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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04597931

Enrollment

Registered

2020-10-22

Start date

2020-11-01

Completion date

2023-11-15

Last updated

2020-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis Fracture, Spinal Cord Injuries

Keywords

bone mineral density, fracture, romosozumab

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)

Interventions

DRUGRomosozumab

SC Romosozumab 210 mg/monthly

DRUGZoledronic Acid

IV Zoledronic acid 5 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

open label

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 70 Years

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 %.

Design outcomes

Primary

Measure	Time frame	Description
Total hip BMD change during a one-year treatment period	one year	BMD change

Secondary

Measure	Time frame	Description
Change in Femoral neck BMD at 12 months	one year	BTM change
Bone turnover markers change	one year	Bone turnover markers change over time (3, 9 and 12 month)

Contacts

Primary ContactLiana Tripto-Shkolnik, MD

TriptoShkolnik.Liana@sheba.health.gov.il+972526334348

Backup ContactNoa Konvalina

endo.r@sheba.health.gov.il+97235302021

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026