Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT05101018
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-17
First Post:
2021-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment With Romosozumab Versus Denosumab to Improve Bone Mineral Density and Architecture in Subacute SCI
Sponsor:
James J. Peters Veterans Affairs Medical Center
Organization:
Study Overview
Official Title:
Treatment With Romosozumab Versus Denosumab to Improve Bone Mineral Density and Architecture in Subacute SCI
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of the proposed work is to determine whether administration for 12 months of romosozumab followed by 12 months of denosumab will maintain bone mass at the knee in subjects with subacute SCI compared to 24 months of denosumab administration alone.
Detailed Description:
Sublesional bone loss after acute spinal cord injury (SCI) is sudden, progressive, and dramatic. After depletion of bone mass and the loss of architectural integrity, it may be difficult, if even possible, to restore skeletal mass and strength. Romosozumab is a human monoclonal anti-sclerostin antibody bone anabolic agent that recently gained FDA approval to treat osteoporosis in postmenopausal women. This study will test the ability of romosozumab administered in FDA-approved therapeutic doses for 12 months to prevent loss of BMD to regions of interest of the lower extremities in persons with subacute SCI; attention will be focused to the knee region (distal femur), but the proximal tibia and hip regions will also be acquired and analyzed. The ability of denosumab to preserve the gains in BMD attained with romosozumab will be determined.The romosozumab + denosumab group will be compared to a group that receives 24 months of denosumab.
In persons with acute/subacute motor-compete SCI (\<6 months since SCI), the primary objectives in the intervention group are to maintain baseline values of sublesional distal femur aBMD at 12 months after single drug therapy (12 months of romosozumab) and at 24 months after sequential dual drug therapy (12 months of romosozumab followed by 12 months of denosumab). This dual drug intervention group will be compared to a group that receives denosumab for 24 months; each active drug group will be compared to a historical control (placebo) group.
In persons with acute/subacute motor-compete SCI (\<6 months since SCI), the primary objectives in the intervention group are to maintain baseline values of sublesional distal femur aBMD at 12 months after single drug therapy (12 months of romosozumab) and at 24 months after sequential dual drug therapy (12 months of romosozumab followed by 12 months of denosumab). This dual drug intervention group will be compared to a group that receives denosumab for 24 months; each active drug group will be compared to a historical control (placebo) group.
Study Oversight
Has Oversight DMC:
True
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?: