Denosumab and Screw Fixation for Osteoporotic Compression Fracture

Study Overview
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Brief Summary
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Evaluation of bone mineral density and function at 1 year after screw internal fixation of osteoporotic vertebral compression fractures with desuzumab: 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 were compared 1 year after screw internal fixation of osteoporotic vertebral compression fracture (OVCF) with desomumab versus placebo in Shenzhen People's Hospital from September, 2021 to September, 2022. The study was approved by Shenzhen People's Hospital and informed consent was signed

Official Title
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Attending Doctor of Shenzhen People's Hospital

Conditions
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Denosumab Allergy

Intervention / Treatment
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* Drug: Denosumab Only Product


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 energy X ray test bone mineral density T value less than -1 fracture history lasted within 6 weeks MRI showed bone marrow edema of injured segment 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 previous use of anti-osteoporosis drugs within 6 weeks 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: dnosumab<br>Desuzumab 60 mg subcutaneously /6 months, twice a year | Drug: Denosumab Only Product<br>* denosumab subcutaneous injection /6 months, twice a year<br>* Other names: Denosumab;|
| Placebo Comparator: placebo control<br>Placebo subcutaneous injection /6 months, twice a year | Drug: Denosumab Only Product<br>* denosumab subcutaneous injection /6 months, twice a year<br>* Other names: Denosumab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| age | participants age (year) | up to 12 months | 
| sex | participants sex | up to 12 months | 
| height | participants height cm | up to 12 months | 
| weight | participants weight kg | up to 12 months | 
| BMI | participants body mass index | up to 12 months | 
| osteocalcin | osteocalcin in the N terminal molecular fragment | up to 12 months | 
| Procollagen type 1 n-terminal propeptide P1NP | Procollagen type 1 n-terminal propeptide | up to 12 months | 
| 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 | 
| parathyroid hormone | serum parathyroid hormone level | up to 12 months | 
| albumin | serum albumin 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 | Dual energy X-ray for hip bone mineral density | up to 12 months | 
| MRI of 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, with 0 being painless and 100 being the worst pain imaginable. | 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 | up to 12 month | 
| EuroQol-5D (EQ-5D): an instrument for measuring quality of life | 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 |