Open Label Extension Study of PREOS
OLES
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)
1 other identifier
interventional
1,683
8 countries
132
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2001
Typical duration for phase_3
132 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 16, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 13, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 13, 2005
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedMay 17, 2021
May 1, 2021
3.5 years
September 12, 2005
May 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 (TOP).
24 months of treatment
Secondary Outcomes (1)
To evaluate the continued efficacy of once-daily treatment with ALX1-11 for maintaining increases in BMD and other measures of bone quality and strength.
24 months of treatment
Study Arms (1)
1
EXPERIMENTALAll patients entering the study will receive 100mcg daily for up to 6 months, making their total exposure 24 months
Interventions
100 mcg PTH(1-84) injected subcutaneously daily in either the thrigh and abdomen.
Eligibility Criteria
You may qualify if:
- Women who completed 18 months of treatment in Protocol ALX1-11-93001; or
- Women prematurely discontinued from Protocol ALX1-11-93001 who want to participate in OLES for the events listed below must have their clinical course reviewed and approved by the CAB for enrollment into the OLES:
- Clinical or incident lumbar vertebral fractures as assessed by the central imaging organization
- Clinical or incident hip fracture
- Confirmed bone loss at A/P lumbar vertebra or total hip or femoral neck as assessed by the central imaging organization
- Body weight below 40 kg
- It must be accepted by patients whose clinical courses are reviewed by the CAB that participation in OLES may require additional tests at baseline and/or during the study to ensure their utmost safety.
- Women with the ability to self-administer a daily injection or have a designee who will give the injections;
- Women who are capable of understanding and giving written, voluntary informed consent before the start of open-label dosing with ALX1-11.
You may not qualify if:
- A. History or Concurrent Illness:
- Disorders of Immunity Endocrine system Gastrointestinal system Kidney and collecting system Liver, biliary tract and pancreatic systems Musculoskeletal system
- Patients with chronic, active joint disease requiring more than one intra-articular injection every 6 months Neoplasia
- Patients who have had squamous or basal cell carcinoma of the skin may enter this study if:
- The lesion(s) were fully resected with clear margins described in a written report by a pathologist, and
- The patient has had no recurrence of lesions for at least one year from the time of the original resection.
- Nervous system Vascular, respiratory and cardiac system \*Significant diseases or disorders are determined by history, physical exam or laboratory tests and judged by the Principal Investigator to be significant.
- B. Concurrent Medication:
- Patients may not use any of the following therapies while they are enrolled in this OLES without permission from the Sponsor and the PMO:
- Tetracycline antibiotics for four weeks prior to bone biopsy
- Any PTH analogs \[e.g., rhPTH(1-84), PTH(1-34), PTHrP and analogs\]
- Fluoride
- Strontium
- Phenytoin for seizure control
- Any investigational drug other than ALX1-11
- +36 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (132)
'The University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
'Rheumatology Associates of North Alabama
Huntsville, Alabama, 35801, United States
'Radiant Research - Phoenix North
Phoenix, Arizona, 85013, United States
'Osteoporosis Medical Center
Beverly Hills, California, 90211, United States
'East Bay Clinical Trial Center
Concord, California, 94520, United States
'Loma Linda Osteoporosis Research Center
Loma Linda, California, 92354, United States
Foundation for Osteoporosis Research
Oakland, California, 94612, United States
'Desert Medical Advances
Palm Desert, California, 92260, United States
'VA Palo Alto Health Care System
Palo Alto, California, 94304, United States
'Boling Clinical Trials
Rancho Cucamonga, California, 91730, United States
'S.D. Arthritis & Osteoporosis Medical Clinic
San Diego, California, 92120, United States
'Radiant Research - San Diego
San Diego, California, 92123, United States
'San Francisco General Hospital
San Francisco, California, 94110, United States
'Longmont Medical Research Network
Longmont, Colorado, 80501, United States
'Northeast Clinical Research, LLC
Hamden, Connecticut, 06518, United States
'RASF - Clinical Research Center
Boca Raton, Florida, 33486, United States
'The Center for Diabetes and Endocrine Care
Hollywood, Florida, 33021, United States
'Florida Wellcare Alliance
Inverness, Florida, 34452, United States
'Renstar Medical Group
Ocala, Florida, 34471, United States
'The Arthritis Center
Palm Harbor, Florida, 34684, United States
'The Centre for Arthritis and Rheumatic Diseases
South Miami, Florida, 33143, United States
'Radiant Research - Stuart & LakeWorth
Stuart, Florida, 34996, United States
'Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
'Radiant Research
Honolulu, Hawaii, 96814, United States
'Intermountain Orthopaedics
Boise, Idaho, 83702, United States
Rush-Prebyterian-St.Luke's Medical Center
Chicago, Illinois, 60612, United States
'The University of Chicago
Chicago, Illinois, 60637, United States
'University Hospital & Outpatient Center
Indianapolis, Indiana, 46202, United States
'Mercy Arthritis and Osteoporosis Center
Des Moines, Iowa, 50322, United States
'Wichita Clinic
Wichita, Kansas, 67208, United States
'Ochsner Clinic
New Orleans, Louisiana, 70121, United States
'Maine Center for Osteoporosis Research & Education
Bangor, Maine, 04401, United States
'Bethesda Health Research Center
Bethesda, Maryland, 20817, United States
'The Osteoporosis and Clinical Trials Center
Cumberland, Maryland, 21502, United States
'Arthritis & Osteoporosis Center of Maryland
Frederick, Maryland, 21702, United States
'The Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902, United States
'Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
'Michigan Bone & Mineral Clinic
Detroit, Michigan, 48236, United States
'Desoto Family Medical Center
Olive Branch, Mississippi, 38654, United States
'St. John's Medical Research Group
Springfield, Missouri, 65807, United States
'Arthritis, Osteoporosis Muscle Skeletal Disease Center
Concord, New Hampshire, 03301, United States
'Anderson and Collins Clinical Research Inc.
South Plainfield, New Jersey, 07080, United States
'New Mexico Clinical Research and Osteoporosis Center
Albuquerque, New Mexico, 87106, United States
'Lovelace Scientific Resources
Albuquerque, New Mexico, 87108, United States
'College of Physicians and Surgeons, Columbia University
New York, New York, 10032, United States
'Rochester Clinical Research Inc.
Rochester, New York, 14609, United States
'Stony Brook Clinical Research Trials Center
Stony Brook, New York, 11794, United States
'Physicians Clinical Research Services
White Plains, New York, 10605, United States
'Duke University Medical Center
Durham, North Carolina, 27710, United States
'Odyssey Research Services
Bismarck, North Dakota, 58501, United States
Michael J. Lillestol
Fargo, North Dakota, 58103, United States
'Altru Health Systems / Altru Research Center
Grand Forks, North Dakota, 58201, United States
'Odyssey Research Services
Minot, North Dakota, 58701, United States
'Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
'David R. Mandel M.D. Inc.
Mayfield, Ohio, 44143, United States
'Oklahoma Center for Arthritis Therapy & Research, Inc.
Tulsa, Oklahoma, 74114, United States
'Osteoporosis Center
Medford, Oregon, 97504, United States
'Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
'Thomas Jefferson University
Philadelphia, Pennsylvania, 19131, United States
'University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
'Clinical Research Center of Reading LLP
West Reading, Pennsylvania, 19611, United States
'Radiant Research
Wyomissing, Pennsylvania, 19610, United States
'Rhode Island Hospital
Providence, Rhode Island, 02903, United States
'Roger Williams Medical Center
Providence, Rhode Island, 02908, United States
'Radiant Research
Anderson, South Carolina, 29621, United States
'Columbia Arthritis Center, PA
Columbia, South Carolina, 29204, United States
'Radiant Research
Greer, South Carolina, 29651, United States
'Rapid City Medical Center
Rapid City, South Dakota, 57701, United States
'Averna Research Institute
Sioux Falls, South Dakota, 57105, United States
'Brown Clinic
Watertown, South Dakota, 57201, United States
'Clinsearch
Chattanooga, Tennessee, 37404, United States
'Radiant Research/Dallas
Dallas, Texas, 75235, United States
'Breco Research Inc.
Houston, Texas, 77024, United States
'Diabetes Center of the Southwest
Midland, Texas, 79705, United States
'Diabetes & Glandular Disease Research Associates, P.A.
San Antonio, Texas, 78229, United States
'Radiant Research San Antonio
San Antonio, Texas, 78229, United States
'Salt Lake Women's Center
Sandy City, Utah, 84070, United States
'Fletcher Allan Health Center, UHC Campus 1
Burlington, Vermont, 05401, United States
'Center for Arthritis and Diabetes
Newport News, Virginia, 23606, United States
'National Clinical Research, Inc.
Richmond, Virginia, 23294, United States
'MCV Physicians Program for Osteoporosis
Richmond, Virginia, 23298, United States
'Osteoporosis Research Group
Seattle, Washington, 98105, United States
'University of Wisconsin Medical Foundation
Madison, Wisconsin, 53792, United States
'Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
'IDIM
Buenos Aires, BUE, C1012AAR, Argentina
'Centro Médico T.I.E.M.P.O
Buenos Aires, BUE, C1117ABH, Argentina
'Hospital Ramos Mejía
Buenos Aires, BUE, C1221ADC, Argentina
'Centro de Osteopatias Medicas
Capital Federal, CBA, C1114AAI, Argentina
'Universidade Federal do Paraná
Curitiba, Paraná, 80060, Brazil
'Hospital Santa Casa de Misericórdia do Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, 20020, Brazil
'Hospital do Servidor Público do Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, 20221, Brazil
'Universidade Federal de São Paulo
São Paulo, São Paulo, 04038, Brazil
'Instituto de Saúde e Bem Estar da Mulher
São Paulo, São Paulo, 04062, Brazil
'Hospital Heliópolis
São Paulo, São Paulo, 04231, Brazil
'Heritage Medical Research Clinic
Calgary, Alberta, 'T2N 4N1, Canada
Osteoporosis Research Center
Vancouver, British Columbia, V5Z 2N6, Canada
'Manitoba Clinic
Winnipeg, Manitoba, 'R3A 1M3, Canada
Charlton medical Centre
Hamilton, Ontario, L8N 1Y2, Canada
Rafat Faraawi
Kitchener, Ontario, N2M 5N6, Canada
'Centre for Activity and Aging
London, Ontario, 'N6G 2M3, Canada
St. Joseph's Health Centre
London, Ontario, N6A 4V2, Canada
'Royal Victoria Hospital
Montreal, Ontario, 'H3A 1A1, Canada
Oakville Bone Center
Oakville, Ontario, L6J 1X8, Canada
Ottawa Hospital
Ottawa, Ontario, 'K1H 8L6, Canada
'Sunnybrook and Women's College Health Science Center
Toronto, Ontario, 'M4N 3M5, Canada
'St. Michael's Hospital
Toronto, Ontario, 'M5C 2T2, Canada
'Osteoporosis Research Program
Toronto, Ontario, 'M5S 1B2, Canada
Jude F. Rodrigues
Windsor, Ontario, N8W 5L7, Canada
'Riverside Medical Centre
Charlottetown, Prince Edward Island, C1A 6A4, Canada
'Complexe Hospitalier de la Sagami
Chicoutimi, Quebec, G7H 5H6, Canada
'Hopital Maisonneuve-Rosemont
Montreal, Quebec, 'H1T 2M4, Canada
'Centre de Recherche du CHUM - Hopital Saint-Luc
Montreal, Quebec, 'H2X 1P1, Canada
Centre de recherche - CORQ
Sainte-Foy, Quebec, G1V 3M7, Canada
Novabyss Research Clinic
Sherbrooke, Quebec, J1J 2B8, Canada
'Saskatoon Osteoporosis Centre
Saskatoon, Saskatchewan, 'S7K 0H6, Canada
'Soroka Medical Center
Beersheba, 84101, Israel
'Rambam Medical Center
Haifa, 31096, Israel
'Lin Medical Center
Haifa, 34162, Israel
'Hadassah University Hospital
Jerusalem, 91240, Israel
'Chaim Sheba Medical Center
Ramat Gan, 52621, Israel
'Lis Maternity Hospital
Tel Aviv, Israel
'Hospital Angeles de las Lomas
Huixquilucan, EMEX, 52763, Mexico
'Hospital Aranda de la Parra
León, Guanajuato, 37000, Mexico
'OPD Hospital Civil de Guadalajara Dr. Juan I. Menchaca
Guadalajara, Jalisco, 44340, Mexico
'Hospital Civil de Belem
Guadalajara, Jalisco, 44650, Mexico
'Medica Monraz
Guadalajara, Jalisco, 44670, Mexico
'Instituto Mexicano de Investigacion Clinica
Mexico City, Mexico City, 06700, Mexico
'Hospital de Mexico
Mexico City, Mexico City, 11800, Mexico
'Hospital Universitario de Monterrey
Monterrey Nuevo Leon, 64040, Mexico
'Spitalul Clinic Judetean Cluj-Napoca
Cluj-Napoca, 3400, Romania
'Scientific Center of Endocrinology of RAMS
Moscow, 117036, Russia
'Russian Academy for Advanced Medical Studies
Moscow, 125315, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 15, 2005
Study Start
October 16, 2001
Primary Completion
April 13, 2005
Study Completion
April 13, 2005
Last Updated
May 17, 2021
Record last verified: 2021-05