TOP: Recombinant Human Parathyroid Hormone (ALX1-11) on Fracture Incidence in Women With Postmenopausal Osteoporosis
NCT ID: NCT00172081
Last Updated: 2021-05-14
Study Results
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Basic Information
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COMPLETED
PHASE3
2532 participants
INTERVENTIONAL
2000-04-27
2003-11-07
Brief Summary
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Detailed Description
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NPS Allelix Corp. is developing ALX1-11, recombinant human parathyroid hormone (1-84), for the treatment of osteoporosis. ALX1-11 is identical to the endogenous intact 84 amino acid human hormone and will be self-administered on a daily basis by subcutaneous (sc) injection.
Currently, there is no approved therapy for osteoporosis capable of stimulating the formation of new bone of normal composition and structure. Most therapies in development are anti-catabolic and only prevent further bone loss (e.g., estrogen replacement, bisphosphonates, and calcitonins). ALX1-11 has the potential to stimulate new bone formation in osteoporotic patients, thereby increasing bone mass and preventing fractures. Patients with moderately or severely reduced bone density and a fracture would be expected to benefit from treatment, thereby improving functional status and alleviating symptoms.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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placebo
Daily subcutaneous injection into thigh or abdomen with 700 mg Calcium and 400 IU Vitamin D daily
placebo
Daily subcutaneous injection with placebo
PTH(1-84) 100 mcg
Subcutaneous injection of PTH(1-84) with 700 mg Calcium and 400 IU Vitamin D daily
ALX1-11
PTH (1-84) 100 mcg injected subcutaneously into the thigh or abdomen
Interventions
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placebo
Daily subcutaneous injection with placebo
ALX1-11
PTH (1-84) 100 mcg injected subcutaneously into the thigh or abdomen
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Women who are 45-54 years of age with the following bone mineral density (BMD) and/or vertebral fracture:
* BMD 3.0 standard deviations (SDs) or more below peak bone mass of young females at the lumbar spine, femoral neck, or total hip; or
* BMD 2.5 SDs or more below peak bone mass of young females at the lumbar spine, femoral neck or total hip with the presence of a vertebral fracture verified by the central imaging organization before the patient is enrolled into the study.
* Women 55 or more years of age with the following BMD and/or vertebral fracture:
* BMD 2.5 SDs or more below peak bone mass of young females at the lumbar spine, femoral neck or total hip; or
* BMD 2.0 SDs or more below peak bone mass of young females at the lumbar spine, femoral neck or total hip with the presence of a vertebral fracture verified by the central imaging organization before the patient is enrolled into the study.
* The following types of vertebral fractures should not be considered for patient enrollment into this trial:
* Pathological fractures due to malignant disease or infection
* Fractures due to excessive trauma sufficient to cause a fracture in young individuals with normal bone mass
* 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 clinical trial screening visit
Exclusion Criteria
* Patient has 5 or more vertebral (thoracic and lumbar) deformities
* Patient has 2 or more lumbar vertebral deformities (L1 to L4)
* Severe lumbar scoliosis (\>15 degrees) which precludes a reliable evaluation of the dual x-ray absorptiometry (DXA)
B. DXA Imaging:
* Inability to have a DXA scan performed.
C. History or Concurrent Illness:
* Disorders of immunity
* Endocrine system
* Gastrointestinal system
* Kidney and collecting system
* Liver, biliary tract and pancreatic systems
* Musculoskeletal system
* Neoplasia
* Nervous system
* Vascular, respiratory and cardiac system
* Significant diseases or disorders are determined by history, physical exam or laboratory screens and judged by the Principal Investigator to be significant.
D. Concurrent Medication:
Any patient who does not require medication washout (discontinuation) as specified below may start study drug dosing after 2 weeks of stabilization treatment with calcium and vitamin D3 supplements. All exceptions will be documented in the case report form (CRF).
* Patients cannot be enrolled into this clinical trial if they have received any of the following therapies at any time:
* Any PTH or PTH analogs \[e.g., rhPTH(1-84), PTH(1-34), PTHrP and analogs\]
* Fluoride
* Strontium
* Patients must have been off the following agents for the specified times before entering the screening phase of this clinical trial:
* Any investigational drug (30 days)
* Anabolic steroids or androgens (6 consecutive months)
* Active vitamin D3 metabolites and analogs(90 days)
* Systemic corticosteroids, more than 5 mg/day prednisone or a systemic corticosteroid formulation equivalent to 5 mg/day prednisone (12 consecutive months).
* A patient who has been enrolled in the study 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 is limited to no more than 30 consecutive days
2. The maximal dose of steroid (prednisone equivalent) is 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 treatment period of the study
* Daily inhaled corticosteroids unless dose is below 1200 mg/day of beclomethasone.
* Bisphosphonates, including investigational bisphosphonates.
* Intravenous (IV) pamidronate. Patient must be receiving pamidronate specifically to treat osteoporosis. Patient can have received only ONE IV dose of pamidronate in the 12 months immediately preceding the screening visit.
* Cyclical etidronate. Exposure to cyclical etidronate must be less than or equal to 6 months on a standard dose (e.g. 400 mg/day). Patient should not have exposure to cyclical etidronate for 9 months prior to the screening visit.
* Phenytoin for seizure control. If the patient has received phenytoin within five years of the screening visit, the patient is excluded from this study. The patient may continue in the screening process if 15 years have passed since the last dose of phenytoin at the time of the screening visit. If the phenytoin use was between 5-15 years before the screening visit and the patient received phenytoin for less than 2 months.
* Patients may be enrolled 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. \* Stable dosage of thiazide for at least 3 consecutive months.
* All patients must stop the following therapies at least 4 weeks prior to the screening visit and remain off these therapies for the remainder of the clinical trial. Screening laboratories must be performed after the washout is complete. However, imaging studies (BMD, X-rays) may be performed prior to starting the calcitonin, estrogen, and selective estrogen receptor modulation (SERM) washout.
* 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 conjugated estrogen or estradiol\* Cytostatics, e.g., azathioprine, recombinant human tumor necrosis fusion (Fc) protein, monoclonal antibody against tumor necrosis factor (e.g., remicade \[infliximab\])
* The drug class tetracyclines
* Medication known to affect the metabolism of bone (the Principal Investigator should discuss this with the Project Medical Officer before the patient is excluded from enrollment)
E. Miscellaneous Concurrent Medications:
* Methotrexate
* Intra-articular injections - Patients with chronic, active joint disease should be excluded from this Phase III study. Patients may receive a maximum of one intra-articular injection (ONE JOINT ONLY) every 6 months while participating in this Phase III study. 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.
F. Laboratory Values and Physical Examination Findings:
* Serum calcium greater than 10.7 mg/dL (2.66 mmol/L). At screening, if the serum calcium is abnormal, the patient may have the additional evaluation described below ONCE:
1. Discontinue all oral calcium and vitamin D3 supplements.
2. Repeat a fasting serum calcium level two weeks later.
3. If the fasting serum calcium level is still abnormal, the patient is discontinued from the study.
4. If the repeat fasting serum calcium is normal, the patient should have supplemental calcium and vitamin D3 restarted at the time of study drug dosing, without going through a two-week stabilization period.
* Serum creatinine \> 1.5 mg/dL (132.6 mmol/L)
* Urinary calcium to creatinine ratio is greater than or equal to 1. At screening, if a patient's urinary calcium to creatinine ratio is abnormal, the patient may have the additional evaluation described below ONCE:
1. Discontinue all oral calcium and vitamin D3 supplements.
2. Repeat a fasting urine calcium to creatinine ratio two weeks later.
3. If the fasting urinary calcium to creatinine ratio is still abnormal, the patient is discontinued from the study.
4. If the repeat fasting urinary calcium to creatinine ratio is normal, the patient should have supplemental calcium and vitamin D3 restarted at the time of study drug dosing, without going through a two-week stabilization period.
* Total serum alkaline phosphatase \>130 U/L except as noted - Argentina (311 U/L); Brazil (278 U/L); Mexico (159 U/L).
* Any other clinically significant abnormal value as judged by the investigator
* Body weight below 40 kg
G. Substance Abuse:
* Alcohol and/or drug abuse
H. Psychiatric Disease:
* Current or history of psychiatric disease that would interfere with the ability to comply with the clinical trial protocol
I. 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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Capstone Clinical Trials
Birmingham, Alabama, United States
'The University of Alabama at Birmingham
Birmingham, Alabama, United States
'Rheumatology Associates of North Alabama
Huntsville, Alabama, United States
'Radiant Research - Phoenix
Phoenix, Arizona, United States
'Robin K. Dore, M.D., Inc.
Anaheim, California, 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
'The Foundation for Osteoporosis Research and Education
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
'Radiant Research - San Diego
San Diego, California, United States
'S.D. Arthritis & Osteoporosis Medical Clinic
San Diego, California, United States
'San Francisco General Hospital
San Francisco, California, United States
'Community Research Centers
Santa Ana, California, United States
'Denver Arthritis Clinic
Denver, Colorado, United States
'Colorado Center for Bone Research
Lakewood, Colorado, United States
'Longmont Medical Research Network
Longmont, Colorado, United States
'Northeast Clinical Research, LLC
Hamden, Connecticut, United States
'Georgetown University Medical Center
Washington D.C., District of Columbia, United States
'RASF - Clinical Research Center
Boca Raton, Florida, United States
'ICSL Clinical Studies
Fort Myers, Florida, United States
'The Center for Diabetes and Endocrine Care
Hollywood, Florida, United States
'Florida Wellcare Alliance
Inverness, Florida, United States
'Radiant Research - Lake Worth
Lake Worth, Florida, United States
'Osteoporosis Center University of Miami
Miami, Florida, United States
'Renstar Medical Group
Ocala, Florida, United States
'Diabetes and Endocrinology Treatment Center
Palm Beach Gardens, Florida, United States
'The Arthritis Center
Palm Harbor, Florida, United States
'The Centre for Arthritis and Rheumatic Diseases
South Miami, Florida, United States
'ICSL Clinical Studies
St. Petersburg, Florida, United States
'Radiant Research - Stuart & LakeWorth
Stuart, Florida, United States
'Palm Beach Research Center
West Palm Beach, Florida, United States
'The Emory Clinic
Atlanta, Georgia, United States
'Radiant Research
Honolulu, Hawaii, United States
'Intermountain Orthopaedics
Boise, Idaho, United States
'ICSL-Clinical Studies
Bloomington, Illinois, 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 Osteoporosis and Clinical Trials Center
Hagerstown, Maryland, United States
'The Center for Rheumatology and Bone Research
Wheaton, Maryland, United States
'Brigham & Women's Hospital
Boston, Massachusetts, United States
'Phase III Clinical Research
Fall River, Massachusetts, United States
'Osteoporosis Research & Treatment Center
Worcester, 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
'VA Southern NV Healthcare Systems
Las Vegas, Nevada, United States
'Arthritis, Osteoporosis Muscle Skeletal Disease Center
Concord, New Hampshire, United States
'Comprehensive Clinical Research
Berlin, New Jersey, 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
'Bone Mineral Research Center
Mineola, New York, United States
'Beth Israël Medical Center
New York, New York, 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
'Carolina Bone and Joint - Charlotte
Charlotte, North Carolina, 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
'South Puget Sound Clinical Research Center
Olympia, Washington, United States
Phillip J. Mease
Seattle, Washington, 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
'Universidade Federal de Pernambuco
Recife, Pernambuco, 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
'UNICAMP
Campinas, São Paulo, Brazil
'Pontifícia Universidade Católica de Campinas
Campinas, São Paulo, Brazil
'Hospital Santa Casa de Misericórdia de São Paulo
São Paulo, São Paulo, 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
'Multifunctional Hospital for Active Treatment "Sv.Georgy"
Plovdiv, , Bulgaria
'SHATENG"Acad.Ivan Penchev"
Sofia, , Bulgaria
'Multifunctional Hospital for Active Treatment "Alexandrovska
Sofia, , Bulgaria
'Multifunctional Hospital for Active Treatment "Sv.Ivan Rilsky"
Sofia, , Bulgaria
'SHATGO"Sheynovo"
Sofia, , Bulgaria
'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
'Centre d'Etude Clinique Montreal Inc.
Montreal, 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
'Clalit Health Services
Beersheba, , Israel
'Hillel Yaffe Medical Center
Hadera, , Israel
'Rambam Medical Center
Haifa, , Israel
'Lin Medical Center
Haifa, , Israel
'Hadassah University Hospital
Jerusalem, , Israel
'Rabin Medical Center
Petah Tikva, , Israel
'Chaim Sheba Medical Center
Ramat Gan, , Israel
'Lis Maternity Hospital
Tel Aviv, , Israel
'Hospital Clinical del Parque
Chihuahua City, CHIH, Mexico
'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
'Osteosol
Mexico City, Mexico City, Mexico
'Instituto Mexicano de Investigacion Clinica
Mexico City, Mexico City, Mexico
'Hospital de Mexico
Mexico City, Mexico City, Mexico
'Hospital Central "Ignacio Morones Prieto"
San Luis Potosí City, San Luis Potosí, Mexico
'Hospital Universitario de Monterrey
Monterrey Nuevo Leon, , Mexico
'CLINTRIAL "DORIS" Medical Centre
Bucharest, , Romania
'Centrul Medical Sabyc
Bucharest, , Romania
'Spitalul Clinic Judetean Cluj-Napoca
Cluj-Napoca, , Romania
'Scientific Center of Endocrinology of RAMS
Moscow, , Russia
'JK "Medicine"
Moscow, , Russia
'Russian Academy for Advanced Medical Studies
Moscow, , Russia
Countries
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References
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Greenspan SL, Bone HG, Ettinger MP, Hanley DA, Lindsay R, Zanchetta JR, Blosch CM, Mathisen AL, Morris SA, Marriott TB; Treatment of Osteoporosis with Parathyroid Hormone Study Group. Effect of recombinant human parathyroid hormone (1-84) on vertebral fracture and bone mineral density in postmenopausal women with osteoporosis: a randomized trial. Ann Intern Med. 2007 Mar 6;146(5):326-39. doi: 10.7326/0003-4819-146-5-200703060-00005.
Other Identifiers
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ALX1-11-93001
Identifier Type: -
Identifier Source: org_study_id
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