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

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

Detailed Description
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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.

Official Title
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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)

Conditions
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Postmenopausal Osteoporosis

Intervention / Treatment
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* Combination Product: abaloparatide
* Combination Product: abaloparatide solid microstructured transdermal system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: abaloparatide-SC<br>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. | Combination Product: abaloparatide<br>* Abaloparatide is a synthetic peptide that is a potent and selective activator of the parathyroid hormone 1 receptor signaling pathway.<br>* Other names: abaloparatide-SC;|
| Experimental: abaloparatide-sMTS<br>Abaloparatide-sMTS 300 mcg applied to the thigh for 5 minutes once daily for 12 months. | Combination Product: abaloparatide solid microstructured transdermal system<br>* Abaloparatide-sMTS is a drug-device combination product consisting of the drug abaloparatide coated onto a sMTS array for transdermal administration of abaloparatide.<br>* Other names: abaloparatide-transdermal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Lumbar Spine BMD at Month 12 | Lumbar Spine BMD was assessed by DXA scans evaluated by a central imaging laboratory. | Baseline, Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Total Hip BMD at Month 12 | Total hip BMD was assessed by DXA scans evaluated by a central imaging laboratory. | Baseline, Month 12 | 
| Percent Change From Baseline in Femoral Neck BMD at Month 12 | Femoral neck BMD was assessed by DXA scans evaluated by a central imaging laboratory. | Baseline, Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoporosis, transdermal delivery, microneedle, solid microstructured transdermal system, abaloparatide-sMTS, patch, abaloparatide, fracture, bone loss, TYMLOS®