At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 12 enrolled
Drug / intervention
Romosozumab +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.
Effects of Romosozumab on Bone Health in Women With Spinal Cord Injury and Osteoporosis
In Brief
A Phase 2 clinical trial evaluating Romosozumab and Alendronate for Osteoporosis and 4 related conditions. Completed, enrolled 12 participants across 1 site.
Detailed Summary
This two-year open-label pilot clinical trial will evaluate the efficacy and safety of romosozumab to treat bone loss in females with chronic spinal cord injury (SCI) and osteoporosis (OP). Participants will receive monthly injections of romosozumab during the first 12 months of the study. During the second year, participants will take oral alendronate tablets on a weekly basis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis, Bone Loss, Osteopenia, Osteoporosis, Spinal Cord Injuries, Chronic Spinal Paralysis
CountriesUnited States
CollaboratorsAmgen
Timeline
Phase 2CompletedFinished
202120222023202420252026
First PostedJan 2021
Enrollment StartMar 2021
Primary CompletionJun 2024
TodayJul 2026
First PostedJan 14, 2021
Enrollment StartMar 1, 2021
Primary CompletionJun 10, 2024
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 5.5 years ago
Interventions
Romosozumabdrug
Year 1 study drug
Alendronatedrug
Year 2 study drug