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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04597931
Other study ID # SHEBA-20-7186-LT-CTIL
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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 %.

Study Design


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
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