Conditions: Postmenopausal Osteoporosis
Keywords: Amgen Phase 1 Postmenopausal Osteoporosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 30
Healthy volunteers: no

Brief summary:
This is a multi-center, open-label, drug-drug interaction study in postmenopausal women with osteoporosis.

Detailed description:
Approximately 27 subjects (Group A: 18; Group B: 9) will receive a 2 mg oral dose of midazolam on day 1 followed by a 24 hour PK collection. Subjects randomized to Group A will receive a single 60 mg subcutaneous (SC) dose of denosumab on day 2 administered in the abdomen. On study day 16, another 2 mg oral dose of midazolam will be administered to all subjects (Groups A and B) followed by a 24 hour PK collection. The primary analysis to determine the effect of denosumab on the PK of midazolam will be based on data from subjects in Group A only.

Arms:
arm 1: All 27 subjects will receive midazolam. arm 2: Eighteen (18) subjects will receive denosumab.

Interventions: intervention 1: Denosumab intervention 2: Midazolam
Intervention descriptions: intervention 1: Eighteen (18) subjects will receive 1 fixed dose administration of denosumab. intervention 2: All subjects will receive two oral dose administrations of midazolam.

Protocol document: