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

Phase 3

Completed

• Conditions: Postmenopausal Osteoporosis
• Interventions: Combination Product: abaloparatide solid microstructured transdermal system; Combination Product: abaloparatide

• Registration Number: NCT04064411
• Lead Sponsor: Radius Health, Inc.

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.

Study Timeline

• Study Start: 2019-08-05
• Study First Submitted: 2019-08-19
• Study First Submitted QC: 2019-08-19
• Study First Posted: 2019-08-21
• Primary Completion: 2021-10-05
• Study Completion: 2021-11-09
• Results First Submitted: 2022-11-14
• Status Verified: 2023-02
• Results First Submitted QC: 2023-02-14
• Last Update Submitted: 2023-02-14
• Results First Posted: 2023-02-15
• Last Update Posted: 2023-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 511

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
abaloparatide-sMTS	abaloparatide solid microstructured transdermal system	Abaloparatide-sMTS 300 mcg applied to the thigh for 5 minutes once daily for 12 months.
abaloparatide-SC	abaloparatide	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.

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Lumbar Spine BMD at Month 12	Baseline, Month 12	Lumbar Spine BMD was assessed by DXA scans evaluated by a central imaging laboratory.

Secondary Outcome Measures

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

Trial Locations

Locations (95)

Shrock Orthopaedic Research, LLC; 🇺🇸 Fort Lauderdale, Florida, United States

Orthopedic Physician Alaska - Rheumatology; 🇺🇸 Anchorage, Alaska, United States

Arizona Arthritis & Rheumatology Research, PLLC; 🇺🇸 Mesa, Arizona, United States

Clinical Research Consortium; 🇺🇸 Tempe, Arizona, United States

SunValley Arthritis Center Ltd.; 🇺🇸 Peoria, Arizona, United States

Osteoporosis Medical Center; 🇺🇸 Beverly Hills, California, United States

Arthritis & Rheumatism; 🇺🇸 Jonesboro, Arkansas, United States

Advanced Clinical Research (ACR) - Rancho Paseo; 🇺🇸 Banning, California, United States

Clinical Trials of St. Jude Heritage Medical Group through S; 🇺🇸 Fullerton, California, United States

Alta California Medical Group, Inc.; 🇺🇸 Simi Valley, California, United States

Allied Clinical Research; 🇺🇸 Gold River, California, United States

St. Joseph Heritage Healthcare; 🇺🇸 Mission Viejo, California, United States

Marin Endocrine Care & Research, Inc.; 🇺🇸 Greenbrae, California, United States

Northern California Institute for Bone Health Inc.; 🇺🇸 Orinda, California, United States

MedStar Georgetown University Hospital - Department of Obstetrics and Gynecology; 🇺🇸 Washington, District of Columbia, United States

Clinical Research of West Florida; 🇺🇸 Clearwater, Florida, United States

Bay Area Arthritis And Osteoporosis; 🇺🇸 Brandon, Florida, United States

UNC School of Medicine; 🇺🇸 Boca Raton, Florida, United States

Palm Springs Research Institute; 🇺🇸 Hialeah, Florida, United States

Health Awareness INC; 🇺🇸 Jupiter, Florida, United States

Clinical Physiology Associates, an AMR company; 🇺🇸 Fort Myers, Florida, United States

Sweet Hope Research Specialty; 🇺🇸 Miami Beach, Florida, United States

Lakes Research, LLC; 🇺🇸 Miami Lakes, Florida, United States

Global Health Research Center; 🇺🇸 Miami Lakes, Florida, United States

West Orange Endocrinology; 🇺🇸 Ocoee, Florida, United States

Renstar Medical Research; 🇺🇸 Ocala, Florida, United States

Integral Rheumatology & Immunology Specialist; 🇺🇸 Plantation, Florida, United States

Health Awareness, Inc.; 🇺🇸 Port Saint Lucie, Florida, United States

Center for Advanced Research & Education; 🇺🇸 Gainesville, Georgia, United States

Advanced Clinical Research (ACR) - Family Practice/General Medicine - Meridian; 🇺🇸 Boise, Idaho, United States

St. Luke's Clinic - Rheumatology; 🇺🇸 Boise, Idaho, United States

MediSphere Medical Research Center; 🇺🇸 Evansville, Indiana, United States

Northeast Iowa Medical Education Foundation; 🇺🇸 Waterloo, Iowa, United States

Premier Medical Group, PSC; 🇺🇸 Owensboro, Kentucky, United States

Othopaedic Associates of Michigan PC; 🇺🇸 Grand Rapids, Michigan, United States

New Mexico Clinical Research; 🇺🇸 Albuquerque, New Mexico, United States

The Endocrine Group; 🇺🇸 Albany, New York, United States

Long Island Regional Arthritis & Osteoporosis Care PC; 🇺🇸 Babylon, New York, United States

Physicians East, PA; 🇺🇸 Greenville, North Carolina, United States

Cape Fear Arthritis Care; 🇺🇸 Leland, North Carolina, United States

Carteret Medical Group; 🇺🇸 Morehead City, North Carolina, United States

Clinical Radiology Of Oklahoma; 🇺🇸 Edmond, Oklahoma, United States

Carolina Arthritis Associates; 🇺🇸 Wilmington, North Carolina, United States

Altoona Center for Clinical Research - Research; 🇺🇸 Duncansville, Pennsylvania, United States

PA Regional Center for Arthritis & Osteoporosis Research; 🇺🇸 Wyomissing, Pennsylvania, United States

Palmetto Clinical Research; 🇺🇸 Summerville, South Carolina, United States

Dr. James Webb & Associates; 🇺🇸 Tulsa, Oklahoma, United States

The Endocrine Clinic PC; 🇺🇸 Memphis, Tennessee, United States

Inquest Clinical Research; 🇺🇸 Baytown, Texas, United States

Advanced Clinical Research-Be Well MD; 🇺🇸 Cedar Park, Texas, United States

Valley Institute of Research - General Practice; 🇺🇸 Harlingen, Texas, United States

Valley Institute of Research; 🇺🇸 Harlingen, Texas, United States

Advanced Clinical Research (ACR) - Jordan Valley; 🇺🇸 West Jordan, Utah, United States

Western Branch Center for Women; 🇺🇸 Chesapeake, Virginia, United States

Endocrinology & Diabetes Center; 🇺🇸 Chesapeake, Virginia, United States

Puget Sound Osteoporosis Center; 🇺🇸 Renton, Washington, United States

Center for Clinical and Basic Research A/S; 🇩🇰 Vejle, Denmark

University of Wisconsin Madison; 🇺🇸 Madison, Wisconsin, United States

Arthritis Northwest Rheumatology, PLLC; 🇺🇸 Spokane, Washington, United States

Synexus Magyarország Egészségügyi Szolgáltató Kft. - Budapest; 🇭🇺 Budapest, Hungary

Synexus Magyarország Egészségügyi Szolgáltató Kft. - Gyula; 🇭🇺 Gyula, Hungary

Synexus Magyarország Egészségügyi Szolgáltató Kft. - Debrecen; 🇭🇺 Debrecen, Hungary

Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház; 🇭🇺 Nyíregyháza, Hungary

Synexus Magyarország Egészségügyi Szolgáltató Kft. - Zalaegerszeg; 🇭🇺 Zalaegerszeg, Hungary

Synexus Polska Sp. Z o.o. Oddział w Częstochowie; 🇵🇱 Częstochowa, 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 Dojrzałego Sp zo.o.; 🇵🇱 Lodz, Poland

Synexus Polska Sp. Z o.o. Oddział w Lodzi; 🇵🇱 Lodz, Poland

Synexus Polska Sp. z o.o. Oddzial w Poznaniu; 🇵🇱 Poznan, Poland

Specjalistyczny Ośrodek Medycyny Wieku Dojrzałego 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, Poland

Mindful Rheumatix & Medical Research Group; 🇵🇷 San Juan, Puerto Rico

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

The University of Chicago Medicine; 🇺🇸 Chicago, Illinois, United States

Research Institute of Dallas; 🇺🇸 Dallas, Texas, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Seattle Rheumatology Associates; 🇺🇸 Seattle, Washington, United States

Rheumatology Consultants; 🇺🇸 Cumberland, Maryland, United States

MedStar Health Center; 🇺🇸 Baltimore, Maryland, United States

Biopharma Informatic LLC; 🇺🇸 Houston, Texas, United States

Suncoast Research Group, LLC; 🇺🇸 Miami, Florida, United States

Rheumatic Wellness Institute; 🇺🇸 Miami, Florida, United States

BDA Research; 🇺🇸 Miami, Florida, United States

Center for Arthritis and Rheumatic Diseases; 🇺🇸 Miami, Florida, United States

Montana Medical Research, Inc; 🇺🇸 Missoula, Montana, United States

University of Alabama Hospital at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Lynn Institute of Denver; 🇺🇸 Aurora, Colorado, United States

Lynn Health Science Institute; 🇺🇸 Oklahoma City, Oklahoma, United States

Quality Research Inc.; 🇺🇸 San Antonio, Texas, United States

BFHC Research; 🇺🇸 San Antonio, Texas, United States

Arizona Arthritis & Rheumatology Research, PLLC - Research Center - Glendale; 🇺🇸 Glendale, Arizona, United States