Evaluation of Romosozumab vs. Zoledronic Acid Effect in Patients With Spinal Cord Injury and Low Bone Mineral Density
1 other identifier
interventional
30
0 countries
N/A
Brief Summary
This is a randomized study to determine the effects of monthly romosozumab for one year or one-time zoledronic acid on bone mineral density (BMD) and biochemical markers of bone formation and resorption, in patients with spinal cord injury (SCI) and low BMD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Nov 2020
Typical duration for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2020
CompletedFirst Posted
Study publicly available on registry
October 22, 2020
CompletedStudy Start
First participant enrolled
November 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2023
CompletedOctober 22, 2020
October 1, 2020
3 years
October 12, 2020
October 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total hip BMD change during a one-year treatment period
BMD change
one year
Secondary Outcomes (2)
Change in Femoral neck BMD at 12 months
one year
Bone turnover markers change
one year
Study Arms (2)
SC Romosozumab 210 mg/monthly
EXPERIMENTALSC Romosozumab 210 mg/monthly
IV Zoledronic acid 5 mg
ACTIVE COMPARATORIV Zoledronic acid 5 mg
Interventions
Eligibility Criteria
You may qualify if:
- BMD T-score ≤ -2.0 at the lumbar spine, total hip or femoral neck
- SCI of at least 24-month but less than 7 years duration,
- American Spinal Injury Association (ASIA) Impairment Scale A-C
You may not qualify if:
- myocardial infarction (MI) or stroke within the preceding year
- high cardiovascular risk, 10 years Framingham score over 20 %.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Liana Tripto-Shkolnik, MD
Sheba Medical Center, Tel Hashomer
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deputy Director, Division of Endocrinology, Diabetes and Metabolism
Study Record Dates
First Submitted
October 12, 2020
First Posted
October 22, 2020
Study Start
November 1, 2020
Primary Completion
November 15, 2023
Study Completion
November 15, 2023
Last Updated
October 22, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share