Denosumab vs Zoledronic Acid and Osteoporotic Compression Fracture

NCT05106517 | Unknown Phase 2 DMC

• 1 other identifier: ShenzhenPH spine wang04
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Denosumab vs Zoledronate

Outcome Measures

Primary Outcomes (12)

• 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 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

• Serum total calcium

  Serum total calcium 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

  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

• 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 Outcomes (3)

• The Roland-Morris Disability Questionnaire

  up to 12 month

• QUALEFFO-31

  up to 12 month

• EuroQol-5D (EQ-5D)

  up to 12 month

Study Arms (2)

denosumab

EXPERIMENTAL

Denosumab 60mg/6 months subcutaneously + placebo intravenous

Drug: Denosumab

zoledronic acid

EXPERIMENTAL

intravenous zoledronic acid and placebo /6 months subcutaneously

Drug: Zoledronic acid

Interventions

Denosumab DRUG

Denosumab 60mg/6 months subcutaneously + placebo iv

Also known as: Denosumab 6 month/subcutaneous

denosumab

Zoledronic acid DRUG

Iv zoledronic acid and placebo /6 months subcutaneously

Also known as: Zoledronic acid intravenous once a year

zoledronic acid

Eligibility Criteria

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

You may qualify if:

• 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

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 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

Sponsors & Collaborators

• Shenzhen People's Hospital: lead

Study Sites (1)

ShenzhenPH

Shenzhen, Guangdong, 518000, China

RECRUITING

MeSH Terms

Interventions

Denosumab; Injections, Subcutaneous; Zoledronic Acid

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Hongyu Wang, Doctor

CONTACT

18241651300; wanghongyu790039663@126.com

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: October 9, 2021
• First Posted: November 3, 2021
• Study Start: September 8, 2021
• Primary Completion: March 5, 2023
• Study Completion: March 11, 2023
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)