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

Sheba Medical Center

Status and phase: Unknown; Phase 4

Conditions: Spinal Cord Injuries; Osteoporosis Fracture

Treatments: Drug: Romosozumab; Drug: Zoledronic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT04597931

SHEBA-20-7186-LT-CTIL

Details and patient eligibility

About

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.

Full 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)

Enrollment: 30 estimated patients

Sex: Female

Ages: 20 to 70 years old

Volunteers: No 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 %.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

SC Romosozumab 210 mg/monthly

Experimental group

Description:

SC Romosozumab 210 mg/monthly

Treatment:

Drug: Romosozumab

IV Zoledronic acid 5 mg

Active Comparator group

Description:

IV Zoledronic acid 5 mg

Treatment:

Drug: Zoledronic Acid