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Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT00172081

Public ClinicalTrials.gov record NCT00172081. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 4:58 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An 18-Month Double-Blind, Placebo-Controlled, Phase III, Trial With a 12-Month Interim Analysis of the Effect of Recombinant Human Parathyroid Hormone (ALX1-11) on Fracture Incidence in Women With Postmenopausal Osteoporosis

Study identification

NCT ID
NCT00172081
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Shire
Industry
Enrollment
2,532 participants

Conditions and interventions

Conditions

Interventions

  • placebo Drug
  • ALX1-11 Drug

Drug

Eligibility (public fields only)

Age range
45 Years and older
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 26, 2000
Primary completion
Nov 6, 2003
Completion
Nov 6, 2003
Last update posted
May 13, 2021

2000 – 2003

United States locations

U.S. sites
107
U.S. states
42
U.S. cities
98
Facility City State ZIP Site status
Capstone Clinical Trials Birmingham Alabama 35205
'The University of Alabama at Birmingham Birmingham Alabama 35294
'Rheumatology Associates of North Alabama Huntsville Alabama 35801
'Radiant Research - Phoenix Phoenix Arizona 85013
'Robin K. Dore, M.D., Inc. Anaheim California 92801
'Osteoporosis Medical Center Beverly Hills California 90211
'East Bay Clinical Trial Center Concord California 94520
'Loma Linda Osteoporosis Research Center Loma Linda California 92354
'The Foundation for Osteoporosis Research and Education Oakland California 94612
'Desert Medical Advances Palm Desert California 92260
'VA Palo Alto Health Care System Palo Alto California 94304
'Boling Clinical Trials Rancho Cucamonga California 91730
'Radiant Research - San Diego San Diego California 92108
'S.D. Arthritis & Osteoporosis Medical Clinic San Diego California 92120
'San Francisco General Hospital San Francisco California 94110
'Community Research Centers Santa Ana California 92701
'Denver Arthritis Clinic Denver Colorado 80220
'Colorado Center for Bone Research Lakewood Colorado 80227
'Longmont Medical Research Network Longmont Colorado 80501
'Northeast Clinical Research, LLC Hamden Connecticut 06518
'Georgetown University Medical Center Washington D.C. District of Columbia 20007
'RASF - Clinical Research Center Boca Raton Florida 33486
'ICSL Clinical Studies Fort Myers Florida 33907
'The Center for Diabetes and Endocrine Care Hollywood Florida 33021
'Florida Wellcare Alliance Inverness Florida 34452
'Radiant Research - Lake Worth Lake Worth Florida 33461
'Osteoporosis Center University of Miami Miami Florida 33136
'Renstar Medical Group Ocala Florida 34471
'Diabetes and Endocrinology Treatment Center Palm Beach Gardens Florida 33410
'The Arthritis Center Palm Harbor Florida 34684
'The Centre for Arthritis and Rheumatic Diseases South Miami Florida 33143
'ICSL Clinical Studies St. Petersburg Florida 33702
'Radiant Research - Stuart & LakeWorth Stuart Florida 34996
'Palm Beach Research Center West Palm Beach Florida 33409
'The Emory Clinic Atlanta Georgia 30322
'Radiant Research Honolulu Hawaii 96814
'Intermountain Orthopaedics Boise Idaho 83702
'ICSL-Clinical Studies Bloomington Illinois 61704
Rush-Prebyterian-St.Luke's Medical Center Chicago Illinois 60612
'The University of Chicago Chicago Illinois 60637
'University Hospital & Outpatient Center Indianapolis Indiana 46202
'Mercy Arthritis and Osteoporosis Center Des Moines Iowa 50322
'Wichita Clinic Wichita Kansas 67208
'Ochsner Clinic New Orleans Louisiana 70121
'Maine Center for Osteoporosis Research & Education Bangor Maine 04401
'Bethesda Health Research Center Bethesda Maryland 20817
'The Osteoporosis and Clinical Trials Center Cumberland Maryland 21502
'Arthritis & Osteoporosis Center of Maryland Frederick Maryland 21702
'The Osteoporosis and Clinical Trials Center Hagerstown Maryland 21740
'The Center for Rheumatology and Bone Research Wheaton Maryland 20902
'Brigham & Women's Hospital Boston Massachusetts 02115
'Phase III Clinical Research Fall River Massachusetts 02720
'Osteoporosis Research & Treatment Center Worcester Massachusetts 01605
'Michigan Bone & Mineral Clinic Detroit Michigan 48236
'Desoto Family Medical Center Olive Branch Mississippi 38654
'St. John's Medical Research Group Springfield Missouri 65807
'VA Southern NV Healthcare Systems Las Vegas Nevada 89106
'Arthritis, Osteoporosis Muscle Skeletal Disease Center Concord New Hampshire 03301
'Comprehensive Clinical Research Berlin New Jersey 08009
'Anderson and Collins Clinical Research Inc. South Plainfield New Jersey 07080
'New Mexico Clinical Research and Osteoporosis Center Albuquerque New Mexico 87106
'Lovelace Scientific Resources Albuquerque New Mexico 87108
'Bone Mineral Research Center Mineola New York 11501
'Beth Israël Medical Center New York New York 10003
'College of Physicians and Surgeons, Columbia University New York New York 10032
'Rochester Clinical Research Inc. Rochester New York 14609
'Stony Brook Clinical Research Trials Center Stony Brook New York 11794
'Physicians Clinical Research Services White Plains New York 10605
'Carolina Bone and Joint - Charlotte Charlotte North Carolina 28210
'Duke University Medical Center Durham North Carolina 27710
'Odyssey Research Services Bismarck North Dakota 58501
Michael J. Lillestol Fargo North Dakota 58103
'Altru Health Systems/Altru Research Center Grand Forks North Dakota 58201
'Odyssey Research Services Minot North Dakota 58701
'Cleveland Clinic Foundation Cleveland Ohio 44195
'David R. Mandel M.D. Inc. Mayfield Ohio 44143
'Oklahoma Center for Arthritis Therapy & Research, Inc. Tulsa Oklahoma 74114
'Osteoporosis Center Medford Oregon 97504
'Altoona Center for Clinical Research Duncansville Pennsylvania 16635
'Thomas Jefferson University Philadelphia Pennsylvania 19131
'University of Pittsburgh Medical Center Pittsburgh Pennsylvania 15213
'Clinical Research Center of Reading LLP West Reading Pennsylvania 19611
'Radiant Research Wyomissing Pennsylvania 19610
'Rhode Island Hospital Providence Rhode Island 02903
'Roger Williams Medical Center Providence Rhode Island 02908
'Radiant Research Anderson South Carolina 29621
'Columbia Arthritis Center, PA Columbia South Carolina 29204
'Radiant Research Greer South Carolina 29651
'Rapid City Medical Center Rapid City South Dakota 57701
'Averna Research Institute Sioux Falls South Dakota 57105
'Brown Clinic Watertown South Dakota 57201
'Clinsearch Chattanooga Tennessee 37404
'Radiant Research/Dallas Dallas Texas 75235
'Breco Research Inc. Houston Texas 77024
'Diabetes Center of the Southwest Midland Texas 79705
'Diabetes & Glandular Disease Research Associates, P.A. San Antonio Texas 78229
'Radiant Research San Antonio San Antonio Texas 78229
'Salt Lake Women's Center Sandy City Utah 84070
'Fletcher Allan Health Center, UHC Campus 1 Burlington Vermont 05401
'Center for Arthritis and Diabetes Newport News Virginia 23606
'National Clinical Research, Inc. Richmond Virginia 23294
'MCV Physicians Program for Osteoporosis Richmond Virginia 23298
'South Puget Sound Clinical Research Center Olympia Washington 98502
Phillip J. Mease Seattle Washington 98104
'Osteoporosis Research Group Seattle Washington 98105
'University of Wisconsin Medical Foundation Madison Wisconsin 53792
'Medical College of Wisconsin Milwaukee Wisconsin 53226

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 67 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00172081, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 13, 2021 · Synced Jul 22, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00172081 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →