Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1683 participants
INTERVENTIONAL
2001-10-16
2005-04-13
Brief Summary
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Detailed Description
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The primary objective of this OLES 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. A secondary objective is to assess the change in vertebral BMD and compare the changes observed in patients who received ALX1-11 or placebo in Protocol ALX1-11-93001.
Patients will receive 100 µg/day of ALX1-11 daily via subcutaneous injection in this study. Patients should continue the study drug dosing frequency they were following at the end of Protocol ALX1-11-93001.
To enhance their safety, all patients will continue to take their daily supplements of 700 mg calcium and 400 IU Vitamin D3 prior to and during this OLES. Patients whose calcium supplement was discontinued during Protocol ALX1-11-93001 should maintain that discontinuation during this OLES. However upon completion of ALX1-11 dosing in the OLES, oral calcium supplement at a dose of 700 mg each morning should be restarted and maintained for the remainder of the OLES. Additional supplemental calcium and/or Vitamin D3 will not be permitted. A daily multivitamin supplement may be taken during the study. However, the multivitamin must contain no more than 200 mg/day calcium and 400 IU/day Vitamin D3. Patients will be monitored for the development of hypercalcemia and/or hypercalciuria and managed as described in Appendices 4 and 5.
There will be a stopping rule in this OLES. Any patient who reaches a BMD T score of -0.5 or above, at the site or sites (vertebral, total hip, or femoral neck) that were used in the qualification of the patient for Protocol ALX1 11-93001, will stop ALX1-11 treatment. The patient must continue on calcium and Vitamin D3 and be followed for the remainder of this 18-month OLES. At the time of discontinuation, the patient must complete the Month 18 evaluations (Appendix 1A or 1B).
The Clinical Advisory Board (CAB) used in Protocol ALX1-11-93001 will be involved in reviewing any patient issues that arise in this OLES. This group will provide not only continuity of care for all the patients, but also enhanced and consistent safety monitoring for patients participating in the OLES.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
All patients entering the study will receive 100mcg daily for up to 6 months, making their total exposure 24 months
ALX1-11 (drug)
100 mcg PTH(1-84) injected subcutaneously daily in either the thrigh and abdomen.
Interventions
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ALX1-11 (drug)
100 mcg PTH(1-84) injected subcutaneously daily in either the thrigh and abdomen.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Development of an exclusion criterion in Protocol ALX1-11-93001
* 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.
Exclusion Criteria
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:
1. The lesion(s) were fully resected with clear margins described in a written report by a pathologist, and
2. 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
* Anabolic steroids or androgens
* Active Vitamin D3 metabolites and analogs, e.g., calcitriol
* Systemic corticosteroids, more than 5 mg/day prednisone or a systemic corticosteroid formulation equivalent to 5 mg/day prednisone
1\. A patient who has been enrolled into the OLES and needs to receive an acute bolus of steroids (oral or injectable) for a self-limited illness may continue treatment in the study if the following requirements are met:
1. Exposure to steroids will be limited to no more than 30 consecutive days
2. The maximal dose of steroid (prednisone equivalent) must be limited to no more than 225 mg (7.5 mg each day for 30 days)
3. The illness is acute in nature and is not expected to recur during the remaining period of the study
* Bisphosphonates, including investigational bisphosphonates
* Calcitonin
* Estrogen replacement therapy by oral, transdermal or intramuscular administration
* SERM drugs, e.g., tamoxifen, raloxifene, Evista
* Vaginal application of estrogen-containing creams unless the dose is:
1. conjugated estrogen or estradiol: maximum of 0.5 g twice each week (total of 1.0 g weekly)
2. Estrace (Ogen): maximum of 1.0 g twice each week (total of 2.0 g weekly)
* Daily inhaled corticosteroid unless dose is equivalent to \<1200 µg/day of beclomethasone
* Cytostatics, e.g., azathioprine, recombinant human tumor necrosis fusion (Fc) protein, monoclonal antibody against tumor necrosis factor (e.g., remicade \[infliximab\]
* Methotrexate
1. The antimetabolite, methotrexate, which interferes with DNA synthesis, repair and cellular replication should not be used by patients participating in this OLES.
* In general, immunomodulatory agents with antiproliferative activity are not permitted as a concomitant medication in this OLES.
* Intra-articular injections
1\. Patients may receive a maximum of one intra-articular injection (ONE JOINT ONLY) every 6 months while participating in this OLES. The joint that is injected may be a different joint every 6 months. The dose of corticosteroid injected should not exceed the anti-inflammatory equivalent dose of Prednisone 40 mg suspension. The dose and volume should be adjusted downward as appropriate to the size of the joint.
* Provera is an acceptable concomitant medication when used according to the label instructions
Patients may be enrolled in this OLES if they have been stabilized on the following therapy for the specified amount of time:
* Thyroid Hormone (\<0.1 mg/day thyroxine) therapy for at least 6 months If taking \> 0.1 mg/day but \< 0.2 mg/day, must have serum TSH level 1. \> 0.1mU/L. Patients will be excluded if they are taking doses of \> 0.2 mg/day.
2\. However, if a patient has had a minimal change in L-thyroxine dose of \< 0.025 mg/day within 6 months of the baseline visit, and has been on this new dose for at least 2 months, the patient may be enrolled in this study. The patient's history with L-thyroxine must be clearly documented in the source documents.
3\. If a patient requires an increase in their thyroid replacement dose, as recommended by a physician who is caring for the patient, after enrollment in this OLES, the patient must have a TSH and T4 level within 3 months of the dose change to ensure the patient does not become hyperthyroid
* Stable dosage of thiazide for at least 3 consecutive months
C. Laboratory Values and Physical Examination Findings:
\- Serum calcium greater than 10.7 mg/dL (2.66 mmol/L) at baseline will be managed as outlined in Appendix 4
\- Urinary calcium to creatinine ratio greater than or equal to 1 at baseline will be managed as outlined in Appendix 5
* Elevated total serum alkaline phosphates (\> 400 U/L) at baseline will be managed as outlined in Appendix 6 except as noted for Latin and South American countries.
* Any other clinically significant abnormal value as judged by the investigator
D. Substance Abuse:
Alcohol and/or drug abuse
E. Compliance:
Suspected or confirmed poor compliance in completing clinical trial evaluations and/or clinical trial required questionnaires
45 Years
FEMALE
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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'The University of Alabama at Birmingham
Birmingham, Alabama, United States
'Rheumatology Associates of North Alabama
Huntsville, Alabama, United States
'Radiant Research - Phoenix North
Phoenix, Arizona, United States
'Osteoporosis Medical Center
Beverly Hills, California, United States
'East Bay Clinical Trial Center
Concord, California, United States
'Loma Linda Osteoporosis Research Center
Loma Linda, California, United States
Foundation for Osteoporosis Research
Oakland, California, United States
'Desert Medical Advances
Palm Desert, California, United States
'VA Palo Alto Health Care System
Palo Alto, California, United States
'Boling Clinical Trials
Rancho Cucamonga, California, United States
'S.D. Arthritis & Osteoporosis Medical Clinic
San Diego, California, United States
'Radiant Research - San Diego
San Diego, California, United States
'San Francisco General Hospital
San Francisco, California, United States
'Longmont Medical Research Network
Longmont, Colorado, United States
'Northeast Clinical Research, LLC
Hamden, Connecticut, United States
'RASF - Clinical Research Center
Boca Raton, Florida, United States
'The Center for Diabetes and Endocrine Care
Hollywood, Florida, United States
'Florida Wellcare Alliance
Inverness, Florida, United States
'Renstar Medical Group
Ocala, Florida, United States
'The Arthritis Center
Palm Harbor, Florida, United States
'The Centre for Arthritis and Rheumatic Diseases
South Miami, Florida, United States
'Radiant Research - Stuart & LakeWorth
Stuart, Florida, United States
'Palm Beach Research Center
West Palm Beach, Florida, United States
'Radiant Research
Honolulu, Hawaii, United States
'Intermountain Orthopaedics
Boise, Idaho, United States
Rush-Prebyterian-St.Luke's Medical Center
Chicago, Illinois, United States
'The University of Chicago
Chicago, Illinois, United States
'University Hospital & Outpatient Center
Indianapolis, Indiana, United States
'Mercy Arthritis and Osteoporosis Center
Des Moines, Iowa, United States
'Wichita Clinic
Wichita, Kansas, United States
'Ochsner Clinic
New Orleans, Louisiana, United States
'Maine Center for Osteoporosis Research & Education
Bangor, Maine, United States
'Bethesda Health Research Center
Bethesda, Maryland, United States
'The Osteoporosis and Clinical Trials Center
Cumberland, Maryland, United States
'Arthritis & Osteoporosis Center of Maryland
Frederick, Maryland, United States
'The Center for Rheumatology and Bone Research
Wheaton, Maryland, United States
'Brigham & Women's Hospital
Boston, Massachusetts, United States
'Michigan Bone & Mineral Clinic
Detroit, Michigan, United States
'Desoto Family Medical Center
Olive Branch, Mississippi, United States
'St. John's Medical Research Group
Springfield, Missouri, United States
'Arthritis, Osteoporosis Muscle Skeletal Disease Center
Concord, New Hampshire, United States
'Anderson and Collins Clinical Research Inc.
South Plainfield, New Jersey, United States
'New Mexico Clinical Research and Osteoporosis Center
Albuquerque, New Mexico, United States
'Lovelace Scientific Resources
Albuquerque, New Mexico, United States
'College of Physicians and Surgeons, Columbia University
New York, New York, United States
'Rochester Clinical Research Inc.
Rochester, New York, United States
'Stony Brook Clinical Research Trials Center
Stony Brook, New York, United States
'Physicians Clinical Research Services
White Plains, New York, United States
'Duke University Medical Center
Durham, North Carolina, United States
'Odyssey Research Services
Bismarck, North Dakota, United States
Michael J. Lillestol
Fargo, North Dakota, United States
'Altru Health Systems / Altru Research Center
Grand Forks, North Dakota, United States
'Odyssey Research Services
Minot, North Dakota, United States
'Cleveland Clinic Foundation
Cleveland, Ohio, United States
'David R. Mandel M.D. Inc.
Mayfield, Ohio, United States
'Oklahoma Center for Arthritis Therapy & Research, Inc.
Tulsa, Oklahoma, United States
'Osteoporosis Center
Medford, Oregon, United States
'Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
'Thomas Jefferson University
Philadelphia, Pennsylvania, United States
'University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
'Clinical Research Center of Reading LLP
West Reading, Pennsylvania, United States
'Radiant Research
Wyomissing, Pennsylvania, United States
'Rhode Island Hospital
Providence, Rhode Island, United States
'Roger Williams Medical Center
Providence, Rhode Island, United States
'Radiant Research
Anderson, South Carolina, United States
'Columbia Arthritis Center, PA
Columbia, South Carolina, United States
'Radiant Research
Greer, South Carolina, United States
'Rapid City Medical Center
Rapid City, South Dakota, United States
'Averna Research Institute
Sioux Falls, South Dakota, United States
'Brown Clinic
Watertown, South Dakota, United States
'Clinsearch
Chattanooga, Tennessee, United States
'Radiant Research/Dallas
Dallas, Texas, United States
'Breco Research Inc.
Houston, Texas, United States
'Diabetes Center of the Southwest
Midland, Texas, United States
'Diabetes & Glandular Disease Research Associates, P.A.
San Antonio, Texas, United States
'Radiant Research San Antonio
San Antonio, Texas, United States
'Salt Lake Women's Center
Sandy City, Utah, United States
'Fletcher Allan Health Center, UHC Campus 1
Burlington, Vermont, United States
'Center for Arthritis and Diabetes
Newport News, Virginia, United States
'National Clinical Research, Inc.
Richmond, Virginia, United States
'MCV Physicians Program for Osteoporosis
Richmond, Virginia, United States
'Osteoporosis Research Group
Seattle, Washington, United States
'University of Wisconsin Medical Foundation
Madison, Wisconsin, United States
'Medical College of Wisconsin
Milwaukee, Wisconsin, United States
'IDIM
Buenos Aires, BUE, Argentina
'Centro Médico T.I.E.M.P.O
Buenos Aires, BUE, Argentina
'Hospital Ramos Mejía
Buenos Aires, BUE, Argentina
'Centro de Osteopatias Medicas
Capital Federal, CBA, Argentina
'Universidade Federal do Paraná
Curitiba, Paraná, Brazil
'Hospital Santa Casa de Misericórdia do Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, Brazil
'Hospital do Servidor Público do Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, Brazil
'Universidade Federal de São Paulo
São Paulo, São Paulo, Brazil
'Instituto de Saúde e Bem Estar da Mulher
São Paulo, São Paulo, Brazil
'Hospital Heliópolis
São Paulo, São Paulo, Brazil
'Heritage Medical Research Clinic
Calgary, Alberta, Canada
Osteoporosis Research Center
Vancouver, British Columbia, Canada
'Manitoba Clinic
Winnipeg, Manitoba, Canada
Charlton medical Centre
Hamilton, Ontario, Canada
Rafat Faraawi
Kitchener, Ontario, Canada
'Centre for Activity and Aging
London, Ontario, Canada
St. Joseph's Health Centre
London, Ontario, Canada
'Royal Victoria Hospital
Montreal, Ontario, Canada
Oakville Bone Center
Oakville, Ontario, Canada
Ottawa Hospital
Ottawa, Ontario, Canada
'Sunnybrook and Women's College Health Science Center
Toronto, Ontario, Canada
'St. Michael's Hospital
Toronto, Ontario, Canada
'Osteoporosis Research Program
Toronto, Ontario, Canada
Jude F. Rodrigues
Windsor, Ontario, Canada
'Riverside Medical Centre
Charlottetown, Prince Edward Island, Canada
'Complexe Hospitalier de la Sagami
Chicoutimi, Quebec, Canada
'Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
'Centre de Recherche du CHUM - Hopital Saint-Luc
Montreal, Quebec, Canada
Centre de recherche - CORQ
Sainte-Foy, Quebec, Canada
Novabyss Research Clinic
Sherbrooke, Quebec, Canada
'Saskatoon Osteoporosis Centre
Saskatoon, Saskatchewan, Canada
'Soroka Medical Center
Beersheba, , Israel
'Rambam Medical Center
Haifa, , Israel
'Lin Medical Center
Haifa, , Israel
'Hadassah University Hospital
Jerusalem, , Israel
'Chaim Sheba Medical Center
Ramat Gan, , Israel
'Lis Maternity Hospital
Tel Aviv, , Israel
'Hospital Angeles de las Lomas
Huixquilucan, EMEX, Mexico
'Hospital Aranda de la Parra
León, Guanajuato, Mexico
'OPD Hospital Civil de Guadalajara Dr. Juan I. Menchaca
Guadalajara, Jalisco, Mexico
'Hospital Civil de Belem
Guadalajara, Jalisco, Mexico
'Medica Monraz
Guadalajara, Jalisco, Mexico
'Instituto Mexicano de Investigacion Clinica
Mexico City, Mexico City, Mexico
'Hospital de Mexico
Mexico City, Mexico City, Mexico
'Hospital Universitario de Monterrey
Monterrey Nuevo Leon, , Mexico
'Spitalul Clinic Judetean Cluj-Napoca
Cluj-Napoca, , Romania
'Scientific Center of Endocrinology of RAMS
Moscow, , Russia
'Russian Academy for Advanced Medical Studies
Moscow, , Russia
Countries
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Other Identifiers
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CL1-11-002
Identifier Type: -
Identifier Source: org_study_id
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