NCT05638399

Brief Summary

The aim of the study was to compare denosumab and zoledronate efficacy in bone mass, bone turnover markers (BTMs), Visual Analogue Scale (VAS) for leg and back, EuroQol Five-Dimension (EQ-5D) scores, Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 (QUALEFFO-31) scores, and Roland-Morris Disability Functioning Questionnaire (RMDQ) scores, secondary fracture, complications and adverse events after lumbar fusion.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2020

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2020

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 6, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

3.1 years

First QC Date

November 25, 2022

Last Update Submit

February 18, 2023

Conditions

OsteopeniaLumbar Spondylolisthesis

Outcome Measures

Primary Outcomes (6)

  • Lumbar bone mineral density(BMD)

    Lumbar vertebral (L1 to L4, except the surgery segment) BMD were determined at baseline, 6 and 12 months via dual energy X-ray

    up to 12 months

  • Total hip BMD

    Total hip BMD were determined at baseline, 6 and 12 months via dual-energy X-ray

    up to 12 months

  • Femoral neck BMD

    Femoral neck BMD were determined at baseline, 6 and 12 month via dual-energy X-ray

    up to 12 months

  • Procollagen type 1 n-terminal propeptide (P1NP)

    Bone formation marker, P1NP were determined at baseline, 6 and 12 months after surgery

    up to 12 months

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

    Bone resorption marker, CTX were determined at baseline, 6 and 12 months after surgery

    up to 12 months

  • Visual analog scale (VAS) back

    The VAS score for back pain were determined at baseline, 6 and 12 month. Use a ruler about 10cm long, one side is marked with "0" and the other "10" respectively. A score of 0 indicates no pain, 10 indicates the most unbearable pain.

    up to 12 months

Secondary Outcomes (6)

  • The Roland-Morris Disability Questionnaire

    up to 12 month

  • The QUALEFFO-31 Questionnaire

    up to 12 month

  • The EQ-5D Questionnaire

    up to 12 month

  • New fracture rate

    up to 12 month

  • Complications

    up to 12 month

  • +1 more secondary outcomes

Study Arms (2)

Denosumab

EXPERIMENTAL

denosumab (60 mg subcutaneously, per 6 month)

Drug: Denosumab 60 mg/ml [Prolia]

zoledronate

ACTIVE COMPARATOR

zoledronate (5mg, intravenous infusion once a year)

Drug: Zoledronate

Interventions

Denosumab 60 mg/ml [Prolia]DRUG

60 mg subcutaneously per 6 month

Also known as: Denosumab 6 month/subcutaneous
Denosumab
ZoledronateDRUG

5mg, intravenous infusion once a year

Also known as: Zoledronic acid
zoledronate

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants aged 40 to 85 years
  • who diagnosed with lumbar spinal stenosis or lumbar spondylolisthesis
  • osteopenia with BMD T score between -1 and -2.5 via dual energy X-ray
  • low back pain or leg numbness or weakness
  • MRI demonstrated signs of nerve compression
  • patients with one or two level symptoms.

You may not qualify if:

  • cauda equina syndrome
  • progressive neurologic deficit
  • history of cancer
  • scoliosis greater than 15°
  • back open surgery history
  • have contraindications for surgery
  • who had anti-osteoporosis medication within 6 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ShenzhenPH

Shenzhen, Guangdong, 518000, China

RECRUITING

MeSH Terms

Conditions

Bone Diseases, MetabolicSpondylolisthesis

Interventions

DenosumabInjections, SubcutaneousZoledronic Acid

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesSpondylolysisSpondylosisSpinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsInjectionsDrug Administration RoutesDrug TherapyTherapeuticsDiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Songlin Peng, Doctor

    Shenzhen People's Hospital

    STUDY CHAIR

Central Study Contacts

Hongyu Wang, Doctor

CONTACT

18241651300wanghongyu790039663@126.com

Song Wang, Master

CONTACT

18085243269835990429@qq.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2022

First Posted

December 6, 2022

Study Start

January 15, 2020

Primary Completion

February 26, 2023

Study Completion

February 28, 2023

Last Updated

February 21, 2023

Record last verified: 2023-02

Locations

CN(1)