Clinical trial NCT04064411: Efficacy & Safety of Abaloparatide-Solid Microstructured Transdermal System in Postmenopausal Women With Osteoporosis
Official title: A Randomized, Non-inferiority, Phase 3, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Abaloparatide-sMTS for the Treatment of Postmenopausal Women With Osteoporosis (the wearABLe Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postmenopausal Osteoporosis
Keywords: Osteoporosis
transdermal delivery
microneedle
solid microstructured transdermal system
abaloparatide-sMTS
patch
abaloparatide
fracture
bone loss
TYMLOS®
Lead sponsor: Radius Health, Inc.
Sponsor class: INDUSTRY
First posted: 2019-08-21
Enrollment: 511
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A 12-month study to compare the efficacy and safety of abaloparatide-solid microstructured transdermal system (sMTS) with abaloparatide-subcutaneous (SC).

Detailed description: This study aims to evaluate the non-inferiority of abaloparatide-sMTS 300 micrograms (mcg) compared to abaloparatide-SC 80 mcg based on lumbar spine bone mineral density (BMD) at 12 months and to evaluate the safety and tolerability of abaloparatide-sMTS in the treatment of postmenopausal women with osteoporosis.

Eligibility criteria: Inclusion Criteria:

* Healthy ambulatory female from 50 to 85 years of age (inclusive) with postmenopausal osteoporosis
* 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:

* History of more than 4 mild or moderate spine fractures or any severe fracture
* 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

Primary outcomes:
measure: Percent Change From Baseline in Lumbar Spine BMD at Month 12
timeFrame: Baseline, Month 12
Secondary outcomes:
measure: Percent Change From Baseline in Total Hip BMD at Month 12
timeFrame: Baseline, Month 12
measure: Percent Change From Baseline in Femoral Neck BMD at Month 12
timeFrame: Baseline, Month 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Hospital at Birmingham
state: Alabama
city: Anchorage
country: United States
facility: Orthopedic Physician Alaska - Rheumatology
state: Alaska
city: Glendale
country: United States
facility: Arizona Arthritis & Rheumatology Research, PLLC - Research Center - Glendale
state: Arizona
city: Mesa
country: United States
facility: Arizona Arthritis & Rheumatology Research, PLLC
state: Arizona
city: Peoria
country: United States
facility: SunValley Arthritis Center Ltd.
state: Arizona
city: Tempe
country: United States
facility: Clinical Research Consortium
state: Arizona
city: Jonesboro
country: United States
facility: Arthritis & Rheumatism
state: Arkansas
city: Banning
country: United States
facility: Advanced Clinical Research (ACR) - Rancho Paseo
state: California
city: Beverly Hills
country: United States
facility: Osteoporosis Medical Center
state: California
city: Fullerton
country: United States
facility: Clinical Trials of St. Jude Heritage Medical Group through S
state: California
city: Gold River
country: United States
facility: Allied Clinical Research
state: California
city: Greenbrae
country: United States
facility: Marin Endocrine Care & Research, Inc.
state: California
city: Mission Viejo
country: United States
facility: St. Joseph Heritage Healthcare
state: California
city: Orinda
country: United States
facility: Northern California Institute for Bone Health Inc.
state: California
city: Simi Valley
country: United States
facility: Alta California Medical Group, Inc.
state: California
city: Aurora
country: United States
facility: Lynn Institute of Denver
state: Colorado
city: Washington
country: United States
facility: MedStar Georgetown University Hospital - Department of Obstetrics and Gynecology
state: District of Columbia
city: Boca Raton
country: United States
facility: UNC School of Medicine
state: Florida
city: Brandon
country: United States
facility: Bay Area Arthritis And Osteoporosis
state: Florida
city: Clearwater
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Fort Lauderdale
country: United States
facility: Shrock Orthopaedic Research, LLC
state: Florida
city: Fort Myers
country: United States
facility: Clinical Physiology Associates, an AMR company
state: Florida
city: Hialeah
country: United States
facility: Palm Springs Research Institute
state: Florida
city: Jupiter
country: United States
facility: Health Awareness INC
state: Florida
city: Miami Beach
country: United States
facility: Sweet Hope Research Specialty
state: Florida
city: Miami Lakes
country: United States
facility: Lakes Research, LLC
state: Florida
city: Miami Lakes
country: United States
facility: Global Health Research Center
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group, LLC
state: Florida
city: Miami
country: United States
facility: Rheumatic Wellness Institute
state: Florida
city: Miami
country: United States
facility: BDA Research
state: Florida
city: Miami
country: United States
facility: Center for Arthritis and Rheumatic Diseases
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Ocoee
country: United States
facility: West Orange Endocrinology
state: Florida
city: Plantation
country: United States
facility: Integral Rheumatology & Immunology Specialist
state: Florida
city: Port Saint Lucie
country: United States
facility: Health Awareness, Inc.
state: Florida
city: Gainesville
country: United States
facility: Center for Advanced Research & Education
state: Georgia
city: Boise
country: United States
facility: Advanced Clinical Research (ACR) - Family Practice/General Medicine - Meridian
state: Idaho
city: Boise
country: United States
facility: St. Luke's Clinic - Rheumatology
state: Idaho
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago Medicine
state: Illinois
city: Evansville
country: United States
facility: MediSphere Medical Research Center
state: Indiana
city: Waterloo
country: United States
facility: Northeast Iowa Medical Education Foundation
state: Iowa
city: Owensboro
country: United States
facility: Premier Medical Group, PSC
state: Kentucky
city: Baltimore
country: United States
facility: MedStar Health Center
state: Maryland
city: Cumberland
country: United States
facility: Rheumatology Consultants
state: Maryland
city: Grand Rapids
country: United States
facility: Othopaedic Associates of Michigan PC
state: Michigan
city: Missoula
country: United States
facility: Montana Medical Research, Inc
state: Montana
city: Albuquerque
country: United States
facility: New Mexico Clinical Research
state: New Mexico
city: Albany
country: United States
facility: The Endocrine Group
state: New York
city: Babylon
country: United States
facility: Long Island Regional Arthritis & Osteoporosis Care PC
state: New York
city: Greenville
country: United States
facility: Physicians East, PA
state: North Carolina
city: Leland
country: United States
facility: Cape Fear Arthritis Care
state: North Carolina
city: Morehead City
country: United States
facility: Carteret Medical Group
state: North Carolina
city: Wilmington
country: United States
facility: Carolina Arthritis Associates
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Edmond
country: United States
facility: Clinical Radiology Of Oklahoma
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Tulsa
country: United States
facility: Dr. James Webb & Associates
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research - Research
state: Pennsylvania
city: Wyomissing
country: United States
facility: PA Regional Center for Arthritis & Osteoporosis Research
state: Pennsylvania
city: Summerville
country: United States
facility: Palmetto Clinical Research
state: South Carolina
city: Memphis
country: United States
facility: The Endocrine Clinic PC
state: Tennessee
city: Baytown
country: United States
facility: Inquest Clinical Research
state: Texas
city: Cedar Park
country: United States
facility: Advanced Clinical Research-Be Well MD
state: Texas
city: Dallas
country: United States
facility: Research Institute of Dallas
state: Texas
city: Harlingen
country: United States
facility: Valley Institute of Research - General Practice
state: Texas
city: Harlingen
country: United States
facility: Valley Institute of Research
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic LLC
state: Texas
city: San Antonio
country: United States
facility: Quality Research Inc.
state: Texas
city: San Antonio
country: United States
facility: BFHC Research
state: Texas
city: West Jordan
country: United States
facility: Advanced Clinical Research (ACR) - Jordan Valley
state: Utah
city: Chesapeake
country: United States
facility: Endocrinology & Diabetes Center
state: Virginia
city: Chesapeake
country: United States
facility: Western Branch Center for Women
state: Virginia
city: Renton
country: United States
facility: Puget Sound Osteoporosis Center
state: Washington
city: Seattle
country: United States
facility: Seattle Rheumatology Associates
state: Washington
city: Spokane
country: United States
facility: Arthritis Northwest Rheumatology, PLLC
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Madison
state: Wisconsin
city: Aalborg
country: Denmark
facility: Center for Clinical and Basic Research A/S
city: Ballerup
country: Denmark
facility: Center for Clinical and Basic Research A/S
city: Vejle
country: Denmark
facility: Center for Clinical and Basic Research A/S
city: Budapest
country: Hungary
facility: Synexus Magyarország Egészségügyi Szolgáltató Kft. - Budapest
city: Debrecen
country: Hungary
facility: Synexus Magyarország Egészségügyi Szolgáltató Kft. - Debrecen
city: Gyula
country: Hungary
facility: Synexus Magyarország Egészségügyi Szolgáltató Kft. - Gyula
city: Nyíregyháza
country: Hungary
facility: Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház
city: Zalaegerszeg
country: Hungary
facility: Synexus Magyarország Egészségügyi Szolgáltató Kft. - Zalaegerszeg
city: Częstochowa
country: Poland
facility: Synexus Polska Sp. Z o.o. Oddział w Częstochowie
city: Gdansk
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Gdansku
city: Gdynia
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Gdyni
city: Katowice
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Katowicach
city: Krakow
country: Poland
facility: Krakowskie Centrum Medyczne Sp. z o.o.
city: Lodz
country: Poland
facility: Specjalistyczny Osrodek Medycyny Wieku Dojrzałego Sp zo.o.
city: Lodz
country: Poland
facility: Synexus Polska Sp. Z o.o. Oddział w Lodzi
city: Poznan
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Poznaniu
city: Warszawa
country: Poland
facility: Specjalistyczny Ośrodek Medycyny Wieku Dojrzałego Sp. z o.o
city: Warszawa
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Warszawie
city: Wroclaw
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
city: San Juan
country: Puerto Rico
facility: Mindful Rheumatix & Medical Research Group
Study officials:
References: