Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Patients With Multiple Myeloma

PHASE3CompletedINTERVENTIONAL
Enrollment

1,718

Participants

Timeline

Start Date

May 17, 2012

Primary Completion Date

July 19, 2016

Study Completion Date

March 29, 2019

Conditions
CancerHematologic MalignanciesMultiple MyelomaOncologyBone MetastasesMultiple Myeloma Bone Lesions
Interventions
DRUG

Denosumab

Administered by subcutaneous injection once every 4 weeks.

DRUG

Zoledronic acid

Administered by intravenous infusion over 15 minutes once every 4 weeks

DRUG

Placebo to Denosumab

Administered by subcutaneous injection once every 4 weeks.

DRUG

Placebo to zoledronic acid

Administered by intravenous infusion over 15 minutes once every 4 weeks

DRUG

Denosumab (for the open-label treatment phase)

Administered by subcutaneous injection once every 4 weeks.

Trial Locations (309)

7

Research Site, Dublin

8

Research Site, Dublin

24

Research Site, Dublin

407

Research Site, Taichung

1023

Research Site, Grafton, Auckland

1083

Research Site, Budapest

1090

Research Site, Vienna

1097

Research Site, Budapest

1140

Research Site, Vienna

1407

Research Site, Sofia

1431

Research Site, Sofia

1606

Research Site, Sofia

1756

Research Site, Sofia

2170

Research Site, Liverpool

2485

Research Site, Tweed Heads

3050

Research Site, Parkville

3076

Research Site, Epping

3144

Research Site, Malvern

3168

Research Site, Clayton

3181

Research Site, Prahran

3500

Research Site, Krems

4002

Research Site, Plovdiv

4032

Research Site, Debrecen

4101

Research Site, South Brisbane

4600

Research Site, Wels

4814

Research Site, Douglas

5020

Research Site, Salzburg

5700

Research Site, Gyula

5800

Research Site, Pleven

6020

Research Site, Innsbruck

6725

Research Site, Szeged

7000

Research Site, Hobart

Research Site, Chur

7400

Research Site, Kaposvár

8011

Research Site, Christchurch

8032

Research Site, Zurich

8036

Research Site, Graz

8038

Research Site, Zurich

9010

Research Site, Varna

9024

Research Site, Győr

10002

Research Site, Taipei

10021

Research Site, New York

10126

Research Site, Torino

10990

Research Site, George Town

11042

Research Site, Lake Success

11525

Research Site, Athens

11527

Research Site, Athens

11528

Research Site, Athens

13273

Research Site, Marseille

13385

Research Site, Marseille

14621

Research Site, Rochester

16132

Research Site, Genova

17033

Research Site, Hershey

18009

Research Site, Cherkasy

18537

Research Site, Piraeus

19106

Research Site, Philadelphia

19140

Research Site, Philadelphia

19141

Research Site, Philadelphia

19611

Research Site, West Reading

20007

Research Site, Washington D.C.

20010

Research Site, Washington D.C.

20014

Research Site, Donostia / San Sebastian

20089

Research Site, Rozzano MI

20153

Research Site, Milan

20246

Research Site, Hamburg

20817

Research Site, Bethesda

20871

Research Site, Vimercate MB

21052

Research Site, Busto Arsizio

21157

Research Site, Westminster

21204

Research Site, Baltimore

21229

Research Site, Baltimore

21237

Research Site, Baltimore

24073

Research Site, Christiansburg

25125

Research Site, Brescia

26500

Research Site, Pátrai

26506

Research Site, Morgantown

27262

Research Site, High Point

27534

Research Site, Goldsboro

28006

Research Site, Madrid

28034

Research Site, Madrid

28100

Research Site, Novara

28304

Research Site, Fayetteville

29000

Research Site, Khmelnitskiy

29406

Research Site, Charleston

29414

Research Site, Charleston

29615

Research Site, Greenville

30990

Research Site, Ipoh

31405

Research Site, Savannah

31904

Research Site, Columbus

32005

Research Site, Ourense

32256

Research Site, Jacksonville

33100

Research Site, Udine

33305

Research Site, Taoyuan District

33426

Research Site, Boynton Beach

33435

Research Site, Boynton Beach

33604

Research Site, Pessac

34125

Research Site, Kassel

34452

Research Site, Istanbul

35340

Research Site, Izmir

36024

Research Site, Poltava

37007

Research Site, Salamanca

38120

Research Site, Memphis

39216

Research Site, Jackson

40447

Research Site, Taichung

41013

Research Site, Seville

42003

Research Site, Paducah

44035

Research Site, Nantes

45239

Research Site, Essen

46016

Research Site, Anderson

46017

Research Site, Valencia

46026

Research Site, Valencia

46202

Research Site, Indianapolis

46845

Research Site, Fort Wayne

48149

Research Site, Münster

48201

Research Site, Detroit

48910

Research Site, Lansing

49102

Research Site, Dnipropetrovsk

50006

Research Site, Changhua

50009

Research Site, Kaunas

50010

Research Site, Ames

50134

Research Site, Florence

50924

Research Site, Cologne

51056

Research Site, Reims

52242

Research Site, Iowa City

53127

Research Site, Bonn

53226

Research Site, Wauwatosa

54548

Research Site, Minocqua

56127

Research Site, Pisa

57010

Research Site, Thessaloniki

57105

Research Site, Sioux Falls

57201

Research Site, Watertown

57401

Research Site, Aberdeen

57701

Research Site, Rapid City

58501

Research Site, Bismarck

59037

Research Site, Lille

59101

Research Site, Billings

60076

Research Site, Skokie

60077

Research Site, Skokie

60126

Research Site, Ancona

60153

Research Site, Maywood

60435

Research Site, Joliet

60612

Research Site, Chicago

60714

Research Site, Niles

65124

Research Site, Pescara

65806

Research Site, Springfield

67000

Research Site, Strasbourg

68000

Research Site, Ampang

68198

Research Site, Omaha

68506

Research Site, Lincoln

69400

Research Site, Villefranche-sur-Saône

69437

Research Site, Lyon Cédex 3

69495

Research Site, Pierre-Bénite

70121

Research Site, New Orleans

70124

Research Site, Bari

70403

Research Site, Tainan City

71110

Research Site, Heraklion

72000

Research Site, Le Mans

72037

Research Site, Le Mans

72703

Research Site, Fayetteville

75010

Research Site, Paris

75013

Research Site, Paris

75015

Research Site, Paris

75571

Research Site, Paris

75679

Research Site, Paris

76008

Research Site, Ivano-Frankivsk

76038

Research Site, Rouen

77030

Research Site, Houston

79031

Research Site, Lviv

79415

Research Site, Lubbock

80054

Research Site, Amiens

80131

Research Site, Napoli

80136

Research Site, Napoli

83301

Research Site, Kaohsiung City

84106

Research Site, Salt Lake City

84902

Research Site, Avignon

85704

Research Site, Tucson

89086

Research Site, North Las Vegas

90146

Research Site, Palermo

92024

Research Site, Encinitas

92801

Research Site, Anaheim

93049

Research Site, Regensburg

93105

Research Site, Santa Barbara

93454

Research Site, Santa Maria

93586

Research Site, Kuching

93720

Research Site, Fresno

94010

Research Site, Créteil

94270

Research Site, Le Kremlin-Bicêtre

94523

Research Site, Pleasant Hill

95008

Research Site, Campbell

95124

Research Site, Catania

95301

Research Site, Pontoise

98125

Research Site, Messina

98405

Research Site, Tacoma

99208

Research Site, Spokane

115478

Research Site, Moscow

119228

Research Site, Singapore

169856

Research Site, Singapore

185019

Research Site, Petrozavodsk

193312

Research Site, Saint Petersburg

197022

Research Site, Saint Petersburg

197110

Research Site, Saint Petersburg

198205

Research Site, Saint Petersburg

308433

Research Site, Singapore

400138

Research Site, Volgograd

410012

Research Site, Saratov

440071

Research Site, Penza

443099

Research Site, Samara

603126

Research Site, Nizhny Novgorod

606019

Research Site, Dzerzhinsk

620102

Research Site, Yekaterinburg

630051

Research Site, Novosibirsk

06902

Research Site, Stamford

04074

Research Site, Scarborough

02114

Research Site, Boston

02215

Research Site, Boston

01923

Research Site, Danvers

02719

Research Site, Fairhaven

07601

Research Site, Hackensack

73120-8345

Research Site, Oklahoma City

V5G 2X6

Research Site, Burnaby

R3E 0V9

Research Site, Winnipeg

E1C 6Z8

Research Site, Moncton

A1B 3V6

Research Site, St. John's

L4M 6M2

Research Site, Barrie

L3Y 2P9

Research Site, Newmarket

P6B 0A8

Research Site, Sault Ste. Marie

M2K 1E1

Research Site, Toronto

M3M 0B2

Research Site, Toronto

M5B 1W8

Research Site, Toronto

M6R 1B5

Research Site, Toronto

N8W 2X3

Research Site, Windsor

H7M 3L9

Research Site, Laval

H1T 2M4

Research Site, Montreal

H4J 1C5

Research Site, Montreal

G1R 2J6

Research Site, Québec

G8Z 3R9

Research Site, Trois-Rivières

625 00

Research Site, Brno

708 52

Research Site, Ostrava-Poruba

304 60

Research Site, Pilsen

100 34

Research Site, Prague

128 08

Research Site, Prague

06202

Research Site, Nice

02321

Research Site, Saint-Quentin

09113

Research Site, Chemnitz

04103

Research Site, Leipzig

Unknown

Research Site, Hong Kong

Research Site, New Territories

Research Site, Limerick

Research Site, Tullamore

00144

Research Site, Roma

00161

Research Site, Roma

457-8510

Research Site, Nagoya

010-8543

Research Site, Akita

296-8602

Research Site, Kamogawa-shi

814-0180

Research Site, Fukuoka

501-1194

Research Site, Gifu

503-8502

Research Site, Ogaki-shi

371-8511

Research Site, Maebashi

377-8511

Research Site, Shibukawa-shi

720-0001

Research Site, Fukuyama-shi

650-0047

Research Site, Kobe

860-0008

Research Site, Kumamoto

603-8151

Research Site, Kyoto

701-1192

Research Site, Okayama

350-8550

Research Site, Kawagoe-shi

770-8503

Research Site, Tokushima

150-8935

Research Site, Shibuya-ku

162-8655

Research Site, Shinjuku-ku

930-8550

Research Site, Toyama

LT-08661

Research Site, Vilnius

59-220

Research Site, Legnica

20-081

Research Site, Lublin

76-200

Research Site, Słupsk

87-100

Research Site, Torun

02-097

Research Site, Warsaw

02-776

Research Site, Warsaw

53-439

Research Site, Wroclaw

4710-243

Research Site, Braga

3000-075

Research Site, Coimbra

1169-050

Research Site, Lisbon

4464-513

Research Site, Matosinhos Municipality

4200-072

Research Site, Porto

851 07

Research Site, Bratislava

950 01

Research Site, Nitra

940 34

Research Site, Nové Zámky

431-070

Research Site, Anyang

602-739

Research Site, Busan

700-721

Research Site, Daegu

301-721

Research Site, Daejeon

519-763

Research Site, Gwangju

405-760

Research Site, Incheon

110-744

Research Site, Seoul

120-752

Research Site, Seoul

135-710

Research Site, Seoul

137-701

Research Site, Seoul

158-710

Research Site, Seoul

07198

Research Site, Palma de Mallorca

08916

Research Site, Badalona

08036

Research Site, Barcelona

01330

Research Site, Adana

06100

Research Site, Ankara

06500

Research Site, Ankara

04107

Research Site, Kyiv

HA1 3UJ

Research Site, Harrow

IV2 3UJ

Research Site, Inverness

LS9 7TF

Research Site, Leeds

NW3 2QG

Research Site, London

SW17 0RE

Research Site, London

OX3 7LJ

Research Site, Oxford

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Daiichi Sankyo

INDUSTRY

lead

Amgen

INDUSTRY