At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 64 enrolled
Drug / intervention
denosumabdrug
Likely dose
denosumab 60 mgfrom 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.
Uncemented Total Hip Implant and Subcutaneous Injections of Denosumab for Patients With Osteoarthritis of the Hip. A Randomized Double Blind Placebo Controlled Study on the Effects on Bone Evaluated With DXA, PET/CT and Biochemical Markers
In Brief
A Phase 2 clinical trial evaluating denosumab for Osteoarthritis, Hip and Ambulation Difficulty. Completed, enrolled 64 participants across 1 site.
Detailed Summary
The primary objective is to study the effect of Denosumab on Bone Mineral Density, Standardised Uptake Value and bone metabolism in patients with total hip arthroplasty. The primary hypothesis is to demonstrate that Denosumab is superior to placebo.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis, Hip, Ambulation Difficulty
CountriesSweden
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 2012
Enrollment StartAug 2012
Primary CompletionJan 2017
Study CompletionMar 2017
TodayJul 2026
First PostedJun 28, 2012
Enrollment StartAug 7, 2012
Primary CompletionJan 16, 2017
Study CompletionMar 30, 2017
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 14.0 years ago
Interventions
denosumabdrug
Two doses of 60 mg in a solution of 1 ml, given as an subcutaneous injection with a 6 month interval