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Denosumab and Osteoporotic Vertebral Compression Fracture

Primary Purpose

Osteoporotic Vertebral Compression Fracture

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Denosumab 60 mg/ml [Prolia]
Placebo
Sponsored by
Shenzhen People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporotic Vertebral Compression Fracture focused on measuring denosumab, vertebroplasty

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Must be age between 50 and 90 years old
  • X-ray diagnosis of 1 or 2 segment vertebral compression fractures from T4 to L5
  • Bone mineral density T value less than -1 via dual-energy X-ray
  • A recent fracture history less than 6 weeks
  • MRI show bone marrow edema of fractured vertebrae
  • low back pain, local paravertebral tenderness

Exclusion Criteria:

  • Must be able to have no 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
  • Must be able to have no inability to perform magnetic resonance imaging
  • Must be able to have no prior back open surgery
  • Must be able to have no other established contraindications for elective surgery

Sites / Locations

  • ShenzhenPH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Denosumab

Placebo

Arm Description

Denosumab 60 mg were injected subcutaneously every 6 months (Q6M)

Equal volume of saline (0.9%) as placebo were injected subcutaneously every 6 months (Q6M)

Outcomes

Primary Outcome Measures

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
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
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 EQ-5D questionnaire evaluates health status consisting five dimensions: mobility, self-care, 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).
Secondary fracture rate
Secondary 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.
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

First Posted
September 16, 2021
Last Updated
February 18, 2023
Sponsor
Shenzhen People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05058443
Brief Title
Denosumab and Osteoporotic Vertebral Compression Fracture
Official Title
Denosumab Protects Bone Loss and Function in Patients With Osteoporotic Vertebral Compression Fracture After Percutaneous Vertebroplasty: a Randomized Placebo-controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 6, 2020 (Actual)
Primary Completion Date
August 5, 2022 (Actual)
Study Completion Date
August 10, 2022 (Actual)

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
This study aimed to investigate the effect of denosumab on bone mineral density(BMD), bone turnover markers(BTMs), functional status, secondary fracture rate, and adverse effects in osteoporotic vertebral compression fracture (OVCF) patients after vertebroplasty during a 12-month follow-up period.
Detailed Description
We performed a single-center, placebo-controlled, randomized clinical trial in the Department of Spinal Surgery located at the First Affiliated Hospital of Southern University of Science and Technology (Shenzhen People's Hospital). All patients underwent vertebroplasty and randomly received denosumab treatment or placebo control after surgery. The BMDs (lumbar, total hip, and femoral neck) and BTMs were assessed at baseline, 6, and 12 months post-operation. The visual analog scale (VAS) score for back pain, and function status questionnaires, including EuroQol five-dimension (EQ-5D), the Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 (QUALEFFO-31), and the Roland-Morris Disability Functioning Questionnaire (RMDQ),secondary fracture rate, and adverse effects in OVCF patients after vertebroplasty during a 12-month follow-up period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporotic Vertebral Compression Fracture
Keywords
denosumab, vertebroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Denosumab
Arm Type
Experimental
Arm Description
Denosumab 60 mg were injected subcutaneously every 6 months (Q6M)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Equal volume of saline (0.9%) as placebo were injected subcutaneously every 6 months (Q6M)
Intervention Type
Drug
Intervention Name(s)
Denosumab 60 mg/ml [Prolia]
Other Intervention Name(s)
Denosumab
Intervention Description
denosumab subcutaneously every 6 months (Q6M)
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
equal volume of saline (0.9%)
Intervention Description
placebo subcutaneously every 6 months (Q6M)
Primary Outcome Measure Information:
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
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
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 EQ-5D questionnaire evaluates health status consisting five dimensions: mobility, self-care, 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
Secondary fracture rate
Description
Secondary 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
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
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Must be age between 50 and 90 years old X-ray diagnosis of 1 or 2 segment vertebral compression fractures from T4 to L5 Bone mineral density T value less than -1 via dual-energy X-ray A recent fracture history less than 6 weeks MRI show bone marrow edema of fractured vertebrae low back pain, local paravertebral tenderness Exclusion Criteria: Must be able to have no 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 Must be able to have no inability to perform magnetic resonance imaging Must be able to have no prior back open surgery Must be able to have no other established contraindications for elective surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiao Xiao, Doctor
Organizational Affiliation
Shenzhen People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
ShenzhenPH
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33305593
Citation
Chang R, Qian X, Xuan Z, Xu Y, Chen Y, Gu H, Fu C. Health related quality of life and its impacts by chronic diseases in urban community population, Shanghai, China in 2015. Psychol Health Med. 2021 Sep;26(8):931-939. doi: 10.1080/13548506.2020.1856896. Epub 2020 Dec 11.
Results Reference
result
PubMed Identifier
26070551
Citation
Zhou C, Li Q, Huang S, Fan L, Wang B, Dai J, Tang X. Validation of the simplified Chinese version of the quality of life questionnaire of the European foundation for osteoporosis (QUALEFFO-31). Eur Spine J. 2016 Jan;25(1):318-324. doi: 10.1007/s00586-015-4066-z. Epub 2015 Jun 14.
Results Reference
result
PubMed Identifier
26687949
Citation
Stevens ML, Lin CC, Maher CG. The Roland Morris Disability Questionnaire. J Physiother. 2016 Apr;62(2):116. doi: 10.1016/j.jphys.2015.10.003. Epub 2015 Dec 11. No abstract available.
Results Reference
result

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Denosumab and Osteoporotic Vertebral Compression Fracture

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