Ignite Creation Date:
2024-05-06 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04708886
Status:
COMPLETED
Last Update Posted:
2024-07-15
First Post:
2021-01-12
Brief Title:
Romosozumab in Women With Chronic SCI
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Effects of Romosozumab on Bone Health in Women With Spinal Cord Injury and Osteoporosis
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
This is a single-site singe-arm open-label pilot study to evaluate safety and efficacy of a sequential drug treatment 12 months of romosozumab injections followed by 12 months with alendronate tablets to treat bone loss in women with chronic SCI and OP
During the first year participants will receive monthly subcutaneous injections of romosozumab 210 mg This drug works by increasing bone formation and is FDA-approved for treating OP in post-menopausal women at high risk of fracture or those who did not benefit from using other available OP treatments During the second year participants will take weekly oral alendronate 70 mg Alendronate is FDA-approved for the treatment of osteopenia and the treatment of OP in post-menopausal women and men as well as for the prevention and treatment of glucocorticoid-induced OP In this study it will be used to help maintain any increases in bone mass gained from the year of treatment with romosozumab
Twelve participants will receive the study drug treatment take daily supplements calcium and vitamin D and return to the research site for study visits over the course of two years Computerized tomography CT imaging dual-energy X-ray absorptiometry DXA imaging and serum bone markers will be collected at baseline 3 months 6 months 12 months and 24 months
During the first year participants will receive monthly subcutaneous injections of romosozumab 210 mg This drug works by increasing bone formation and is FDA-approved for treating OP in post-menopausal women at high risk of fracture or those who did not benefit from using other available OP treatments During the second year participants will take weekly oral alendronate 70 mg Alendronate is FDA-approved for the treatment of osteopenia and the treatment of OP in post-menopausal women and men as well as for the prevention and treatment of glucocorticoid-induced OP In this study it will be used to help maintain any increases in bone mass gained from the year of treatment with romosozumab
Twelve participants will receive the study drug treatment take daily supplements calcium and vitamin D and return to the research site for study visits over the course of two years Computerized tomography CT imaging dual-energy X-ray absorptiometry DXA imaging and serum bone markers will be collected at baseline 3 months 6 months 12 months and 24 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 20197268 | OTHER | Amgen Inc | None |