At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 30 enrolled
Drug / intervention
Denosumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Effects of Denosumab on the Pharmacokinetics (PK) of Midazolam, a Cytochrome P450 3A4/P-gp (CYP3A4) Substrate, in Postmenopausal Osteoporotic Women
In Brief
A Phase 1 clinical trial evaluating Denosumab and Midazolam for Postmenopausal Osteoporosis. Completed, enrolled 30 participants.
Detailed Summary
This is a multi-center, open-label, drug-drug interaction study in postmenopausal women with osteoporosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostmenopausal Osteoporosis
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2010
Enrollment StartNov 2010
Primary CompletionJul 2011
TodayJul 2026
First PostedOct 15, 2010
Enrollment StartNov 1, 2010
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 15.7 years ago
Interventions
Denosumabdrug
Eighteen (18) subjects will receive 1 fixed dose administration of denosumab.
Midazolamdrug
All subjects will receive two oral dose administrations of midazolam.