COMBINATION_PRODUCT
abaloparatide
Abaloparatide is a synthetic peptide that is a potent and selective activator of the parathyroid hormone 1 receptor signaling pathway.
Status
Completed
Phase
Phase 3
Enrollment
511
Locations
97
Results
Posted
Publications
1
Study summary
A 12-month study to compare the efficacy and safety of abaloparatide-solid microstructured transdermal system (sMTS) with abaloparatide-subcutaneous (SC).
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.
Interventions
COMBINATION_PRODUCT
Abaloparatide is a synthetic peptide that is a potent and selective activator of the parathyroid hormone 1 receptor signaling pathway.
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.
Timeline
First posted
Aug 21, 2019
Study start
Aug 5, 2019
Primary completion
Oct 5, 2021
Study completion
Nov 9, 2021
Results posted
Feb 15, 2023
Registry updated
Feb 15, 2023
Outcomes
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.
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.
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.
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
Study locations
Denmark · Hungary · Poland · Puerto Rico · United States. Showing up to 24 locations stored in the fast local snapshot.
University of Alabama Hospital at Birmingham
Birmingham, Alabama, United States
Orthopedic Physician Alaska - Rheumatology
Anchorage, Alaska, United States
Arizona Arthritis & Rheumatology Research, PLLC - Research Center - Glendale
Glendale, Arizona, United States
Arizona Arthritis & Rheumatology Research, PLLC
Mesa, Arizona, United States
SunValley Arthritis Center Ltd.
Peoria, Arizona, United States
Clinical Research Consortium
Tempe, Arizona, United States
Arthritis & Rheumatism
Jonesboro, Arkansas, United States
Advanced Clinical Research (ACR) - Rancho Paseo
Banning, California, United States
Osteoporosis Medical Center
Beverly Hills, California, United States
Clinical Trials of St. Jude Heritage Medical Group through S
Fullerton, California, United States
Allied Clinical Research
Gold River, California, United States
Marin Endocrine Care & Research, Inc.
Greenbrae, California, United States
St. Joseph Heritage Healthcare
Mission Viejo, California, United States
Northern California Institute for Bone Health Inc.
Orinda, California, United States
Alta California Medical Group, Inc.
Simi Valley, California, United States
Lynn Institute of Denver
Aurora, Colorado, United States
MedStar Georgetown University Hospital - Department of Obstetrics and Gynecology
Washington D.C., District of Columbia, United States
UNC School of Medicine
Boca Raton, Florida, United States
Bay Area Arthritis And Osteoporosis
Brandon, Florida, United States
Clinical Research of West Florida
Clearwater, Florida, United States
Shrock Orthopaedic Research, LLC
Fort Lauderdale, Florida, United States
Clinical Physiology Associates, an AMR company
Fort Myers, Florida, United States
Palm Springs Research Institute
Hialeah, Florida, United States
Health Awareness INC
Jupiter, Florida, United States
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