Evaluation of Romosozumab vs. Zoledronic Acid Effect in Patients With Spinal Cord Injury and Low Bone Mineral Density

Phase 4

• Conditions: Osteoporosis Fracture; Spinal Cord Injuries
• Interventions: Drug: Romosozumab; Drug: Zoledronic Acid

• Registration Number: NCT04597931
• Lead Sponsor: Sheba Medical Center

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.

Detailed Description

This is a randomized open-label study to determine the effects of monthly romosozumab for 12 month or one-time zoledronic acid infusion on bone mineral density (BMD) and biochemical markers of bone formation and resorption, in patients with spinal cord injury (SCI) and low BMD.

Patients: Thirty women between 20-70 years of age with spinal cord injury and low bone mass (BMD T-score lower than -2.0 in at least one location: Lumbar Spine, Femoral Neck or Total Hip sites) will receive study medication.

Primary outcome:

Total hip BMD change during a one-year treatment period.

Secondary outcome:

Change in Femoral neck BMD at 12 months, Bone turnover markers change over time (3, 9 and 12 month): C-terminal telopeptide of type I collagen (CTX), N-terminal propeptide of type I procollagen (P1NP).

Study population:

Thirty women between 20-70 years of age with spinal cord injury that occurred more than 24 month ago and low bone mass (BMD T-score lower than -2.0 in at least one location: Lumbar Spine, Femoral Neck or Total Hip sites)

Study Timeline

• Status Verified: 2020-10
• Study First Submitted: 2020-10-12
• Study First Submitted QC: 2020-10-21
• Last Update Submitted: 2020-10-21
• Study First Posted: 2020-10-22
• Last Update Posted: 2020-10-22
• Study Start: 2020-11-01
• Primary Completion: 2023-11-15
• Study Completion: 2023-11-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• 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

Exclusion Criteria

• myocardial infarction (MI) or stroke within the preceding year
• high cardiovascular risk, 10 years Framingham score over 20 %.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SC Romosozumab 210 mg/monthly	Romosozumab	SC Romosozumab 210 mg/monthly
IV Zoledronic acid 5 mg	Zoledronic Acid	IV Zoledronic acid 5 mg

Primary Outcome Measures

Name	Time	Method
Total hip BMD change during a one-year treatment period	one year	BMD change

Secondary Outcome Measures

Name	Time	Method
Bone turnover markers change	one year	Bone turnover markers change over time (3, 9 and 12 month)
Change in Femoral neck BMD at 12 months	one year	BTM change