Current partner codePEPTIDESDE
NCT04064411·Phase 3·INTERVENTIONAL

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

Status

Completed

Phase

Phase 3

Enrollment

511

Locations

97

Results

Posted

Publications

1

Study summary

What the protocol is testing.

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

Full 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.

Interventions

Treatment arms and agents.

COMBINATION_PRODUCT

abaloparatide

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

COMBINATION_PRODUCT

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.

Timeline

From registration to results.

  1. First posted

    Aug 21, 2019

  2. Study start

    Aug 5, 2019

  3. Primary completion

    Oct 5, 2021

  4. Study completion

    Nov 9, 2021

  5. Results posted

    Feb 15, 2023

  6. Registry updated

    Feb 15, 2023

Outcomes

What the study measures.

Primary 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.

Secondary outcomes

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

Who can take part.

Minimum age
50 Years
Maximum age
85 Years
Sex
FEMALE
Healthy volunteers
No

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

97 registered sites.

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

Related trials

More studies on Abaloparatide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.