NCT04597931 is a Phase 4 clinical trial of Romosozumab in Osteoporosis Fracture, sponsored by Sheba Medical Center.

Who is sponsoring NCT04597931?

NCT04597931 is sponsored by Sheba Medical Center.

What drugs are being tested in NCT04597931?

Interventions in NCT04597931: Romosozumab, Zoledronic Acid.

What condition does NCT04597931 study?

NCT04597931 studies Osteoporosis Fracture, Spinal Cord Injuries.

Is NCT04597931 still recruiting?

NCT04597931 is currently status unknown. Last updated 22 October 2020.

Last reviewed 2020-10-22 · How we verify

NCT04597931

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Status unknown Phase 4 Last updated 22 October 2020

What this trial tests

Phase 4 trial testing Romosozumab in Osteoporosis Fracture in 30 participants. Status unknown.

Timeline

1 November 2020

Primary endpoint
15 November 2023

15 November 2023

Quick facts

Lead sponsor	Sheba Medical Center
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 November 2020
Primary completion	15 November 2023
Estimated completion	15 November 2023

Drugs / interventions tested

Romosozumab (romosozumab) — full drug profile →
Zoledronic Acid (ZOLEDRONIC ACID) — full drug profile →

Conditions studied

Osteoporosis Fracture — all drugs for Osteoporosis Fracture →
Spinal Cord Injuries — all drugs for Spinal Cord Injuries →

Sponsor

Sheba Medical Center

Who can join

Adults 20 to 70, female only, with Osteoporosis Fracture or Spinal Cord Injuries. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Osteoporosis Treatment with Anti-Sclerostin Antibodies-Mechanisms of Action and Clinical Application.
Rauner M, Rauner M, Taipaleenmäki H, Tsourdi E, et al · · 2021 · cited 46× · PMID 33669283 · DOI 10.3390/jcm10040787
Preventing OsteoPorosis in Spinal Cord Injury (POPSCI) Study-Early Zoledronic Acid Infusion in Patients with Acute Spinal Cord Injury.
Kumar S, Doyle J, Wood C, Heriseanu R, et al · · 2024 · PMID 39320468 · DOI 10.1007/s00223-024-01292-3

Verify or expand the search:

Other trials of Romosozumab

Trials testing the same drug.

NCT07283887 — Romosozumab and Denosumab, Alone or Combined, in Postmenopausal Osteoporosis · Phase 4 · recruiting
NCT07384104 — Compare the Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of SAL023 and Italy-Manufactured Evenity in He · Phase 1 · enrolling by invitation
NCT06558188 — Combined Anabolic Therapy · Phase 4 · recruiting
NCT05972551 — Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Oste · Phase 3 · recruiting
NCT06079476 — A Study of Romosozumab (EVENITY®) in Postmenopausal Women in India With Osteoporosis at a High Risk of Fracture. · Phase 4 · completed

Other recruiting trials for Osteoporosis Fracture

Currently open trials in the same condition.

NCT06551155 — Peripheral Mononuclear Cells to Screen, Monitor and Stratify the Population at Risk of Osteoporosis and Fractures · recruiting
NCT06525688 — New Biomarkers and Therapeutic Targets in Osteoporosis Via Omics Technologies · recruiting
NCT06379243 — Development and Validation of a Postoperative Re-fracture Risk Model for Osteoporotic Spinal Fractures · NA · recruiting
NCT05058976 — Romosozumab Use to Build Skeletal Integrity · Phase 4 · active not recruiting

Other Sheba Medical Center trials

Trials by the same sponsor.

NCT07401524 — Carbetocin Uterotonic Treatment in Twin Pregnancies for Prevention of Postpartum Hemorrhage · Phase 4 · not yet recruiting
NCT07523373 — Facial Nerve Monitoring During Parotid and Facial Surgery Using a Non-Invasive Patch · NA · not yet recruiting
NCT07509229 — 9-cis Beta-Carotene-Rich Extract of Dunaliella Alga in Retinitis Pigmentosa Patients · Phase 1, PHASE2 · not yet recruiting
NCT07405723 — Arm Position and Blood Pressure Measurement Accuracy During Pregnancy · NA · recruiting
NCT07474987 — Portable VR-based Chromatic Pupilloperimeter for Diagnosis and Monitoring of Traumatic Brain Injury · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04597931 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sheba Medical Center
Last refreshed: 22 October 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04597931.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing