Back to resultsDenosumab vs Zoledronate After Lumbar Fusion
Primary Purpose
Osteopenia, Lumbar Spondylolisthesis
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Denosumab 60 mg/ml [Prolia]
Zoledronate
Sponsored by
About this trial
This is an interventional treatment trial for Osteopenia
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Sites / Locations
- ShenzhenPHRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Denosumab
zoledronate
Arm Description
denosumab (60 mg subcutaneously, per 6 month)
zoledronate (5mg, intravenous infusion once a year)
Outcomes
Primary Outcome Measures
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
Total hip BMD
Total hip BMD were determined at baseline, 6 and 12 months via dual-energy X-ray
Femoral neck BMD
Femoral neck BMD were determined at baseline, 6 and 12 month via dual-energy X-ray
Procollagen type 1 n-terminal propeptide (P1NP)
Bone formation marker, P1NP were determined at baseline, 6 and 12 months after surgery
C-terminal cross-linked type 1 collagen terminal peptide (CTX)
Bone resorption marker, CTX were determined at baseline, 6 and 12 months after surgery
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.
Secondary Outcome Measures
The Roland-Morris Disability Questionnaire
The Roland-Morris Disability Questionnaire is scored by 24 adding up the number of items checked "yes" on different low back pain-related daily activity disabilities. Total scores range from 0 to 24, with higher scores 24 indicating a higher level of disability related to low back pain and lowest 0 represents no back pain.
The QUALEFFO-31 Questionnaire
The Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 (QUALEFFO-31), which contains three domains including pain, physical function, and mental function. This scale is assessed on a scale of 0 to 100, with 0 indicating the highest QoL and 100 the lowest.
The EQ-5D Questionnaire
The EuroQol five-dimension (EQ-5D) questionnaire evaluates health status consisting five dimensions: mobility, selfcare, performance of usual activities, pain or discomfort, and anxiety or depression. After conversion, the index was between 0 and 1.0 (minimum score: 0, indicating worst health state; full score:1.0, indicating full health).
New fracture rate
New fracture rate containing vertebral fracture and non-vertebral fracture was assessed at 12 month after surgery. The lowest score was 0, the highest score was 100%. The lower score 0 represents no secondary fracture.
Complications
Complications including cage subsidence, pedicle screw loosening, infection, peripheral nerve injury, and recurrent symptoms were assessed.
Adverse events
The main adverse events including deep venous thrombosis, pneumonia, acute renal failure, pulmonary embolism, myocardial infarction, influenza, transfer to intensive care unit, joint pain, headache, nausea, osteonecrosis of the jaw, atypical femoral fracture and rash.
Full Information
NCT ID
NCT05638399
First Posted
November 25, 2022
Last Updated
February 18, 2023
Sponsor
Shenzhen People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05638399
Brief Title
Denosumab vs Zoledronate After Lumbar Fusion
Official Title
Denosumab vs Zoledronate Efficacy in Osteopenic Patients With Lumbar Degenerative Disease After Lumbar Fusion Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2020 (Actual)
Primary Completion Date
February 26, 2023 (Anticipated)
Study Completion Date
February 28, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Lumbar degenerative disease including spinal stenosis and lumbar spondylolisthesis were the most common reason lead to older patients disability, which was the main indication for older patients to perform lumbar fusion surgery. For patients with lumbar degenerative disease older than 50 years old, a proportion of patients had osteoporosis. The trial aims to investigate whether denosumab versus zoledronate acid in osteopenic patients with lumbar fusion surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteopenia, Lumbar Spondylolisthesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Denosumab
Arm Type
Experimental
Arm Description
denosumab (60 mg subcutaneously, per 6 month)
Arm Title
zoledronate
Arm Type
Active Comparator
Arm Description
zoledronate (5mg, intravenous infusion once a year)
Intervention Type
Drug
Intervention Name(s)
Denosumab 60 mg/ml [Prolia]
Other Intervention Name(s)
Denosumab 6 month/subcutaneous
Intervention Description
60 mg subcutaneously per 6 month
Intervention Type
Drug
Intervention Name(s)
Zoledronate
Other Intervention Name(s)
Zoledronic acid
Intervention Description
5mg, intravenous infusion once a year
Primary Outcome Measure Information:
Title
Lumbar bone mineral density(BMD)
Description
Lumbar vertebral (L1 to L4, except the surgery segment) BMD were determined at baseline, 6 and 12 months via dual energy X-ray
Time Frame
up to 12 months
Title
Total hip BMD
Description
Total hip BMD were determined at baseline, 6 and 12 months via dual-energy X-ray
Time Frame
up to 12 months
Title
Femoral neck BMD
Description
Femoral neck BMD were determined at baseline, 6 and 12 month via dual-energy X-ray
Time Frame
up to 12 months
Title
Procollagen type 1 n-terminal propeptide (P1NP)
Description
Bone formation marker, P1NP were determined at baseline, 6 and 12 months after surgery
Time Frame
up to 12 months
Title
C-terminal cross-linked type 1 collagen terminal peptide (CTX)
Description
Bone resorption marker, CTX were determined at baseline, 6 and 12 months after surgery
Time Frame
up to 12 months
Title
Visual analog scale (VAS) back
Description
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.
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
The Roland-Morris Disability Questionnaire
Description
The Roland-Morris Disability Questionnaire is scored by 24 adding up the number of items checked "yes" on different low back pain-related daily activity disabilities. Total scores range from 0 to 24, with higher scores 24 indicating a higher level of disability related to low back pain and lowest 0 represents no back pain.
Time Frame
up to 12 month
Title
The QUALEFFO-31 Questionnaire
Description
The Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 (QUALEFFO-31), which contains three domains including pain, physical function, and mental function. This scale is assessed on a scale of 0 to 100, with 0 indicating the highest QoL and 100 the lowest.
Time Frame
up to 12 month
Title
The EQ-5D Questionnaire
Description
The EuroQol five-dimension (EQ-5D) questionnaire evaluates health status consisting five dimensions: mobility, selfcare, performance of usual activities, pain or discomfort, and anxiety or depression. After conversion, the index was between 0 and 1.0 (minimum score: 0, indicating worst health state; full score:1.0, indicating full health).
Time Frame
up to 12 month
Title
New fracture rate
Description
New fracture rate containing vertebral fracture and non-vertebral fracture was assessed at 12 month after surgery. The lowest score was 0, the highest score was 100%. The lower score 0 represents no secondary fracture.
Time Frame
up to 12 month
Title
Complications
Description
Complications including cage subsidence, pedicle screw loosening, infection, peripheral nerve injury, and recurrent symptoms were assessed.
Time Frame
up to 12 month
Title
Adverse events
Description
The main adverse events including deep venous thrombosis, pneumonia, acute renal failure, pulmonary embolism, myocardial infarction, influenza, transfer to intensive care unit, joint pain, headache, nausea, osteonecrosis of the jaw, atypical femoral fracture and rash.
Time Frame
up to 12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongyu Wang, Doctor
Phone
18241651300
Email
wanghongyu790039663@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Song Wang, Master
Phone
18085243269
Email
835990429@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Songlin Peng, Doctor
Organizational Affiliation
Shenzhen People's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
ShenzhenPH
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongyu Wang, Doctor
Phone
18241651300
Email
wanghongyu790039663@126.com
First Name & Middle Initial & Last Name & Degree
Song Wang, Master
Phone
18085243269
Email
2362380008@qq.com
12. IPD Sharing Statement
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Denosumab vs Zoledronate After Lumbar Fusion
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