Conditions: Postmenopausal Osteopenia Rheumatoid Arthritis Osteoporosis
Keywords: Amgen Phase 1 Postmenopausal Osteopenia Rheumatoid Bone Mineral Density Arthritis Pharmacokinetics Osteoporosis
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 19
Healthy volunteers: no

Brief summary:
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).

Detailed description:

Arms:
arm 1: Participants received etanercept 50 mg subcutaneously once weekly for 25 weeks. On study day 8, participants were administered a single 60 mg subcutaneous injection of denosumab.

Interventions: intervention 1: Etanercept intervention 2: Denosumab
Intervention descriptions: intervention 1: Administered by subcutaneous injection once a week intervention 2: Administered by subcutaneous injection

Protocol document: