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

NCT ID: NCT04597931

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2023-11-15

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)

Conditions

Osteoporosis Fracture; Spinal Cord Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SC Romosozumab 210 mg/monthly

SC Romosozumab 210 mg/monthly

Group Type: EXPERIMENTAL

Romosozumab

Intervention Type: DRUG

SC Romosozumab 210 mg/monthly

IV Zoledronic acid 5 mg

IV Zoledronic acid 5 mg

Group Type: ACTIVE_COMPARATOR

Zoledronic Acid

Intervention Type: DRUG

IV Zoledronic acid 5 mg

Interventions

Romosozumab

SC Romosozumab 210 mg/monthly

Intervention Type: DRUG

Zoledronic Acid

IV Zoledronic acid 5 mg

Intervention Type: DRUG

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 %.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Liana Tripto Shkolnik

Deputy Director, Division of Endocrinology, Diabetes and Metabolism

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liana Tripto-Shkolnik, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center, Tel Hashomer

Central Contacts

Liana Tripto-Shkolnik, MD

Role: CONTACT

TriptoShkolnik.Liana@sheba.health.gov.il

+972526334348

Noa Konvalina

Role: CONTACT

endo.r@sheba.health.gov.il

+97235302021

Other Identifiers

SHEBA-20-7186-LT-CTIL

Identifier Type: -

Identifier Source: org_study_id