Denosumab vs Zoledronic Acid and Osteoporotic Compression Fracture

Attending Physician of Shenzhen People's Hospital

Bone mineral density and function at 1 year after screw fixation with denosumab vs zoledronic acid for osteoporotic vertebral compression fractures: a parallel double-blind randomized controlled clinical trial

Study Overview

• Status: Recruiting
• Conditions: Denosumab vs Zoledronate
• Intervention / Treatment: Drug: Zoledronic acid; Drug: Denosumab

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 122
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Hongyu Wang, Doctor; Phone Number: 18241651300; Email: wanghongyu790039663@126.com

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518000
      • Recruiting
      • ShenzhenPH
      • Contact: Hongyu Wang, Doctor; Phone Number: 18241651300; Email: wanghongyu790039663@126.com

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 eneragy X ray test for bone mineral density T value less than -1
• fracture history lasted within 6 weeks
• Must be MRI showed bone marrow edema of injured segment
• Must be 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 calcium level ≤2.13 mmol/L
• Must be able to have no previous use of anti-osteoporosis drugs
• 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: zoledronic acid; intravenous zoledronic acid and placebo /6 months subcutaneously	Drug: Zoledronic acid; Iv zoledronic acid and placebo /6 months subcutaneously; Other Names: Zoledronic acid intravenous once a year
Experimental: denosumab; Denosumab 60mg/6 months subcutaneously + placebo intravenous	Drug: Denosumab; Denosumab 60mg/6 months subcutaneously + placebo iv; Other Names: Denosumab 6 month/subcutaneous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
age	participants age	up to 12 months
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
hip bone mineral density	DEXA for hip bone mineral density	up to 12 months
MRI for lumber	Bone marrow edema and adjacent intervertebral disc were detected by MRI	up to 12 months
serum osteocalcin	osteocalcin in the N terminal molecular fragment	up to 12 months
serum Procollagen type 1 n-terminal propeptide P1NP	Procollagen type 1 n-terminal propeptide	up to 12 months
serum C-terminal cross-linked type 1 collagen terminal peptide CTX	C-terminal cross-linked type 1 collagen terminal peptide	up to 12 months
lumber spine bone mineral density	Dual energy X ray for lumber spine bone mineral density	up to 12 months
pain visual analogue scores (VAS)	pain visual analogue scores (VAS) use categories to differentiate pain intensity. There is a wide variability of terms used to describe each category and the rating may be divided into four (0 -3) or six (0 -5) categories. Patients score their pain intensity from absent (0) to severe (3) or from none (0) to very severe (5)	up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EuroQol-5D (EQ-5D)	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
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. The questionnaire assesses quality of life in the aspect of pain, physical function, social function, general health, and mental health	up to 12 month

Collaborators and Investigators

• Sponsor: Shenzhen People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2021
• Primary Completion (Anticipated): March 5, 2023
• Study Completion (Anticipated): March 11, 2023

Study Registration Dates

• First Submitted: October 9, 2021
• First Submitted That Met QC Criteria: October 22, 2021
• First Posted (Actual): November 3, 2021

Study Record Updates

• Last Update Posted (Estimate): February 21, 2023
• Last Update Submitted That Met QC Criteria: February 18, 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; Zoledronic Acid; Denosumab
• Other Study ID Numbers: ShenzhenPH spine wang04

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