Denosumab vs Zoledronic Acid and Osteoporotic Compression Fracture

Study Overview
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Brief Summary
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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

Detailed Description
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Conduct a single-center, double-blind, randomized controlled clinical trial according to clinical Trial Reporting Standards (CONSORT). Bone mineral density and function of osteoporotic vertebral compression fracture (OVCF) were compared 1 year after screw internal fixation with denosumab vs zoledronic acid in Shenzhen People's Hospital from September, 2021 to November, 2022. The study was approved by Shenzhen People's Hospital and informed consent was signed.

Official Title
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Attending Physician of Shenzhen People's Hospital

Conditions
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Denosumab vs Zoledronate

Intervention / Treatment
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* Drug: Denosumab
* Drug: Zoledronic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: denosumab<br>Denosumab 60mg/6 months subcutaneously + placebo intravenous | Drug: Denosumab<br>* Denosumab 60mg/6 months subcutaneously + placebo iv<br>* Other names: Denosumab 6 month/subcutaneous;|
| Experimental: zoledronic acid<br>intravenous zoledronic acid and placebo /6 months subcutaneously | Drug: Zoledronic acid<br>* Iv zoledronic acid and placebo /6 months subcutaneously<br>* Other names: Zoledronic acid intravenous once a year;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Roland-Morris Disability Questionnaire | The Roland-Morris Disability Questionnaire is a health status measure designed to be completed by patients to assess physical disability due to low back pain. | up to 12 month | 
| QUALEFFO-31 | Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) was developed in 1997 to evaluate quality of life for patients with osteoporosis. The questionnaire assesses quality of life in the aspect of pain, physical function, social function, general health, and mental health | up to 12 month | 
| EuroQol-5D (EQ-5D) | EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. | up to 12 month |