Denosumab and Screw Fixation for Osteoporotic Compression Fracture

Attending Doctor of Shenzhen People's Hospital

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

Study Overview

• Status: Withdrawn
• Conditions: Denosumab Allergy
• Intervention / Treatment: Drug: Denosumab Only Product

Detailed Description

Conduct a single-center, double-blind, randomized controlled clinical trial according to clinical Trial Reporting Standards (CONSORT). Bone mineral density and function were compared 1 year after screw internal fixation of osteoporotic vertebral compression fracture (OVCF) with desomumab versus placebo in Shenzhen People's Hospital from September, 2021 to September, 2022. The study was approved by Shenzhen People's Hospital and informed consent was signed

• Study Type: Interventional
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Hongyu Wang, Doctor; Phone Number: 18241651300; Email: wanghongyu790039663@126.com
• Study Contact Backup: Name: Song Wang, Master; Phone Number: 18841609587; Email: 2362380008@qq.com

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518000
      • ShenzhenPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:• Must be age between 40 and 90 years old

• 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

Exclusion Criteria:

• • 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dnosumab; Desuzumab 60 mg subcutaneously /6 months, twice a year	Drug: Denosumab Only Product; denosumab subcutaneous injection /6 months, twice a year; Other Names: Denosumab
Placebo Comparator: placebo control; Placebo subcutaneous injection /6 months, twice a year	Drug: Denosumab Only Product; denosumab subcutaneous injection /6 months, twice a year; Other Names: Denosumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sex	participants sex	up to 12 months
height	participants height cm	up to 12 months
BMI	participants body mass index	up to 12 months
Serum total calcium	Serum total calcium level	up to 12 months
age	participants age (year)	up to 12 months
weight	participants weight kg	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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Roland-Morris Disability Questionnaire	The Roland-Morris Disability Questionnaire is a health status measure designed to be completed by patients to assess physical disability due to low back pain.	up to 12 month
QUALEFFO 31	Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) was developed in 1997 to evaluate quality of life for patients with osteoporosis	up to 12 month
EuroQol-5D (EQ-5D): an instrument for measuring quality of life	EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.	up to 12 month

Collaborators and Investigators

• Sponsor: Shenzhen People's Hospital
• Investigators: Principal Investigator: Hongyu Wang, Doctor, ShenZhen People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2021
• Primary Completion (Anticipated): March 20, 2023
• Study Completion (Anticipated): September 25, 2023

Study Registration Dates

• First Submitted: September 22, 2021
• First Submitted That Met QC Criteria: September 22, 2021
• First Posted (Actual): October 1, 2021

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 11, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Bone Density Conservation Agents; Denosumab
• Other Study ID Numbers: ShenzhenPH spine wang02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No