Osteoporotic fracture of thoracolumbar spine
Conditions
Interventions
Experimental group (Group A):Disumab Injection
Control drug (Group B):zoledronic acid
Sponsors
Hebei Medical University Third Hospital
Eligibility
Sex/Gender
Female
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 50 years old; 2.Before the fracture, it can walk independently without any assistance (crutches, wheelchairs, etc.); 3.Postmenopausal women (spontaneous menopause lasting more than 1 year, if the status of bilateral oophorectomy is unknown, follicle stimulating hormone FSH >= 40IU/L confirmed menopausal status); 4.Fragile vertebral fractures occurred in the past month: vertebral fractures caused by low-energy external forces or daily activities, referred to as' low energy ' Measuring external force "is equivalent to the force generated by the human body falling from a standing height or below; 5.MRI shows high signal intensity of the injured vertebra; 6.X-ray examination shows vertebral compression fracture with vertebral height loss <= 1/2; 7.Be fully informed and sign an informed consent form;
Exclusion criteria
Exclusion criteria: 1.Patients allergic to mammalian cell-derived products or denosumab; 2.Exclude spinal fractures caused by pathological factors such as tumors and spinal tuberculosis; 3.Abnormal blood calcium: hypocalcemia or hypercalcemia, serum calcium or corrected albumin calcium = 2.9 mmol/L (11.5 mg/dL); 4.Creatinine clearance rate 1mm); Multiple fractures: fractures that occur in 2 or more locations; 6.Within the past 5 years, intravenous injection of bisphosphonates, fluoride, or strontium has been used; Oral bisphosphonates (used for >= 3 years, or Used for less than 3 years but more than 3 months, with the last use occurring within 1 year prior to signing the informed consent form; Within the past 6 weeks Using drugs that affect bone metabolism, such as parathyroid hormone (PTH) or PTH derivatives, such as teriparatide; Assimilatory hormones or testosterone Corticosteroids (equivalent to taking over 5 milligrams of prednisone per day for more than 10 days); Hormone replacement therapy; selectiveness Estrogen receptor modulators (SERMs), such as raloxifene; Calcitonin, calcitriol and other active vitamins D (calcitriol and other active vitamins) Shengsu D is allowed to be discontinued within 4 weeks before signing the informed consent form; Use other bone active drugs, such as anticonvulsant drugs (benzodiazepines) Except for Zhuo drugs or heparin; Long term systemic use of ketoconazole, adrenocorticotropic hormone (ACTH), cinacalcet, aluminum Lithium, protease inhibitors, methotrexate, gonadotropin-releasing hormone agonists, insulins, GLP-1 receptor agonists Thiazolidinediones. 7.Patients deemed unsuitable as subjects by other researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of lumbar spine bone mineral density from baseline to 12 months after treatment (relative percentage, %);; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in bone density of hip (trochanter, femoral neck, total hip) after 12 months of treatment;Improvement of VAS scores in patients treated for 6 and 12 months;Percentage of vertebral height loss after 12 months of treatment;The incidence and severity of adverse events (AEs), as well as clinically significant abnormal laboratory test results;Quality of Life Assessment (EQ-5D) at 6 and 12 Months of Treatment;Improvement in activity ability at 6 and 12 months of treatment (Oswestry Disability Index, ODI);Medical expenses for 12 months of treatment;The incidence of recurrent fractures after 12 months of treatment; | — |
Countries
China
Contacts
Public ContactHou Zhiyong
Hebei Medical University Third Hospital
Outcome results
None listed