Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), and Usability of Abaloparatide-solid Microstructured Transdermal System (sMTS) in Postmenopausal Women With Low Bone Mineral Density (BMD)

Study Overview
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Brief Summary
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This was an open-label, single-center study to evaluate the usability of abaloparatide-sMTS by participants with low BMD.

Detailed Description
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This study aimed to evaluate the ability of participants to self-administer 300 μg abaloparatide-sMTS over a period of 29 days based on PK and PD markers.

Official Title
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A Prospective, Single Arm Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Usability of Abaloparatide-sMTS in Postmenopausal Women With Low Bone Mineral Density

Conditions
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Postmenopausal Osteoporosis

Intervention / Treatment
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* Combination Product: abaloparatide-sMTS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postmenopausal for at least 2 years BMD T-score based on the female reference range <-1.0 and >-5.0 at the lumbar spine (L1-L4) or hip (femoral neck or total hip) by dual energy X-ray absorptiometry (DXA) Good general health as determined by medical history and physical exam (including vital signs, and has a body mass index up to 33 kilograms/square meter (kg/m^2) Laboratory tests within the normal range including serum calcium (albumin-corrected), intact parathyroid hormone (PTH), serum phosphorus, alkaline phosphatase, and thyroid stimulating hormone Serum 25-hydroxyvitamin D values ≥ 20 nanograms per milliliter (ng/mL) Exclusion Criteria: History of prior external beam or implant radiation therapy involving the skeleton, other than radioiodine History of bone disorders other than postmenopausal osteoporosis (such as Paget's disease) History of cancer within the last 5 years (with the exception of basal cell or squamous cancer of the skin) History of Cushing's disease, hypo or hyperparathyroidism, or malabsorptive syndromes within the past year Prior treatment with PTH, PTH-related peptide-derived drugs, or bone anabolic steroids, including abaloparatide, teriparatide, or PTH (1-84) Prior treatment with intravenous bisphosphonates at any time or oral bisphosphonates within the past year (12 months). Participants who have received a short course of oral bisphosphonate therapy (3 months or less) may be enrolled as long as the treatment occurred 6 or more months prior to enrollment Prior treatment with an investigational drug or device within the past 3 months or 5 half-lives of the investigational drug, whichever is longer

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: abaloparatide-sMTS<br>Abaloparatide-sMTS 300 micrograms (μg) was applied to the thigh for 5 minutes once daily for 29 days. | Combination Product: abaloparatide-sMTS<br>* Abaloparatide-sMTS is a drug-device combination product consisting of the drug abaloparatide coated onto an sMTS array for transdermal administration of abaloparatide.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abaloparatide Maximum Plasma Concentration (Cmax) on Day 29 |  | 0 (predose), 10 minutes, 20 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours postdose on Day 29 | 
| Abaloparatide Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t) on Day 29 |  | 0 (predose) and 4 hours postdose on Day 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline of Serum Procollagen Type I N-Terminal Propeptides (s-PINP) at Day 29 | Blood samples were taken to measure s-PINP, a bone formation marker. s-PINP concentrations reflect the rate of skeletal new bone formation. Increases in s-PINP indicate anabolic biologic response in the bone. | Baseline, Day 29 | 
| Change From Baseline of Serum Calcium (Albumin-Corrected) to Predose and Postdose on Day 29 |  | Baseline, 0 (predose) and 4 hours postdose on Day 29 | 
| Change From Baseline of Serum Phosphorus to Predose and Postdose on Day 29 |  | Baseline, 0 (predose) and 4 hours postdose on Day 29 | 
| Change From Baseline of Cyclic Adenosine Monophosphate (cAMP) to Day 29 |  | Baseline, 0 (predose) and 30-minutes postdose on Day 29 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postmenopausal osteoporosis, transdermal delivery, microstructure patch, abaloparatide