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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Denosumab | Experimental | Denosumab 60 mg were injected subcutaneously every 6 months (Q6M) |
|
| Placebo | Placebo Comparator | Equal volume of saline (0.9%) as placebo were injected subcutaneously every 6 months (Q6M) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Denosumab 60 mg/ml [Prolia] | Drug | denosumab subcutaneously every 6 months (Q6M) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Procollagen type 1 n-terminal propeptide (P1NP) | Bone formation marker, P1NP were determined at baseline, 6 and 12 months after surgery. | up to 12 months |
| C-terminal cross-linked type 1 collagen terminal peptide (CTX) | Bone resorption marker, CTX were determined at baseline, 6 and 12 months after surgery | up to 12 months |
| 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. | up to 12 months |
| Total hip BMD | Total hip BMD were determined at baseline, 6 and 12 months via dual-energy X-ray. | up to 12 months |
| Femoral neck BMD | Femoral neck BMD were determined at baseline, 6 and 12 month via dual-energy X-ray | up to 12 months |
| 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. | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 12 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiao Xiao, Doctor | Shenzhen People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ShenzhenPH | Shenzhen | Guangdong | 518000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33305593 | Result | 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. | |
| 26070551 | Result | 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. |
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| ID | Term |
|---|---|
| D000069448 | Denosumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Placebo | Drug | placebo subcutaneously every 6 months (Q6M) |
|
|
| 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. | up to 12 month |
| 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). | up to 12 month |
| 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. | up to 12 month |
| 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. | up to 12 month |
| 26687949 | Result | 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. |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |