TOP: Recombinant Human Parathyroid Hormone (ALX1-11) on Fracture Incidence in Women With Postmenopausal Osteoporosis

PHASE3CompletedINTERVENTIONAL
Enrollment

2,532

Participants

Timeline

Start Date

April 27, 2000

Primary Completion Date

November 7, 2003

Study Completion Date

November 7, 2003

Conditions
Osteoporosis
Interventions
DRUG

placebo

Daily subcutaneous injection with placebo

DRUG

ALX1-11

PTH (1-84) 100 mcg injected subcutaneously into the thigh or abdomen

Trial Locations (174)

1303

"'SHATENGAcad.Ivan Penchev", Sofia

1431

"'Multifunctional Hospital for Active Treatment Alexandrovska", Sofia

"'Multifunctional Hospital for Active Treatment Sv.Ivan Rilsky", Sofia

1504

"'SHATGOSheynovo", Sofia

3400

'Spitalul Clinic Judetean Cluj-Napoca, Cluj-Napoca

4002

"'Multifunctional Hospital for Active Treatment Sv.Georgy", Plovdiv

10003

'Beth Israël Medical Center, New York

10032

'College of Physicians and Surgeons, Columbia University, New York

10605

'Physicians Clinical Research Services, White Plains

11501

'Bone Mineral Research Center, Mineola

11794

'Stony Brook Clinical Research Trials Center, Stony Brook

11800

'Hospital de Mexico, Mexico City

13083

'UNICAMP, Campinas

14609

'Rochester Clinical Research Inc., Rochester

15213

'University of Pittsburgh Medical Center, Pittsburgh

16635

'Altoona Center for Clinical Research, Duncansville

19131

'Thomas Jefferson University, Philadelphia

19610

'Radiant Research, Wyomissing

19611

'Clinical Research Center of Reading LLP, West Reading

20007

'Georgetown University Medical Center, Washington D.C.

20020

'Hospital Santa Casa de Misericórdia do Rio de Janeiro, Rio de Janeiro

20221

'Hospital do Servidor Público do Rio de Janeiro, Rio de Janeiro

20817

'Bethesda Health Research Center, Bethesda

20902

'The Center for Rheumatology and Bone Research, Wheaton

21502

'The Osteoporosis and Clinical Trials Center, Cumberland

21702

'Arthritis & Osteoporosis Center of Maryland, Frederick

21740

'The Osteoporosis and Clinical Trials Center, Hagerstown

23294

'National Clinical Research, Inc., Richmond

23298

'MCV Physicians Program for Osteoporosis, Richmond

23606

'Center for Arthritis and Diabetes, Newport News

27710

'Duke University Medical Center, Durham

28210

'Carolina Bone and Joint - Charlotte, Charlotte

29204

'Columbia Arthritis Center, PA, Columbia

29621

'Radiant Research, Anderson

29651

'Radiant Research, Greer

30322

'The Emory Clinic, Atlanta

31020

'Hospital Clinical del Parque, Chihuahua City

31096

'Rambam Medical Center, Haifa

33021

'The Center for Diabetes and Endocrine Care, Hollywood

33136

'Osteoporosis Center University of Miami, Miami

33143

'The Centre for Arthritis and Rheumatic Diseases, South Miami

33409

'Palm Beach Research Center, West Palm Beach

33410

'Diabetes and Endocrinology Treatment Center, Palm Beach Gardens

33461

'Radiant Research - Lake Worth, Lake Worth

33486

'RASF - Clinical Research Center, Boca Raton

33702

'ICSL Clinical Studies, St. Petersburg

33907

'ICSL Clinical Studies, Fort Myers

34162

'Lin Medical Center, Haifa

34452

'Florida Wellcare Alliance, Inverness

34471

'Renstar Medical Group, Ocala

34684

'The Arthritis Center, Palm Harbor

34996

'Radiant Research - Stuart & LakeWorth, Stuart

35205

Capstone Clinical Trials, Birmingham

35294

'The University of Alabama at Birmingham, Birmingham

35801

'Rheumatology Associates of North Alabama, Huntsville

37000

'Hospital Aranda de la Parra, León

37404

'Clinsearch, Chattanooga

38101

'Hillel Yaffe Medical Center, Hadera

38654

'Desoto Family Medical Center, Olive Branch

44143

'David R. Mandel M.D. Inc., Mayfield

44195

'Cleveland Clinic Foundation, Cleveland

44340

'OPD Hospital Civil de Guadalajara Dr. Juan I. Menchaca, Guadalajara

44650

'Hospital Civil de Belem, Guadalajara

44670

'Medica Monraz, Guadalajara

46202

'University Hospital & Outpatient Center, Indianapolis

48236

'Michigan Bone & Mineral Clinic, Detroit

49100

'Rabin Medical Center, Petah Tikva

50322

'Mercy Arthritis and Osteoporosis Center, Des Moines

50670

'Universidade Federal de Pernambuco, Recife

52621

'Chaim Sheba Medical Center, Ramat Gan

52763

'Hospital Angeles de las Lomas, Huixquilucan

53226

'Medical College of Wisconsin, Milwaukee

53792

'University of Wisconsin Medical Foundation, Madison

57105

'Averna Research Institute, Sioux Falls

57201

'Brown Clinic, Watertown

57701

'Rapid City Medical Center, Rapid City

58103

Michael J. Lillestol, Fargo

58201

'Altru Health Systems/Altru Research Center, Grand Forks

58501

'Odyssey Research Services, Bismarck

58701

'Odyssey Research Services, Minot

60612

Rush-Prebyterian-St.Luke's Medical Center, Chicago

60637

'The University of Chicago, Chicago

61704

'ICSL-Clinical Studies, Bloomington

64040

'Hospital Universitario de Monterrey, Monterrey Nuevo Leon

65807

'St. John's Medical Research Group, Springfield

67208

'Wichita Clinic, Wichita

70121

'Ochsner Clinic, New Orleans

74114

'Oklahoma Center for Arthritis Therapy & Research, Inc., Tulsa

75235

'Radiant Research/Dallas, Dallas

77024

'Breco Research Inc., Houston

78229

'Diabetes & Glandular Disease Research Associates, P.A., San Antonio

'Radiant Research San Antonio, San Antonio

78240

"'Hospital Central Ignacio Morones Prieto", San Luis Potosí City

79705

'Diabetes Center of the Southwest, Midland

80060

'Universidade Federal do Paraná, Curitiba

80220

'Denver Arthritis Clinic, Denver

80227

'Colorado Center for Bone Research, Lakewood

80501

'Longmont Medical Research Network, Longmont

83702

'Intermountain Orthopaedics, Boise

84070

'Salt Lake Women's Center, Sandy City

84101

'Soroka Medical Center, Beersheba

84894

'Clalit Health Services, Beersheba

85013

'Radiant Research - Phoenix, Phoenix

87106

'New Mexico Clinical Research and Osteoporosis Center, Albuquerque

87108

'Lovelace Scientific Resources, Albuquerque

89106

'VA Southern NV Healthcare Systems, Las Vegas

90211

'Osteoporosis Medical Center, Beverly Hills

91240

'Hadassah University Hospital, Jerusalem

91730

'Boling Clinical Trials, Rancho Cucamonga

92108

'Radiant Research - San Diego, San Diego

92120

'S.D. Arthritis & Osteoporosis Medical Clinic, San Diego

92260

'Desert Medical Advances, Palm Desert

92354

'Loma Linda Osteoporosis Research Center, Loma Linda

92701

'Community Research Centers, Santa Ana

92801

'Robin K. Dore, M.D., Inc., Anaheim

94110

'San Francisco General Hospital, San Francisco

94304

'VA Palo Alto Health Care System, Palo Alto

94520

'East Bay Clinical Trial Center, Concord

94612

'The Foundation for Osteoporosis Research and Education, Oakland

96814

'Radiant Research, Honolulu

97504

'Osteoporosis Center, Medford

98104

Phillip J. Mease, Seattle

98105

'Osteoporosis Research Group, Seattle

98502

'South Puget Sound Clinical Research Center, Olympia

117036

'Scientific Center of Endocrinology of RAMS, Moscow

125047

"'JK Medicine", Moscow

125315

'Russian Academy for Advanced Medical Studies, Moscow

772021

"'CLINTRIAL DORIS Medical Centre", Bucharest

06518

'Northeast Clinical Research, LLC, Hamden

04401

'Maine Center for Osteoporosis Research & Education, Bangor

02115

'Brigham & Women's Hospital, Boston

02720

'Phase III Clinical Research, Fall River

01605

'Osteoporosis Research & Treatment Center, Worcester

03301

'Arthritis, Osteoporosis Muscle Skeletal Disease Center, Concord

08009

'Comprehensive Clinical Research, Berlin

07080

'Anderson and Collins Clinical Research Inc., South Plainfield

02903

'Rhode Island Hospital, Providence

02908

'Roger Williams Medical Center, Providence

05401

'Fletcher Allan Health Center, UHC Campus 1, Burlington

C1012AAR

'IDIM, Buenos Aires

C1117ABH

'Centro Médico T.I.E.M.P.O, Buenos Aires

C1221ADC

'Hospital Ramos Mejía, Buenos Aires

C1114AAI

'Centro de Osteopatias Medicas, Capital Federal

Unknown

'Pontifícia Universidade Católica de Campinas, Campinas

'Lis Maternity Hospital, Tel Aviv

'Centrul Medical Sabyc, Bucharest

01221

'Hospital Santa Casa de Misericórdia de São Paulo, São Paulo

04038

'Universidade Federal de São Paulo, São Paulo

04062

'Instituto de Saúde e Bem Estar da Mulher, São Paulo

04231

'Hospital Heliópolis, São Paulo

'T2N 4N1

'Heritage Medical Research Clinic, Calgary

V5Z 2N6

Osteoporosis Research Center, Vancouver

'R3A 1M3

'Manitoba Clinic, Winnipeg

L8N 1Y2

Charlton Medical Centre, Hamilton

N2M 5N6

Rafat Faraawi, Kitchener

'N6G 2M3

'Centre for Activity and Aging, London

N6A 4V2

St. Joseph's Health Centre, London

'H3A 1A1

'Royal Victoria Hospital, Montreal

L6J 1X8

Oakville Bone Center, Oakville

'K1H 8L6

Ottawa Hospital, Ottawa

'M4N 3M5

'Sunnybrook and Women's College Health Science Center, Toronto

'M5C 2T2

'St. Michael's Hospital, Toronto

'M5S 1B2

'Osteoporosis Research Program, Toronto

N8W 5L7

Jude F. Rodrigues, Windsor

C1A 6A4

'Riverside Medical Centre, Charlottetown

G7H 5H6

'Complexe Hospitalier de la Sagami, Chicoutimi

'H1T 1P6

'Centre d'Etude Clinique Montreal Inc., Montreal

'H1T 2M4

'Hopital Maisonneuve-Rosemont, Montreal

'H2X 1P1

'Centre de Recherche du CHUM - Hopital Saint-Luc, Montreal

G1V 3M7

Centre de Recherche - CORQ, Sainte-Foy

J1J 2B8

Novabyss Research Clinic, Sherbrooke

'S7K 0H6

'Saskatoon Osteoporosis Centre, Saskatoon

06100

'Osteosol, Mexico City

06700

'Instituto Mexicano de Investigacion Clinica, Mexico City

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY

NCT00172081 - TOP: Recombinant Human Parathyroid Hormone (ALX1-11) on Fracture Incidence in Women With Postmenopausal Osteoporosis | Biotech Hunter | Biotech Hunter