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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04597931
• Other study ID #: SHEBA-20-7186-LT-CTIL
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: November 1, 2020
• Est. completion date: November 15, 2023

Study information

• Verified date: October 2020
• Source: Sheba Medical Center
• Contact: Liana Tripto-Shkolnik, MD
• Phone: +972526334348
• Email: TriptoShkolnik.Liana[@]sheba.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: November 15, 2023
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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 %.

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis Fracture
• Osteoporotic Fractures
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Drug:
• Romosozumab
SC Romosozumab 210 mg/monthly
• Zoledronic Acid
IV Zoledronic acid 5 mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total hip BMD change during a one-year treatment period	BMD change	one year
Secondary	Change in Femoral neck BMD at 12 months	BTM change	one year
Secondary	Bone turnover markers change	Bone turnover markers change over time (3, 9 and 12 month)	one year