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Efficacy & Safety of Abaloparatide-Solid Microstructured Transdermal System in Postmenopausal Women With Osteoporosis | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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)

NCT04064411•Radius Health, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

50 - 85 years

Sex

FEMALE

Healthy Volunteers

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

Locations (97)

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

Key Dates

Start Date

August 5, 2019

Primary Completion Date

October 5, 2021

Completion Date

November 9, 2021

Last Updated

February 15, 2023

Enrollment

511

ACTUAL participants

Conditions

Postmenopausal Osteoporosis

Interventions

abaloparatide

COMBINATION_PRODUCT

abaloparatide solid microstructured transdermal system

COMBINATION_PRODUCT

Anabolic Therapy in Postmenopausal Osteoporosis

NCT05010590

Postmenopausal Osteoporosis

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NOT_YET_RECRUITING

AGE Burden and Response to Antiresorptive Therapy in Osteoporosis

NCT07329543

OsteoporosisPostmenopausal Osteoporosis

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WITHDRAWNNA

Feasibility of a Novel Resistance Exercise in Individuals With Osteoporosis

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 15, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Anabolic Therapy in Postmenopausal Osteoporosis

AGE Burden and Response to Antiresorptive Therapy in Osteoporosis

Feasibility of a Novel Resistance Exercise in Individuals With Osteoporosis

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