The primary objective of the study was to characterize the effects of a single dose of denosumab on the pharmacokinetics (PK) of etanercept in postmenopausal women with low bone mineral density (BMD) and rheumatoid arthritis based on area under the serum concentration-time curve (AUC) and maximum observed serum concentration (Cmax).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Administered by subcutaneous injection once a week
Administered by subcutaneous injection
Research Site
Duncansville, Pennsylvania, United States
Research Site
Dallas, Texas, United States
Area Under the Serum Concentration-time Curve From 0 to 168 Hours (AUC0-168) for Etanercept
The AUC0-168 of etanercept was measured when administered alone (assessed from day 1) and after administration with denosumab (assessed from day 22, 14 days after denosumab dosing, close to the time of the maximum observed denosumab serum concentration and corresponding to a time approximately 1 week after maximal pharmacodynamic (PD) effects of denosumab are attained).
Time frame: Day 1 and day 22; at each time point samples were taken predose and 2, 3, 4, 5, 6 and 8 days postdose.
Maximum Observed Serum Concentration (Cmax) of Etanercept
Time frame: Day 1 and day 22; at each time point samples were taken predose and 2, 3, 4, 5, 6 and 8 days postdose.
Time to Maximum Serum Concentration (Tmax) of Etanercept
Time frame: Day 1 and day 22; at each time point samples were taken predose and 2, 3, 4, 5, 6 and 8 days postdose.
Serum Denosumab Concentration
Time frame: Prior to etanercept and denosumab dose administrations, as applicable, on days 8, 22, and 29
Percent Change From Baseline in Serum C-telopeptide (sCTx) Concentrations
Time frame: Baseline (Day 8) and Days 22, 29, 85, and 176
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