COMBINATION_PRODUCT
abaloparatide-sMTS
Abaloparatide-sMTS is a drug-device combination product consisting of the drug abaloparatide coated onto an sMTS array for transdermal administration of abaloparatide.
Status
Completed
Phase
Phase 1
Enrollment
22
Locations
1
Results
Posted
Publications
1
Study summary
This was an open-label, single-center study to evaluate the usability of abaloparatide-sMTS by participants with low BMD.
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.
Interventions
COMBINATION_PRODUCT
Abaloparatide-sMTS is a drug-device combination product consisting of the drug abaloparatide coated onto an sMTS array for transdermal administration of abaloparatide.
Timeline
First posted
Apr 29, 2020
Study start
Apr 9, 2019
Primary completion
May 14, 2019
Study completion
May 14, 2019
Results posted
Nov 22, 2023
Registry updated
Nov 22, 2023
Outcomes
Abaloparatide Maximum Plasma Concentration (Cmax) on Day 29
Time frame · 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
Time frame · 0 (predose) and 4 hours postdose on Day 29
Percent Change From Baseline of Serum Procollagen Type I N-Terminal Propeptides (s-PINP) at Day 29
Time frame · Baseline, 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.
Change From Baseline of Serum Calcium (Albumin-Corrected) to Predose and Postdose on Day 29
Time frame · Baseline, 0 (predose) and 4 hours postdose on Day 29
Change From Baseline of Serum Phosphorus to Predose and Postdose on Day 29
Time frame · Baseline, 0 (predose) and 4 hours postdose on Day 29
Change From Baseline of Cyclic Adenosine Monophosphate (cAMP) to Day 29
Time frame · Baseline, 0 (predose) and 30-minutes postdose on Day 29
Eligibility
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
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Pharmaceutical Research Associates, Inc
Lenexa, Kansas, United States
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Related PeptideStat pages
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