Recombinant Human Bone Morphogenetic Protein-2(rhBMP-2) in Patients With Osteoporosis After Lumbar Fusion

NCT05911477 | Unknown DMC

• 1 other identifier: 20222249-1
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

Brief Summary

rhBMP-2 has been used to promote spinal fusion. Despite potential risk of complications, satisfied results could be obtained with low dose of rhBMP-2. Effect of early bone formation has been validated using rat ovariectomy osteoporosis model. However, whether it functioned in patients with osteoporosis remained unknown. In this study, the investigators intend to investigate whether rhBMP-2 promotes early bone formation in patients with osteoporosis after transforaminal lumbar interbody fusion (TLIF).

Conditions

Osteoporosis; Spinal Fusion

Keywords

rhBMP-2, lumbar fusion, fusion rate, osteoporosis

Outcome Measures

Primary Outcomes (2)

• Fusion rate at 6 months

  1. \<5°of angular motion, ≤3 mm of translation from lumbar spine dynamic radiographs 2. Bridging bone connecting the adjacent vertebral bodies either through the implants or around the implants, and an absence of radiolucent lines around \>50% of either implant from computed tomography (CT) scans of lumbar

  6 months follow-up

• Fusion rate at 3 months

  \<5°of angular motion, ≤3 mm of translation from lumbar spine dynamic radiographs of radiolucent lines around \>50% of either implant

  3 months follow-up

Secondary Outcomes (5)

• Visual Analog Score for low back pain (VAS-B)

  pre- and post-operative immediately, 3- and 6- months follow-up

• Visual Analog Score for leg pain (VAS-L)

  pre- and post-operative immediately, 3- and 6- months follow-up

• Oswestry disability index (ODI)

  pre-operatively, 3- and 6-months follow-up

• 36-Item Short Form Survey (SF-36)

  pre-operatively, 3- and 6-months follow-up

• Incidence of complications

  post-operative immediately, 3- and 6- months follow-up

Study Arms (2)

rhBMP-2 group

EXPERIMENTAL

Drug: RhBMP-2

No rhBMP-2 group

NO INTERVENTION

Interventions

RhBMP-2 DRUG

1mg RhBMP-2 for one fusion-level

rhBMP-2 group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients diagnosed with degenerative lumbar diseases.
• patients underwent one-level TLIF
• osteoporosis (DXA T≤-2.5)
• complete preoperative and follow-up data (imaging and health-related quality of life)

You may not qualify if:

• history of previous spinal surgery
• inflammatory and neoplastic diseases

Sponsors & Collaborators

• Xijing Hospital: lead

MeSH Terms

Conditions

Osteoporosis

Interventions

Bone Morphogenetic Protein 2

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Bone Morphogenetic Proteins; TGF-beta Superfamily Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 22, 2023
• Study Start: July 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: one year after the study is finished.
• Access Criteria: Through emails after Obtaining written permission from the investigator