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

NCT04064411 | Completed Phase 3 Results FDA Drug

• 1 other identifier: BA058-05-021
• Study Type: interventional
• Target: 511
• Locations: 5 countries
• Sites: 97

Brief Summary

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

Conditions

Postmenopausal Osteoporosis

Keywords

Osteoporosis; transdermal delivery; microneedle; solid microstructured transdermal system; abaloparatide-sMTS; patch; abaloparatide; fracture; bone loss; TYMLOS®

Outcome Measures

Primary Outcomes (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.

  Baseline, Month 12

Secondary Outcomes (2)

• Percent Change From Baseline in Total Hip BMD at Month 12

  Baseline, Month 12

• Percent Change From Baseline in Femoral Neck BMD at Month 12

  Baseline, Month 12

Study Arms (2)

abaloparatide-SC

ACTIVE COMPARATOR

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.

Combination Product: abaloparatide

abaloparatide-sMTS

EXPERIMENTAL

Abaloparatide-sMTS 300 mcg applied to the thigh for 5 minutes once daily for 12 months.

Combination Product: abaloparatide solid microstructured transdermal system

Interventions

abaloparatide COMBINATION_PRODUCT

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

Also known as: TYMLOS®, BA058, abaloparatide-SC

abaloparatide-SC

abaloparatide solid microstructured transdermal system COMBINATION_PRODUCT

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

Also known as: BA058, abaloparatide-transdermal

abaloparatide-sMTS

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Radius Health, Inc.: lead

Study Sites (97)

University of Alabama Hospital at Birmingham

Birmingham, Alabama, 35294, United States

Location

Orthopedic Physician Alaska - Rheumatology

Anchorage, Alaska, 354800, United States

Location

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

Glendale, Arizona, 85306, United States

Location

Arizona Arthritis & Rheumatology Research, PLLC

Mesa, Arizona, 85210, United States

Location

SunValley Arthritis Center Ltd.

Peoria, Arizona, 85381, United States

Location

Clinical Research Consortium

Tempe, Arizona, 85283, United States

Location

Arthritis & Rheumatism

Jonesboro, Arkansas, 72401, United States

Location

Advanced Clinical Research (ACR) - Rancho Paseo

Banning, California, 92220, United States

Location

Osteoporosis Medical Center

Beverly Hills, California, 90211, United States

Location

Clinical Trials of St. Jude Heritage Medical Group through S

Fullerton, California, 92835, United States

Location

Allied Clinical Research

Gold River, California, 95670, United States

Location

Marin Endocrine Care & Research, Inc.

Greenbrae, California, 94904, United States

Location

St. Joseph Heritage Healthcare

Mission Viejo, California, 92691, United States

Location

Northern California Institute for Bone Health Inc.

Orinda, California, 94563, United States

Location

Alta California Medical Group, Inc.

Simi Valley, California, 93065, United States

Location

Lynn Institute of Denver

Aurora, Colorado, 80012, United States

Location

MedStar Georgetown University Hospital - Department of Obstetrics and Gynecology

Washington D.C., District of Columbia, 20007, United States

Location

UNC School of Medicine

Boca Raton, Florida, 33486, United States

Location

Bay Area Arthritis And Osteoporosis

Brandon, Florida, 33511, United States

Location

Clinical Research of West Florida

Clearwater, Florida, 33765, United States

Location

Shrock Orthopaedic Research, LLC

Fort Lauderdale, Florida, 33316, United States

Location

Clinical Physiology Associates, an AMR company

Fort Myers, Florida, 33912, United States

Location

Palm Springs Research Institute

Hialeah, Florida, 33012, United States

Location

Health Awareness INC

Jupiter, Florida, 33458, United States

Location

Suncoast Research Group, LLC

Miami, Florida, 33135, United States

Location

Rheumatic Wellness Institute

Miami, Florida, 33143, United States

Location

BDA Research

Miami, Florida, 33156, United States

Location

Center for Arthritis and Rheumatic Diseases

Miami, Florida, 33173, United States

Location

Sweet Hope Research Specialty

Miami Beach, Florida, 33140, United States

Location

Lakes Research, LLC

Miami Lakes, Florida, 33014, United States

Location

Global Health Research Center

Miami Lakes, Florida, 33016, United States

Location

Renstar Medical Research

Ocala, Florida, 34470, United States

Location

West Orange Endocrinology

Ocoee, Florida, 34761, United States

Location

Integral Rheumatology & Immunology Specialist

Plantation, Florida, 33324, United States

Location

Health Awareness, Inc.

Port Saint Lucie, Florida, 34952, United States

Location

Center for Advanced Research & Education

Gainesville, Georgia, 30501, United States

Location

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

Boise, Idaho, 83642, United States

Location

St. Luke's Clinic - Rheumatology

Boise, Idaho, 83702, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

The University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

MediSphere Medical Research Center

Evansville, Indiana, 47714, United States

Location

Northeast Iowa Medical Education Foundation

Waterloo, Iowa, 50702, United States

Location

Premier Medical Group, PSC

Owensboro, Kentucky, 42303, United States

Location

MedStar Health Center

Baltimore, Maryland, 21239, United States

Location

Rheumatology Consultants

Cumberland, Maryland, 21502, United States

Location

Othopaedic Associates of Michigan PC

Grand Rapids, Michigan, 49525, United States

Location

Montana Medical Research, Inc

Missoula, Montana, 59808, United States

Location

New Mexico Clinical Research

Albuquerque, New Mexico, 87106, United States

Location

The Endocrine Group

Albany, New York, 12206, United States

Location

Long Island Regional Arthritis & Osteoporosis Care PC

Babylon, New York, 11702, United States

Location

Physicians East, PA

Greenville, North Carolina, 27834, United States

Location

Cape Fear Arthritis Care

Leland, North Carolina, 28451, United States

Location

Carteret Medical Group

Morehead City, North Carolina, 28557, United States

Location

Carolina Arthritis Associates

Wilmington, North Carolina, 28401, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Clinical Radiology Of Oklahoma

Edmond, Oklahoma, 73034, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Dr. James Webb & Associates

Tulsa, Oklahoma, 74133, United States

Location

Altoona Center for Clinical Research - Research

Duncansville, Pennsylvania, 16635, United States

Location

PA Regional Center for Arthritis & Osteoporosis Research

Wyomissing, Pennsylvania, 19610, United States

Location

Palmetto Clinical Research

Summerville, South Carolina, 29485, United States

Location

The Endocrine Clinic PC

Memphis, Tennessee, 38119, United States

Location

Inquest Clinical Research

Baytown, Texas, 77521, United States

Location

Advanced Clinical Research-Be Well MD

Cedar Park, Texas, 78613, United States

Location

Research Institute of Dallas

Dallas, Texas, 75231, United States

Location

Valley Institute of Research - General Practice

Harlingen, Texas, 78550, United States

Location

Valley Institute of Research

Harlingen, Texas, 78550, United States

Location

Biopharma Informatic LLC

Houston, Texas, 77084, United States

Location

Quality Research Inc.

San Antonio, Texas, 78209, United States

Location

BFHC Research

San Antonio, Texas, 78249, United States

Location

Advanced Clinical Research (ACR) - Jordan Valley

West Jordan, Utah, 84088, United States

Location

Endocrinology & Diabetes Center

Chesapeake, Virginia, 23321, United States

Location

Western Branch Center for Women

Chesapeake, Virginia, 23321, United States

Location

Puget Sound Osteoporosis Center

Renton, Washington, 98057, United States

Location

Seattle Rheumatology Associates

Seattle, Washington, 98122, United States

Location

Arthritis Northwest Rheumatology, PLLC

Spokane, Washington, 99204, United States

Location

University of Wisconsin Madison

Madison, Wisconsin, 53705, United States

Location

Center for Clinical and Basic Research A/S

Aalborg, Denmark

Location

Center for Clinical and Basic Research A/S

Ballerup Municipality, Denmark

Location

Center for Clinical and Basic Research A/S

Vejle, Denmark

Location

Synexus Magyarország Egészségügyi Szolgáltató Kft. - Budapest

Budapest, Hungary

Location

Synexus Magyarország Egészségügyi Szolgáltató Kft. - Debrecen

Debrecen, Hungary

Location

Synexus Magyarország Egészségügyi Szolgáltató Kft. - Gyula

Gyula, Hungary

Location

Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház

Nyíregyháza, Hungary

Location

Synexus Magyarország Egészségügyi Szolgáltató Kft. - Zalaegerszeg

Zalaegerszeg, Hungary

Location

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

Częstochowa, Poland

Location

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

Gdansk, Poland

Location

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

Gdynia, Poland

Location

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

Katowice, Poland

Location

Krakowskie Centrum Medyczne Sp. z o.o.

Krakow, Poland

Location

Specjalistyczny Osrodek Medycyny Wieku Dojrzałego Sp zo.o.

Lodz, Poland

Location

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

Lodz, Poland

Location

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

Poznan, Poland

Location

Specjalistyczny Ośrodek Medycyny Wieku Dojrzałego Sp. z o.o

Warsaw, Poland

Location

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

Warsaw, Poland

Location

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

Wroclaw, Poland

Location

Mindful Rheumatix & Medical Research Group

San Juan, 00918, Puerto Rico

Location

Related Publications (1)

• 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.

  PMID: 37417725 DERIVED

MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Osteoporosis; Fractures, Bone; Bone Diseases, Metabolic

Interventions

abaloparatide

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Wounds and Injuries

Results Point of Contact

• Title: Clinical Operations
• Organization: Radius Health, Inc.

info@radiuspharm.com

617-551-4000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 21, 2019
• Study Start: August 5, 2019
• Primary Completion: October 5, 2021
• Study Completion: November 9, 2021
• Last Updated: February 15, 2023
• Results First Posted: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

HU (5); PR (1); PL (11); DK (3); US (77)