Denosumab and Screw Fixation for Osteoporotic Compression Fracture

NCT05065164 | Withdrawn Phase 2 DMC

• 1 other identifier: ShenzhenPH spine wang02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of bone mineral density and function at 1 year after screw internal fixation of osteoporotic vertebral compression fractures with desuzumab: a parallel double-blind randomized controlled clinical trial

Conditions

Denosumab Allergy

Outcome Measures

Primary Outcomes (15)

• age

  participants age (year)

  up to 12 months

• sex

  participants sex

  up to 12 months

• height

  participants height cm

  up to 12 months

• weight

  participants weight kg

  up to 12 months

• BMI

  participants body mass index

  up to 12 months

• osteocalcin

  osteocalcin in the N terminal molecular fragment

  up to 12 months

• Procollagen type 1 n-terminal propeptide P1NP

  Procollagen type 1 n-terminal propeptide

  up to 12 months

• C-terminal cross-linked type 1 collagen terminal peptide CTX

  C-terminal cross-linked type 1 collagen terminal peptide

  up to 12 months

• Serum total calcium

  Serum total calcium level

  up to 12 months

• parathyroid hormone

  serum parathyroid hormone level

  up to 12 months

• albumin

  serum albumin level

  up to 12 months

• lumber spine bone mineral density

  Dual energy X-ray for lumber spine bone mineral density

  up to 12 months

• Hip bone mineral density

  Dual energy X-ray for hip bone mineral density

  up to 12 months

• MRI of lumber

  Bone marrow edema and adjacent intervertebral disc were detected by MRI

  up to 12 months

• pain visual analogue scores (VAS)

  pain visual analogue scores (VAS) use categories to differentiate pain intensity, with 0 being "painless" and 100 being "the worst pain imaginable".

  up to 12 months

Secondary Outcomes (3)

• The Roland-Morris Disability Questionnaire

  up to 12 month

• QUALEFFO 31

  up to 12 month

• EuroQol-5D (EQ-5D): an instrument for measuring quality of life

  up to 12 month

Study Arms (2)

dnosumab

EXPERIMENTAL

Desuzumab 60 mg subcutaneously /6 months, twice a year

Drug: Denosumab Only Product

placebo control

PLACEBO COMPARATOR

Placebo subcutaneous injection /6 months, twice a year

Drug: Denosumab Only Product

Interventions

Denosumab Only Product DRUG

denosumab subcutaneous injection /6 months, twice a year

Also known as: Denosumab

dnosumab; placebo control

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• X-ray diagnosis of 1-2 vertebral compression fractures
• Dual energy X ray test bone mineral density T value less than -1
• fracture history lasted within 6 weeks
• MRI showed bone marrow edema of injured segment
• lower back pain, local spines tenderness

You may not qualify if:

• Must be able to have no posterior vertebral wall fracture
• Must be able to have no patients with intervertebral fissure
• Must be able to have no infection
• Must be able to have no malignancy
• Must be able to have no neurological dysfunction
• Must be able to have no previous use of anti-osteoporosis drugs within 6 weeks
• Must be able to have no inability to perform magnetic resonance imaging
• Must be able to have no prior back surgery
• Must be able to have no other established contraindications for elective surgery

Sponsors & Collaborators

• Shenzhen People's Hospital: lead

Study Sites (1)

ShenzhenPH

Shenzhen, Guangdong, 518000, China

Location

MeSH Terms

Interventions

Denosumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Hongyu Wang, Doctor

  Shenzhen People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 1, 2021
• Study Start: September 14, 2021
• Primary Completion: March 20, 2023
• Study Completion: September 25, 2023
• Last Updated: March 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)