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

Postmenopausal Osteoporosis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04064411
• Other study ID #: BA058-05-021
• Status: Completed
• Phase: Phase 3
• Start date: August 5, 2019
• Est. completion date: November 9, 2021

Study information

• Verified date: February 2023
• Source: Radius Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 511
• Est. completion date: November 9, 2021
• Est. primary completion date: October 5, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporosis

Intervention

Combination Product:
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Radius Health, Inc.

Countries where clinical trial is conducted

United States,  Denmark,  Hungary,  Poland,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline, Month 12
Secondary	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.	Baseline, Month 12