Efficacy & Safety of Abaloparatide-Solid Microstructured Transdermal System in Postmenopausal Women With Osteoporosis
NCT ID: NCT04064411
Last Updated: 2023-02-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
511 participants
INTERVENTIONAL
2019-08-05
2021-11-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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abaloparatide-SC
Participants self-administered daily doses of abaloparatide 80 mcg SC for 12 months using a single-participant, multiple-use, prefilled injection pen that delivers 30 doses. Participants received a new injection pen every 30 days.
abaloparatide
Abaloparatide is a synthetic peptide that is a potent and selective activator of the parathyroid hormone 1 receptor signaling pathway.
abaloparatide-sMTS
Abaloparatide-sMTS 300 mcg applied to the thigh for 5 minutes once daily for 12 months.
abaloparatide solid microstructured transdermal system
Abaloparatide-sMTS is a drug-device combination product consisting of the drug abaloparatide coated onto a sMTS array for transdermal administration of abaloparatide.
Interventions
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abaloparatide
Abaloparatide is a synthetic peptide that is a potent and selective activator of the parathyroid hormone 1 receptor signaling pathway.
abaloparatide solid microstructured transdermal system
Abaloparatide-sMTS is a drug-device combination product consisting of the drug abaloparatide coated onto a sMTS array for transdermal administration of abaloparatide.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants who are 50 to 65 years old with BMD T-score ≤ -2.5 and \> -5.0 at the lumbar spine or hip (femoral neck or total hip) by dual energy x-ray absorptiometry (DXA) and meet one of the following: 1) radiological evidence of 2 or more mild or one or more moderate lumbar or thoracic vertebral fractures or 2) history of fragility fracture to the forearm, humerus, sacrum, pelvis, hip, femur, or tibia within the past 5 years.
* Participants older than 65 years with BMD T score ≤ -2.0 and \> -5.0 who meet the fracture criteria may be enrolled
* Participants older than 65 years with BMD T score ≤ -3.0 and \> -5.0 at the lumbar spine or hip (femoral neck or total hip) by DXA
* Body mass index of 18.5 to 33 kilograms (kg)/square meters (m\^2), inclusive
* serum calcium (albumin-corrected), parathyroid hormone (1-84), serum phosphorus, alkaline phosphatase, and thyroid stimulating hormone within the normal reference range
* Serum 25-hydroxyvitamin D values must be ≥ 20 nanograms (ng)/milliliters (mL)
Exclusion Criteria
* Abnormality of the spine or hip that would prohibit assessment of BMD
* History of bone disorders other than postmenopausal osteoporosis or a diagnosis of cancer within the last 5 years
* History of Cushing's disease, thyroid, parathyroid, or malabsorptive syndromes or any chronic or recurrent diseases or disturbances that would interfere with the interpretation of study data or compromise the safety of the patient
* Prior treatment with parathyroid hormone, parathyroid hormone-related peptide-derived drugs, or bone anabolic steroids, including abaloparatide, teriparatide, or parathyroid hormone (1-84)
* Prior treatment with intravenous (IV) bisphosphonates at any time or oral bisphosphonates within the past 3 years; fluoride or strontium within the past 5 years; treatment with corticosteroids within the past 12 months; or selective estrogen receptor modulators within the past 6 months (except hormone replacement therapy)
* Prior treatment with an investigational drug or device within the past 90 days or 5 half-lives of the investigational drug, whichever is longer
* History of nephrolithiasis or urolithiasis within the past 5 years or hereditary disorders predisposing to osteosarcoma
50 Years
85 Years
FEMALE
No
Sponsors
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Radius Health, Inc.
INDUSTRY
Responsible Party
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Locations
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University of Alabama Hospital at Birmingham
Birmingham, Alabama, United States
Orthopedic Physician Alaska - Rheumatology
Anchorage, Alaska, United States
Arizona Arthritis & Rheumatology Research, PLLC - Research Center - Glendale
Glendale, Arizona, United States
Arizona Arthritis & Rheumatology Research, PLLC
Mesa, Arizona, United States
SunValley Arthritis Center Ltd.
Peoria, Arizona, United States
Clinical Research Consortium
Tempe, Arizona, United States
Arthritis & Rheumatism
Jonesboro, Arkansas, United States
Advanced Clinical Research (ACR) - Rancho Paseo
Banning, California, United States
Osteoporosis Medical Center
Beverly Hills, California, United States
Clinical Trials of St. Jude Heritage Medical Group through S
Fullerton, California, United States
Allied Clinical Research
Gold River, California, United States
Marin Endocrine Care & Research, Inc.
Greenbrae, California, United States
St. Joseph Heritage Healthcare
Mission Viejo, California, United States
Northern California Institute for Bone Health Inc.
Orinda, California, United States
Alta California Medical Group, Inc.
Simi Valley, California, United States
Lynn Institute of Denver
Aurora, Colorado, United States
MedStar Georgetown University Hospital - Department of Obstetrics and Gynecology
Washington D.C., District of Columbia, United States
UNC School of Medicine
Boca Raton, Florida, United States
Bay Area Arthritis And Osteoporosis
Brandon, Florida, United States
Clinical Research of West Florida
Clearwater, Florida, United States
Shrock Orthopaedic Research, LLC
Fort Lauderdale, Florida, United States
Clinical Physiology Associates, an AMR company
Fort Myers, Florida, United States
Palm Springs Research Institute
Hialeah, Florida, United States
Health Awareness INC
Jupiter, Florida, United States
Suncoast Research Group, LLC
Miami, Florida, United States
Rheumatic Wellness Institute
Miami, Florida, United States
BDA Research
Miami, Florida, United States
Center for Arthritis and Rheumatic Diseases
Miami, Florida, United States
Sweet Hope Research Specialty
Miami Beach, Florida, United States
Lakes Research, LLC
Miami Lakes, Florida, United States
Global Health Research Center
Miami Lakes, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
West Orange Endocrinology
Ocoee, Florida, United States
Integral Rheumatology & Immunology Specialist
Plantation, Florida, United States
Health Awareness, Inc.
Port Saint Lucie, Florida, United States
Center for Advanced Research & Education
Gainesville, Georgia, United States
Advanced Clinical Research (ACR) - Family Practice/General Medicine - Meridian
Boise, Idaho, United States
St. Luke's Clinic - Rheumatology
Boise, Idaho, United States
Rush University Medical Center
Chicago, Illinois, United States
The University of Chicago Medicine
Chicago, Illinois, United States
MediSphere Medical Research Center
Evansville, Indiana, United States
Northeast Iowa Medical Education Foundation
Waterloo, Iowa, United States
Premier Medical Group, PSC
Owensboro, Kentucky, United States
MedStar Health Center
Baltimore, Maryland, United States
Rheumatology Consultants
Cumberland, Maryland, United States
Othopaedic Associates of Michigan PC
Grand Rapids, Michigan, United States
Montana Medical Research, Inc
Missoula, Montana, United States
New Mexico Clinical Research
Albuquerque, New Mexico, United States
The Endocrine Group
Albany, New York, United States
Long Island Regional Arthritis & Osteoporosis Care PC
Babylon, New York, United States
Physicians East, PA
Greenville, North Carolina, United States
Cape Fear Arthritis Care
Leland, North Carolina, United States
Carteret Medical Group
Morehead City, North Carolina, United States
Carolina Arthritis Associates
Wilmington, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Clinical Radiology Of Oklahoma
Edmond, Oklahoma, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Dr. James Webb & Associates
Tulsa, Oklahoma, United States
Altoona Center for Clinical Research - Research
Duncansville, Pennsylvania, United States
PA Regional Center for Arthritis & Osteoporosis Research
Wyomissing, Pennsylvania, United States
Palmetto Clinical Research
Summerville, South Carolina, United States
The Endocrine Clinic PC
Memphis, Tennessee, United States
Inquest Clinical Research
Baytown, Texas, United States
Advanced Clinical Research-Be Well MD
Cedar Park, Texas, United States
Research Institute of Dallas
Dallas, Texas, United States
Valley Institute of Research - General Practice
Harlingen, Texas, United States
Valley Institute of Research
Harlingen, Texas, United States
Biopharma Informatic LLC
Houston, Texas, United States
Quality Research Inc.
San Antonio, Texas, United States
BFHC Research
San Antonio, Texas, United States
Advanced Clinical Research (ACR) - Jordan Valley
West Jordan, Utah, United States
Endocrinology & Diabetes Center
Chesapeake, Virginia, United States
Western Branch Center for Women
Chesapeake, Virginia, United States
Puget Sound Osteoporosis Center
Renton, Washington, United States
Seattle Rheumatology Associates
Seattle, Washington, United States
Arthritis Northwest Rheumatology, PLLC
Spokane, Washington, United States
University of Wisconsin Madison
Madison, Wisconsin, United States
Center for Clinical and Basic Research A/S
Aalborg, , Denmark
Center for Clinical and Basic Research A/S
Ballerup Municipality, , Denmark
Center for Clinical and Basic Research A/S
Vejle, , Denmark
Synexus Magyarország Egészségügyi Szolgáltató Kft. - Budapest
Budapest, , Hungary
Synexus Magyarország Egészségügyi Szolgáltató Kft. - Debrecen
Debrecen, , Hungary
Synexus Magyarország Egészségügyi Szolgáltató Kft. - Gyula
Gyula, , Hungary
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház
Nyíregyháza, , Hungary
Synexus Magyarország Egészségügyi Szolgáltató Kft. - Zalaegerszeg
Zalaegerszeg, , Hungary
Synexus Polska Sp. Z o.o. Oddział w Częstochowie
Częstochowa, , Poland
Synexus Polska Sp. z o.o. Oddzial w Gdansku
Gdansk, , Poland
Synexus Polska Sp. z o.o. Oddzial w Gdyni
Gdynia, , Poland
Synexus Polska Sp. z o.o. Oddzial w Katowicach
Katowice, , Poland
Krakowskie Centrum Medyczne Sp. z o.o.
Krakow, , Poland
Specjalistyczny Osrodek Medycyny Wieku Dojrzałego Sp zo.o.
Lodz, , Poland
Synexus Polska Sp. Z o.o. Oddział w Lodzi
Lodz, , Poland
Synexus Polska Sp. z o.o. Oddzial w Poznaniu
Poznan, , Poland
Specjalistyczny Ośrodek Medycyny Wieku Dojrzałego Sp. z o.o
Warsaw, , Poland
Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warsaw, , Poland
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
Wroclaw, , Poland
Mindful Rheumatix & Medical Research Group
San Juan, , Puerto Rico
Countries
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References
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Lewiecki EM, Czerwinski E, Recknor C, Strzelecka A, Valenzuela G, Lawrence M, Silverman S, Cardona J, Nattrass SM, Binkley N, Annett M, Pearman L, Mitlak B. Efficacy and Safety of Transdermal Abaloparatide in Postmenopausal Women with Osteoporosis: A Randomized Study. J Bone Miner Res. 2023 Oct;38(10):1404-1414. doi: 10.1002/jbmr.4877. Epub 2023 Jul 27.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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BA058-05-021
Identifier Type: -
Identifier Source: org_study_id
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