036

Research Site, Moscow

127299

Research Site, Moscow

150003

Research Site, Yaroslavl

153025

Research Site, Ivanovo

163001

Research Site, Arkhangelsk

185019

Research Site, Petrozavodsk

190103

Research Site, Saint Petersburg

194291

Research Site, Saint Petersburg

199034

Research Site, Saint Petersburg

410028

Research Site, Oradea

540142

Research Site, Târgu Mureş

603155

Research Site, Nizhny Novgorod

620102

Research Site, Yekaterinburg

8350595

Research Site, Santiago

11001000

Research Site, Bogota

Research Site, Bogotá

02114

Research Site, Boston

C1128AAF

Research Site, Ciudad Autonoma de Buenos Aires

C1430CKE

Research Site, Ciudad Autonoma de Buenos Aires

B7600DHK

Research Site, Mar del Plata

B1878DVB

Research Site, Quilmes

X5000BNB

Research Site, Córdoba

C1012AAR

Research Site, Buenos Aires

60115-282

Research Site, Fortaleza

29055-450

Research Site, Vitória

71625-009

Research Site, Brasília

74070-040

Research Site, Goiânia

80030-110

Research Site, Curitiba

52020-010

Research Site, Recife

22271-100

Research Site, Rio de Janeiro

04266-010

Research Site, São Paulo

05437-010

Research Site, São Paulo

V5Z 4E1

Research Site, Vancouver

R3A 1M3

Research Site, Winnipeg

A1B 3V6

Research Site, St. John's

B3H 2Y9

Research Site, Halifax

N2M 1A1

Research Site, Kitchener

M5C 2T2

Research Site, Toronto

M5G 2C4

Research Site, Toronto

H3T 1E2

Research Site, Montreal

H4A 3J1

Research Site, Montreal

G1V 3M7

Research Site, Québec

G8Z 1Y2

Research Site, Trois-Rivières

H3Z 1E5

Research Site, Westmout

050021

Research Site, Medellín

08001000

Research Site, Barranquilla

Unknown

Research Site, Bogota

Research Site, Hong Kong

Research Site, New Territories

Research Site, Cork

Research Site, Galway

602 00

Research Site, Brno

500 05

Research Site, Hradec Králové

339 38

Research Site, Klatovy

746 01

Research Site, Opava

722 00

Research Site, Ostrava-Trebovice

530 02

Research Site, Pardubice

305 99

Research Site, Pilsen

128 08

Research Site, Prague

130 00

Research Site, Prague

686 01

Research Site, Uherské Hradiště

760 01

Research Site, Zlín

00100

Research Site, Helsinki

01307

Research Site, Dresden

04103

Research Site, Leipzig

03001

Research Site, Antigua Guatemala

01001

Research Site, Guatemala City

01007

Research Site, Guatemala City

01009

Research Site, Guatemala City

01010

Research Site, Guatemala City

01012

Research Site, Guatemala City

01014

Research Site, Guatemala City

01015

Research Site, Guatemala City

01052

Research Site, Guatemala City

00161

Research Site, Roma

09310

Research Site, Vilnius

06100

Research Site, Mexico City

06700

Research Site, Mexico City

2333 ZA

Research Site, Leiden

3015 CE

Research Site, Rotterdam

5912 BL

Research Site, Venlo

0050

Research Site, Oslo

Lima 27

Research Site, Lima

Lima 33

Research Site, Lima

Lima11

Research Site, Lima

15-351

Research Site, Bialystok

15-879

Research Site, Bialystok

62-069

Research Site, Dabrowka Dopiewo

82-300

Research Site, Elblag

81-384

Research Site, Gdynia

44-100

Research Site, Gliwice

40-040

Research Site, Katowice

25-317

Research Site, Kielce

30-510

Research Site, Krakow

31-501

Research Site, Krakow

09-245

Research Site, Lodz

90-558

Research Site, Lodz

60-356

Research Site, Poznan

60-702

Research Site, Poznan

21-040

Research Site, Świdnik

87-100

Research Site, Torun

01-192

Research Site, Warsaw

02-507

Research Site, Warsaw

04-730

Research Site, Warsaw

50-088

Research Site, Wroclaw

51-124

Research Site, Wroclaw

53-224

Research Site, Wroclaw

011172

Research Site, Bucharest

011863

Research Site, Bucharest

020125

Research Site, Bucharest

030463

Research Site, Bucharest

974 01

Research Site, Banská Bystrica

813 69

Research Site, Bratislava

826 06

Research Site, Bratislava

040 15

Research Site, Kosice-Saca

984 01

Research Site, Lučenec

921 12

Research Site, Piešťany

911 01

Research Site, Trenčín

0181

Research Site, Pretoria

0184

Research Site, Pretoria

700-712

Research Site, Daegu

471-701

Research Site, Guri-si

501-757

Research Site, Gwangju

405-760

Research Site, Incheon

110-744

Research Site, Seoul

120-752

Research Site, Seoul

136-705

Research Site, Seoul

443-380

Research Site, Suwon-si, Gyeonggi-do

08003

Research Site, Barcelona

08970

Research Site, Sant Joan Despí

581 85

Research Site, Linköping

431 80

Research Site, Mölndal

141 86

Research Site, Stockholm

907 36

Research Site, Umeå

01330

Research Site, Adana

B15 2SQ

Research Site, Birmingham

CB2 0QQ

Research Site, Cambridge

CF14 5GJ

Research Site, Cardiff

PR7 7NA

Research Site, Chorley

EH4 2XU

Research Site, Edinburgh

G20 0SP

Research Site, Glasgow

L22 0LG

Research Site, Liverpool

M15 6SX

Research Site, Manchester

HA6 2RN

Research Site, Northwood

NR4 7TJ

Research Site, Norwich

RG2 0FT

Research Site, Reading

S5 7AU

Research Site, Sheffield

DA14 6LT

Research Site, Sidcup

WS11 5XY

Research Site, Staffordshire

CV34 5BW

Research Site, Warwick

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY