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

Completed · Phase 3

Conditions studied: Postmenopausal Osteoporosis

In brief

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

Key facts

Study ID

NCT04064411

Run by

Radius Health, Inc.

People needed

511

Starts

2019-08-05

Expected to finish

2021-11-09

Last updated by the study team

2023-02-15

Who can join

Age: 50 and older, up to 85. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

• 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
• Suncoast Research Group, LLC — Miami, Florida, United States
• University of Alabama Hospital at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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