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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dnosumab | Experimental | Desuzumab 60 mg subcutaneously /6 months, twice a year |
|
| placebo control | Placebo Comparator | Placebo subcutaneous injection /6 months, twice a year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Denosumab Only Product | Drug | denosumab subcutaneous injection /6 months, twice a year |
|
| 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 |
| 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:• Must be age between 40 and 90 years old
Exclusion Criteria:
• Must be able to have no posterior vertebral wall fracture
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| Name | Affiliation | Role |
|---|---|---|
| Hongyu Wang, 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 |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| 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 |
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 |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |