At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 58 enrolled / 58 target
Drug / intervention
Abaloparatidedrug
Likely dose
80 mcgfrom 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.
An Open-Label Phase 2 Study of Abaloparatide to Mitigate Distal Femoral Bone Loss Following Total Knee Arthroplasty
In Brief
A Phase 4 clinical trial evaluating Abaloparatide for Osteoporosis and Arthroplasties, Knee Replacement. Completed, enrolled 58 participants across 1 site.
Detailed Summary
The investigator hypothesizes that treating osteoporotic patients with abaloparatide prior to and after total knee arthroplasty will significantly reduce the amount of bone loss.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis, Arthroplasties, Knee Replacement
CountriesUnited States
CollaboratorsRadius Health, Inc.
Timeline
Phase 4CompletedFinished
2020202120222023202420252026
First PostedNov 2019
Enrollment StartJan 2020
Primary CompletionApr 2025
TodayJul 2026
First PostedNov 18, 2019
Enrollment StartJan 10, 2020
Primary CompletionApr 3, 2025
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 6.6 years ago
Arms & Interventions
Treatment groupactive_comparator
Those with clinical osteoporosis who elect ABL treatment. ABL therapy will begin 3 months pre-TKA and continue for a total of 18 months. ABL will be administered by injection pen with dose of 80 mcg SC qDay.
Drug: Abaloparatide
Comparator groupno_intervention
Those with clinical osteopenia who receive no treatment.
Interventions
Abaloparatidedrug
18 month ABL treatment