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Postmenopausal OsteoporosisPhase 3NCT04064411

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

A Phase 3 study testing abaloparatide and abaloparatide solid microstructured transdermal system in people with Postmenopausal Osteoporosis, run by Radius Health, Inc. at 97 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 50 to 85 years, women only
Conditions the study is for
Postmenopausal Osteoporosis
What is being tested?
abaloparatide and abaloparatide solid microstructured transdermal system
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
511 participants
Where
97 sitesin 5 countries
Study dates
5 Aug 2019to 9 Nov 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

97 sites in 5 countries.

97 sites in 5 countries

United States77 sites

  • The Endocrine Group

    Albany, New York, 12206

  • New Mexico Clinical Research

    Albuquerque, New Mexico, 87106

  • Orthopedic Physician Alaska - Rheumatology

    Anchorage, Alaska, 354800

  • Lynn Institute of Denver

    Aurora, Colorado, 80012

  • Long Island Regional Arthritis & Osteoporosis Care PC

    Babylon, New York, 11702

  • MedStar Health Center

    Baltimore, Maryland, 21239

  • Advanced Clinical Research (ACR) - Rancho Paseo

    Banning, California, 92220

  • Inquest Clinical Research

    Baytown, Texas, 77521

  • Osteoporosis Medical Center

    Beverly Hills, California, 90211

  • University of Alabama Hospital at Birmingham

    Birmingham, Alabama, 35294

  • UNC School of Medicine

    Boca Raton, Florida, 33486

  • Advanced Clinical Research (ACR) - Family Practice/General Medicine - Meridian

    Boise, Idaho, 83642

  • St. Luke's Clinic - Rheumatology

    Boise, Idaho, 83702

  • Bay Area Arthritis And Osteoporosis

    Brandon, Florida, 33511

  • Advanced Clinical Research-Be Well MD

    Cedar Park, Texas, 78613

  • Endocrinology & Diabetes Center

    Chesapeake, Virginia, 23321

  • Western Branch Center for Women

    Chesapeake, Virginia, 23321

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • The University of Chicago Medicine

    Chicago, Illinois, 60637

  • Clinical Research of West Florida

    Clearwater, Florida, 33765

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Rheumatology Consultants

    Cumberland, Maryland, 21502

  • Research Institute of Dallas

    Dallas, Texas, 75231

  • Altoona Center for Clinical Research - Research

    Duncansville, Pennsylvania, 16635

  • Clinical Radiology Of Oklahoma

    Edmond, Oklahoma, 73034

  • MediSphere Medical Research Center

    Evansville, Indiana, 47714

  • Shrock Orthopaedic Research, LLC

    Fort Lauderdale, Florida, 33316

  • Clinical Physiology Associates, an AMR company

    Fort Myers, Florida, 33912

  • Clinical Trials of St. Jude Heritage Medical Group through S

    Fullerton, California, 92835

  • Center for Advanced Research & Education

    Gainesville, Georgia, 30501

  • Arizona Arthritis & Rheumatology Research, PLLC - Research Center - Glendale

    Glendale, Arizona, 85306

  • Allied Clinical Research

    Gold River, California, 95670

  • Othopaedic Associates of Michigan PC

    Grand Rapids, Michigan, 49525

  • Marin Endocrine Care & Research, Inc.

    Greenbrae, California, 94904

  • Physicians East, PA

    Greenville, North Carolina, 27834

  • Valley Institute of Research - General Practice

    Harlingen, Texas, 78550

  • Valley Institute of Research

    Harlingen, Texas, 78550

  • Palm Springs Research Institute

    Hialeah, Florida, 33012

  • Biopharma Informatic LLC

    Houston, Texas, 77084

  • Arthritis & Rheumatism

    Jonesboro, Arkansas, 72401

  • Health Awareness INC

    Jupiter, Florida, 33458

  • Cape Fear Arthritis Care

    Leland, North Carolina, 28451

  • University of Wisconsin Madison

    Madison, Wisconsin, 53705

  • The Endocrine Clinic PC

    Memphis, Tennessee, 38119

  • Arizona Arthritis & Rheumatology Research, PLLC

    Mesa, Arizona, 85210

  • Suncoast Research Group, LLC

    Miami, Florida, 33135

  • Rheumatic Wellness Institute

    Miami, Florida, 33143

  • BDA Research

    Miami, Florida, 33156

  • Center for Arthritis and Rheumatic Diseases

    Miami, Florida, 33173

  • Sweet Hope Research Specialty

    Miami Beach, Florida, 33140

  • Lakes Research, LLC

    Miami Lakes, Florida, 33014

  • Global Health Research Center

    Miami Lakes, Florida, 33016

  • St. Joseph Heritage Healthcare

    Mission Viejo, California, 92691

  • Montana Medical Research, Inc

    Missoula, Montana, 59808

  • Carteret Medical Group

    Morehead City, North Carolina, 28557

  • Renstar Medical Research

    Ocala, Florida, 34470

  • West Orange Endocrinology

    Ocoee, Florida, 34761

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Northern California Institute for Bone Health Inc.

    Orinda, California, 94563

  • Premier Medical Group, PSC

    Owensboro, Kentucky, 42303

  • SunValley Arthritis Center Ltd.

    Peoria, Arizona, 85381

  • Integral Rheumatology & Immunology Specialist

    Plantation, Florida, 33324

  • Health Awareness, Inc.

    Port Saint Lucie, Florida, 34952

  • Puget Sound Osteoporosis Center

    Renton, Washington, 98057

  • Quality Research Inc.

    San Antonio, Texas, 78209

  • BFHC Research

    San Antonio, Texas, 78249

  • Seattle Rheumatology Associates

    Seattle, Washington, 98122

  • Alta California Medical Group, Inc.

    Simi Valley, California, 93065

  • Arthritis Northwest Rheumatology, PLLC

    Spokane, Washington, 99204

  • Palmetto Clinical Research

    Summerville, South Carolina, 29485

  • Clinical Research Consortium

    Tempe, Arizona, 85283

  • Dr. James Webb & Associates

    Tulsa, Oklahoma, 74133

  • MedStar Georgetown University Hospital - Department of Obstetrics and Gynecology

    Washington D.C., District of Columbia, 20007

  • Northeast Iowa Medical Education Foundation

    Waterloo, Iowa, 50702

  • Advanced Clinical Research (ACR) - Jordan Valley

    West Jordan, Utah, 84088

  • Carolina Arthritis Associates

    Wilmington, North Carolina, 28401

  • PA Regional Center for Arthritis & Osteoporosis Research

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Poland11 sites

  • Synexus Polska Sp. Z o.o. Oddział w Częstochowie

    Częstochowa

  • Synexus Polska Sp. z o.o. Oddzial w Gdansku

    Gdansk

  • Synexus Polska Sp. z o.o. Oddzial w Gdyni

    Gdynia

  • Synexus Polska Sp. z o.o. Oddzial w Katowicach

    Katowice

  • Krakowskie Centrum Medyczne Sp. z o.o.

    Krakow

  • Specjalistyczny Osrodek Medycyny Wieku Dojrzałego Sp zo.o.

    Lodz

  • Synexus Polska Sp. Z o.o. Oddział w Lodzi

    Lodz

  • Synexus Polska Sp. z o.o. Oddzial w Poznaniu

    Poznan

  • Specjalistyczny Ośrodek Medycyny Wieku Dojrzałego Sp. z o.o

    Warsaw

  • Synexus Polska Sp. z o.o. Oddzial w Warszawie

    Warsaw

  • Synexus Polska Sp. z o.o. Oddzial we Wroclawiu

    Wroclaw

Other trials in Poland

Hungary5 sites

  • Synexus Magyarország Egészségügyi Szolgáltató Kft. - Budapest

    Budapest

  • Synexus Magyarország Egészségügyi Szolgáltató Kft. - Debrecen

    Debrecen

  • Synexus Magyarország Egészségügyi Szolgáltató Kft. - Gyula

    Gyula

  • Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház

    Nyíregyháza

  • Synexus Magyarország Egészségügyi Szolgáltató Kft. - Zalaegerszeg

    Zalaegerszeg

Other trials in Hungary

Denmark3 sites

  • Center for Clinical and Basic Research A/S

    Aalborg

  • Center for Clinical and Basic Research A/S

    Ballerup Municipality

  • Center for Clinical and Basic Research A/S

    Vejle

Other trials in Denmark

Puerto Rico1 site

  • Mindful Rheumatix & Medical Research Group

    San Juan, 00918

Other trials in Puerto Rico

About this study

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)

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

Read the 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.

Being tested
abaloparatide, abaloparatide solid microstructured transdermal system
Keywords
Osteoporosis, transdermal delivery, microneedle, solid microstructured transdermal system, abaloparatide-sMTS, patch, abaloparatide, fracture, bone loss, TYMLOS®
Medical subject headings
Osteoporosis, Postmenopausal, Osteoporosis, Fractures, Bone, Bone Diseases, Metabolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • abaloparatideCombination product

    Also called TYMLOS®, BA058, abaloparatide-SC

    Abaloparatide is a synthetic peptide that is a potent and selective activator of the parathyroid hormone 1 receptor signaling pathway.

  • abaloparatide solid microstructured transdermal systemCombination product

    Also called BA058, abaloparatide-transdermal

    Abaloparatide-sMTS is a drug-device combination product consisting of the drug abaloparatide coated onto a sMTS array for transdermal administration of abaloparatide.

Study groups in NCT04064411
Study groupRoleWhat they receive
abaloparatide-SCActive comparatorParticipants 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.
Receives: Combination Product: abaloparatide
abaloparatide-sMTSExperimentalAbaloparatide-sMTS 300 mcg applied to the thigh for 5 minutes once daily for 12 months.
Receives: Combination Product: abaloparatide solid microstructured transdermal system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change From Baseline in Lumbar Spine BMD at Month 12

    Lumbar Spine BMD was assessed by DXA scans evaluated by a central imaging laboratory.

    Measured: Baseline, Month 12

Secondary outcomes (2)

  1. Percent Change From Baseline in Total Hip BMD at Month 12

    Total hip BMD was assessed by DXA scans evaluated by a central imaging laboratory.

    Measured: Baseline, Month 12

  2. Percent Change From Baseline in Femoral Neck BMD at Month 12

    Femoral neck BMD was assessed by DXA scans evaluated by a central imaging laboratory.

    Measured: Baseline, Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2019
  2. Study start5 Aug 2019
  3. Primary completion5 Oct 2021
  4. Study completion9 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
511 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04064411
Sponsor's protocol ID
BA058-05-021
Status last verified
Feb 2023
First submitted
19 Aug 2019
Last updated
15 Feb 2023
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37417725

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing abaloparatide and abaloparatide solid microstructured transdermal system in people with Postmenopausal Osteoporosis, run by Radius Health, Inc. at 97 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 97 sites in United States, Poland, Hungary, Denmark, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Lumbar Spine BMD at Month 12 (time frame: Baseline, Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04064411, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.

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