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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Abaloparatide-sMTS is a drug-device combination product consisting of the drug abaloparatide coated onto an sMTS array for transdermal administration of abaloparatide.
Pharmaceutical Research Associates, Inc
Lenexa, Kansas, United States
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
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.
Time frame: Baseline, Day 29
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
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