Efficacy & Safety of Abaloparatide-Solid Microstructured Transdermal System in Postmenopausal Women With Osteoporosis

February 14, 2023 updated by: Radius Health, Inc.

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)

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

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

511

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Aalborg, Denmark
        • Center for Clinical and Basic Research A/S
      • Ballerup, Denmark
        • Center for Clinical and Basic Research A/S
      • Vejle, Denmark
        • Center for Clinical and Basic Research A/S
      • Budapest, Hungary
        • Synexus Magyarország Egészségügyi Szolgáltató Kft. - Budapest
      • Debrecen, Hungary
        • Synexus Magyarország Egészségügyi Szolgáltató Kft. - Debrecen
      • Gyula, Hungary
        • Synexus Magyarország Egészségügyi Szolgáltató Kft. - Gyula
      • Nyíregyháza, Hungary
        • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
      • Zalaegerszeg, Hungary
        • Synexus Magyarország Egészségügyi Szolgáltató Kft. - Zalaegerszeg
      • Częstochowa, Poland
        • Synexus Polska Sp. Z o.o. Oddział w Czestochowie
      • Gdansk, Poland
        • Synexus Polska Sp. z o.o. Oddzial w Gdansku
      • Gdynia, Poland
        • Synexus Polska Sp. z o.o. Oddzial w Gdyni
      • Katowice, Poland
        • Synexus Polska Sp. z o.o. Oddzial w Katowicach
      • Krakow, Poland
        • Krakowskie Centrum Medyczne Sp. z o.o.
      • Lodz, Poland
        • Specjalistyczny Osrodek Medycyny Wieku Dojrzałego Sp zo.o.
      • Lodz, Poland
        • Synexus Polska Sp. z o.o. Oddział w Lodzi
      • Poznan, Poland
        • Synexus Polska Sp. z o.o. Oddzial w Poznaniu
      • Warszawa, Poland
        • Synexus Polska Sp. z o.o. Oddzial w Warszawie
      • Warszawa, Poland
        • Specjalistyczny Ośrodek Medycyny Wieku Dojrzałego Sp. z o.o
      • Wroclaw, Poland
        • Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
      • San Juan, Puerto Rico, 00918
        • Mindful Rheumatix & Medical Research Group
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama Hospital at Birmingham
    • Alaska
      • Anchorage, Alaska, United States, 354800
        • Orthopedic Physician Alaska - Rheumatology
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Arizona Arthritis & Rheumatology Research, PLLC - Research Center - Glendale
      • Mesa, Arizona, United States, 85210
        • Arizona Arthritis & Rheumatology Research, PLLC
      • Peoria, Arizona, United States, 85381
        • SunValley Arthritis Center Ltd.
      • Tempe, Arizona, United States, 85283
        • Clinical Research Consortium
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Arthritis & Rheumatism
    • California
      • Banning, California, United States, 92220
        • Advanced Clinical Research (ACR) - Rancho Paseo
      • Beverly Hills, California, United States, 90211
        • Osteoporosis Medical Center
      • Fullerton, California, United States, 92835
        • Clinical Trials of St. Jude Heritage Medical Group through S
      • Gold River, California, United States, 95670
        • Allied Clinical Research
      • Greenbrae, California, United States, 94904
        • Marin Endocrine Care & Research, Inc.
      • Mission Viejo, California, United States, 92691
        • St. Joseph Heritage Healthcare
      • Orinda, California, United States, 94563
        • Northern California Institute for Bone Health Inc.
      • Simi Valley, California, United States, 93065
        • Alta California Medical Group, Inc.
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Lynn Institute of Denver
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • MedStar Georgetown University Hospital - Department of Obstetrics and Gynecology
    • Florida
      • Boca Raton, Florida, United States, 33486
        • UNC School of Medicine
      • Brandon, Florida, United States, 33511
        • Bay Area Arthritis and Osteoporosis
      • Clearwater, Florida, United States, 33765
        • Clinical Research of West Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Shrock Orthopaedic Research, LLC
      • Fort Myers, Florida, United States, 33912
        • Clinical Physiology Associates, an AMR company
      • Hialeah, Florida, United States, 33012
        • Palm Springs Research Institute
      • Jupiter, Florida, United States, 33458
        • Health Awareness INC
      • Miami, Florida, United States, 33135
        • Suncoast Research Group, LLC
      • Miami, Florida, United States, 33143
        • Rheumatic Wellness Institute
      • Miami, Florida, United States, 33156
        • BDA Research
      • Miami, Florida, United States, 33173
        • Center for Arthritis and Rheumatic Diseases
      • Miami Beach, Florida, United States, 33140
        • Sweet Hope Research Specialty
      • Miami Lakes, Florida, United States, 33014
        • Lakes Research, LLC
      • Miami Lakes, Florida, United States, 33016
        • Global Health Research Center
      • Ocala, Florida, United States, 34470
        • Renstar Medical Research
      • Ocoee, Florida, United States, 34761
        • West Orange Endocrinology
      • Plantation, Florida, United States, 33324
        • Integral Rheumatology & Immunology Specialist
      • Port Saint Lucie, Florida, United States, 34952
        • Health Awareness, Inc.
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • Center for Advanced Research & Education
    • Idaho
      • Boise, Idaho, United States, 83702
        • St. Luke's Clinic - Rheumatology
      • Boise, Idaho, United States, 83642
        • Advanced Clinical Research (ACR) - Family Practice/General Medicine - Meridian
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60637
        • The University of Chicago Medicine
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Medisphere Medical Research Center
    • Iowa
      • Waterloo, Iowa, United States, 50702
        • Northeast Iowa Medical Education Foundation
    • Kentucky
      • Owensboro, Kentucky, United States, 42303
        • Premier Medical Group, PSC
    • Maryland
      • Baltimore, Maryland, United States, 21239
        • MedStar Health Center
      • Cumberland, Maryland, United States, 21502
        • Rheumatology Consultants
    • Michigan
      • Grand Rapids, Michigan, United States, 49525
        • Othopaedic Associates of Michigan PC
    • Montana
      • Missoula, Montana, United States, 59808
        • Montana Medical Research, Inc
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • New Mexico Clinical Research
    • New York
      • Albany, New York, United States, 12206
        • The Endocrine Group
      • Babylon, New York, United States, 11702
        • Long Island Regional Arthritis & Osteoporosis Care PC
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Physicians East, PA
      • Leland, North Carolina, United States, 28451
        • Cape Fear Arthritis Care
      • Morehead City, North Carolina, United States, 28557
        • Carteret Medical Group
      • Wilmington, North Carolina, United States, 28401
        • Carolina Arthritis Associates
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Oklahoma
      • Edmond, Oklahoma, United States, 73034
        • Clinical Radiology of Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Lynn Health Science Institute
      • Tulsa, Oklahoma, United States, 74133
        • Dr. James Webb & Associates
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center for Clinical Research - Research
      • Wyomissing, Pennsylvania, United States, 19610
        • PA Regional Center for Arthritis & Osteoporosis Research
    • South Carolina
      • Summerville, South Carolina, United States, 29485
        • Palmetto Clinical Research
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • The Endocrine Clinic PC
    • Texas
      • Baytown, Texas, United States, 77521
        • Inquest Clinical Research
      • Cedar Park, Texas, United States, 78613
        • Advanced Clinical Research-Be Well MD
      • Dallas, Texas, United States, 75231
        • Research Institute Of Dallas
      • Harlingen, Texas, United States, 78550
        • Valley Institute of Research - General Practice
      • Harlingen, Texas, United States, 78550
        • Valley Institute of Research
      • Houston, Texas, United States, 77084
        • Biopharma Informatic LLC
      • San Antonio, Texas, United States, 78209
        • Quality Research Inc.
      • San Antonio, Texas, United States, 78249
        • BFHC Research
    • Utah
      • West Jordan, Utah, United States, 84088
        • Advanced Clinical Research (ACR) - Jordan Valley
    • Virginia
      • Chesapeake, Virginia, United States, 23321
        • Endocrinology & Diabetes Center
      • Chesapeake, Virginia, United States, 23321
        • Western Branch Center for Women
    • Washington
      • Renton, Washington, United States, 98057
        • Puget Sound Osteoporosis Center
      • Seattle, Washington, United States, 98122
        • Seattle Rheumatology Associates
      • Spokane, Washington, United States, 99204
        • Arthritis Northwest Rheumatology, PLLC
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin Madison

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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 is a synthetic peptide that is a potent and selective activator of the parathyroid hormone 1 receptor signaling pathway.
Other Names:
  • TYMLOS®
  • BA058
  • abaloparatide-SC
Experimental: abaloparatide-sMTS
Abaloparatide-sMTS 300 mcg applied to the thigh for 5 minutes once daily for 12 months.
Abaloparatide-sMTS is a drug-device combination product consisting of the drug abaloparatide coated onto a sMTS array for transdermal administration of abaloparatide.
Other Names:
  • BA058
  • abaloparatide-transdermal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Lumbar Spine BMD at Month 12
Time Frame: Baseline, Month 12
Lumbar Spine BMD was assessed by DXA scans evaluated by a central imaging laboratory.
Baseline, Month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Total Hip BMD at Month 12
Time Frame: Baseline, Month 12
Total hip BMD was assessed by DXA scans evaluated by a central imaging laboratory.
Baseline, Month 12
Percent Change From Baseline in Femoral Neck BMD at Month 12
Time Frame: Baseline, Month 12
Femoral neck BMD was assessed by DXA scans evaluated by a central imaging laboratory.
Baseline, Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2019

Primary Completion (Actual)

October 5, 2021

Study Completion (Actual)

November 9, 2021

Study Registration Dates

First Submitted

August 19, 2019

First Submitted That Met QC Criteria

August 19, 2019

First Posted (Actual)

August 21, 2019

Study Record Updates

Last Update Posted (Actual)

February 15, 2023

Last Update Submitted That Met QC Criteria

February 14, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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