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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Denosumab | Experimental | 1 ml (60 mg) of denosumab (Prolia; Amgen, Inc) subcutaneous injection plus intravenous placebo every 6 months |
|
| zoledronate | Active Comparator | Intravenous zoledronic acid 5 mg plus subcutaneous placebo every 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Denosumab Injection | Drug | 1 ml (60 mg) of denosumab (Prolia; Amgen, Inc) subcutaneous injection plus intravenous placebo every 6 months (Q6M) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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:
Must be age between 50 and 90 years old
Exclusion Criteria:
Must be able to have no intervertebral fissure
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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 |
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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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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.
| Zoledronate | Drug | Intravenous zoledronic acid 5 mg plus subcutaneous placebo every 12 months |
|
|
| 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 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). | 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 |
| 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 |