Open Label Extension Study of PREOS
Public ClinicalTrials.gov record NCT00172133. 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.
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 Open Label Extension Study (OLES) of the Safety and Efficacy of Recombinant Human Parathyroid Hormone, rhPTH(1-84), ALX1-11, in Women With Postmenopausal Osteoporosis Who Participated in Protocol ALX1-11-93001 (TOP Study)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is an Open Label Extension Study (OLES) for patients who participated in the 18 month double-blind, placebo-controlled, Phase III trial (Protocol ALX1 11 93001 the TOP Study) studying the effect of ALX1-11, recombinant human parathyroid hormone, rhPTH(1-84), on vertebral fracture incidence. The primary objective of this study is to evaluate the safety of continued dosing with ALX1-11, up to a maximum of 24 months, in postmenopausal osteoporotic women who participated in Protocol ALX1 11 93001.
Study identification
- NCT ID
- NCT00172133
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,683 participants
Conditions and interventions
Conditions
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
- Oct 15, 2001
- Primary completion
- Apr 12, 2005
- Completion
- Apr 12, 2005
- Last update posted
- May 16, 2021
2001 – 2005
United States locations
- U.S. sites
- 84
- U.S. states
- 39
- U.S. cities
- 78
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 'The University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| 'Rheumatology Associates of North Alabama | Huntsville | Alabama | 35801 | — |
| 'Radiant Research - Phoenix North | Phoenix | Arizona | 85013 | — |
| 'Osteoporosis Medical Center | Beverly Hills | California | 90211 | — |
| 'East Bay Clinical Trial Center | Concord | California | 94520 | — |
| 'Loma Linda Osteoporosis Research Center | Loma Linda | California | 92354 | — |
| Foundation for Osteoporosis Research | 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 | — |
| 'S.D. Arthritis & Osteoporosis Medical Clinic | San Diego | California | 92120 | — |
| 'Radiant Research - San Diego | San Diego | California | 92123 | — |
| 'San Francisco General Hospital | San Francisco | California | 94110 | — |
| 'Longmont Medical Research Network | Longmont | Colorado | 80501 | — |
| 'Northeast Clinical Research, LLC | Hamden | Connecticut | 06518 | — |
| 'RASF - Clinical Research Center | Boca Raton | Florida | 33486 | — |
| 'The Center for Diabetes and Endocrine Care | Hollywood | Florida | 33021 | — |
| 'Florida Wellcare Alliance | Inverness | Florida | 34452 | — |
| 'Renstar Medical Group | Ocala | Florida | 34471 | — |
| 'The Arthritis Center | Palm Harbor | Florida | 34684 | — |
| 'The Centre for Arthritis and Rheumatic Diseases | South Miami | Florida | 33143 | — |
| 'Radiant Research - Stuart & LakeWorth | Stuart | Florida | 34996 | — |
| 'Palm Beach Research Center | West Palm Beach | Florida | 33409 | — |
| 'Radiant Research | Honolulu | Hawaii | 96814 | — |
| 'Intermountain Orthopaedics | Boise | Idaho | 83702 | — |
| 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 Center for Rheumatology and Bone Research | Wheaton | Maryland | 20902 | — |
| 'Brigham & Women's Hospital | Boston | Massachusetts | 02115 | — |
| 'Michigan Bone & Mineral Clinic | Detroit | Michigan | 48236 | — |
| 'Desoto Family Medical Center | Olive Branch | Mississippi | 38654 | — |
| 'St. John's Medical Research Group | Springfield | Missouri | 65807 | — |
| 'Arthritis, Osteoporosis Muscle Skeletal Disease Center | Concord | New Hampshire | 03301 | — |
| '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 | — |
| '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 | — |
| '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 | — |
| '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 48 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00172133, 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 16, 2021 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00172133 live on ClinicalTrials.gov.