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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| denosumab | Experimental | Denosumab 60mg/6 months subcutaneously + placebo intravenous |
|
| zoledronic acid | Experimental | intravenous zoledronic acid and placebo /6 months subcutaneously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Denosumab | Drug | Denosumab 60mg/6 months subcutaneously + placebo iv |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongyu Wang, Doctor | Contact | 18241651300 | wanghongyu790039663@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ShenzhenPH | Recruiting | Shenzhen | Guangdong | 518000 | China |
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| ID | Term |
|---|---|
| D000069448 | Denosumab |
| D007279 | Injections, Subcutaneous |
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Zoledronic acid | Drug | Iv zoledronic acid and placebo /6 months subcutaneously |
|
|
| 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 |
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 |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |