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

Primary Purpose

Osteoporosis Fracture, Spinal Cord Injuries

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Romosozumab
Zoledronic Acid
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis Fracture focused on measuring bone mineral density, fracture, romosozumab

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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 %.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    SC Romosozumab 210 mg/monthly

    IV Zoledronic acid 5 mg

    Arm Description

    SC Romosozumab 210 mg/monthly

    IV Zoledronic acid 5 mg

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    October 12, 2020
    Last Updated
    October 21, 2020
    Sponsor
    Sheba Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04597931
    Brief Title
    Evaluation of Romosozumab vs. Zoledronic Acid Effect in Patients With Spinal Cord Injury and Low Bone Mineral Density
    Official Title
    Evaluation of Romosozumab vs. Zoledronic Acid Effect in Patients With Spinal Cord Injury and Low Bone Mineral Density
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2020 (Anticipated)
    Primary Completion Date
    November 15, 2023 (Anticipated)
    Study Completion Date
    November 15, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sheba Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoporosis Fracture, Spinal Cord Injuries
    Keywords
    bone mineral density, fracture, romosozumab

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    open label
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    SC Romosozumab 210 mg/monthly
    Arm Type
    Experimental
    Arm Description
    SC Romosozumab 210 mg/monthly
    Arm Title
    IV Zoledronic acid 5 mg
    Arm Type
    Active Comparator
    Arm Description
    IV Zoledronic acid 5 mg
    Intervention Type
    Drug
    Intervention Name(s)
    Romosozumab
    Intervention Description
    SC Romosozumab 210 mg/monthly
    Intervention Type
    Drug
    Intervention Name(s)
    Zoledronic Acid
    Intervention Description
    IV Zoledronic acid 5 mg
    Primary Outcome Measure Information:
    Title
    Total hip BMD change during a one-year treatment period
    Description
    BMD change
    Time Frame
    one year
    Secondary Outcome Measure Information:
    Title
    Change in Femoral neck BMD at 12 months
    Description
    BTM change
    Time Frame
    one year
    Title
    Bone turnover markers change
    Description
    Bone turnover markers change over time (3, 9 and 12 month)
    Time Frame
    one year

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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 %.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Liana Tripto-Shkolnik, MD
    Phone
    +972526334348
    Email
    TriptoShkolnik.Liana@sheba.health.gov.il
    First Name & Middle Initial & Last Name or Official Title & Degree
    Noa Konvalina
    Phone
    +97235302021
    Email
    endo.r@sheba.health.gov.il
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Liana Tripto-Shkolnik, MD
    Organizational Affiliation
    Sheba Medical Center, Tel Hashomer
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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