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Denosumab vs Zoledronate After Vertebroplasty

Primary Purpose

Denosumab Allergy, Zoledronic Acid Allergy

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Denosumab Injection
Zoledronate
Sponsored by
Shenzhen People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Denosumab Allergy

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Active Comparator

Arm Label

Denosumab

zoledronate

Arm Description

1 ml (60 mg) of denosumab (Prolia; Amgen, Inc) subcutaneous injection plus intravenous placebo every 6 months

Intravenous zoledronic acid 5 mg plus subcutaneous placebo every 12 months.

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, 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
October 25, 2022
Last Updated
January 15, 2023
Sponsor
Shenzhen People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05598606
Brief Title
Denosumab vs Zoledronate After Vertebroplasty
Official Title
Denosumab vs Zoledronate in Patients With Osteoporotic Vertebral Compression Fracture After Percutaneous Vertebroplasty: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 12, 2021 (Actual)
Primary Completion Date
January 10, 2023 (Actual)
Study Completion Date
January 14, 2023 (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
Osteoporotic vertebral compression fracture (OVCF) patients had a proportion of secondary fractures after percutaneous vertebroplasty (PVP). Denosumab and zoledronate acid is both effective to prevent bone loss for OVCF postmenopausal women. However, trial evidence comparing effect of denosumab vs zoledronate after PVP was unknown. The study aims to assess the efficiency of denosumab vs zoledronate for OVCF patients bone mineral density (BMD), bone turnover markers (BTMs), secondary fracture and adverse events after PVP.
Detailed Description
Whether denosumab was non-inferior than zoledronate in improving bone mineral density (BMD), bone turnover markers (BTMs), functional status questionnaires, and secondary fracture in elderly patients with OVCF after PVP remains unknown. A prospective, randomized, placebo-controlled clinical trial in OVCF patients with PVP was performed. This study aimed to investigate the efficiency of denosumab vs zoledronate on BMD, BTMs, functional status, secondary fracture rate, and adverse events in OVCF patients after PVP 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
Denosumab Allergy, Zoledronic Acid Allergy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Participants were randomized using a block randomization model (block size 5). Computer-generated, random-number sequences were prepared by an experienced statistician. Consecutive treatment allocations were stored in sealed opaque envelopes and assigned to doctors. Patients and doctors were blinded to the assignments; all researchers and data analysts were blinded as to the allocation during the 12-month follow-up period.
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Denosumab
Arm Type
Experimental
Arm Description
1 ml (60 mg) of denosumab (Prolia; Amgen, Inc) subcutaneous injection plus intravenous placebo every 6 months
Arm Title
zoledronate
Arm Type
Active Comparator
Arm Description
Intravenous zoledronic acid 5 mg plus subcutaneous placebo every 12 months.
Intervention Type
Drug
Intervention Name(s)
Denosumab Injection
Other Intervention Name(s)
Denosumab 6 month/subcutaneous
Intervention Description
1 ml (60 mg) of denosumab (Prolia; Amgen, Inc) subcutaneous injection plus intravenous placebo every 6 months (Q6M)
Intervention Type
Drug
Intervention Name(s)
Zoledronate
Other Intervention Name(s)
Zoledronic acid intravenous once a year
Intervention Description
Intravenous zoledronic acid 5 mg plus subcutaneous placebo every 12 months
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, 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
No
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

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Denosumab vs Zoledronate After Vertebroplasty

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