osteoporosis
Conditions
Interventions
Case series:None
Sponsors
Xi'an Honghui Hospital
Eligibility
Sex/Gender
Female
Age
50 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1) Age = 50, = 85 years old 2) Postmenopausal women, defined as spontaneous amenorrhea>2 years or bilateral oophorectomy>2 years 3)Lumbar or hip BMD: -4.0<T = -2.5; 4) New onset brittle fracture, defined as a fracture that occurs within 3 months and is caused by non violent or mild violence during daily activities or minor trauma (falling from standing or below), including vertebral fractures and non vertebral fractures 5) Plan to receive anti osteoporosis treatment with desuvumab 6) Voluntary signing of informed consent form
Exclusion criteria
Exclusion criteria: 1) Having diseases that can affect bone metabolism: various metabolic bone diseases (such as osteomalacia or osteogenesis imperfecta; Paget's disease, Cushing's syndrome, hyperprolactinemia, hypopituitarism, acromegaly, multiple myeloma), severe digestive tract diseases (including long-term chronic diarrhea), severe liver dysfunction (ALT or AST>3ULN), renal insufficiency, autoimmune diseases (such as rheumatoid and ankylosing spondylitis), thyroid and parathyroid diseases, unsatisfactory control of diabetes (glycosylated hemoglobin level>8.0%), and secondary osteoporosis caused by drugs 2) Hypothyroidism or hyperthyroidism, in which hypothyroidism subjects who have only received stable thyroid hormone replacement therapy can be selected based on the following criteria: a) If the TSH level is below the local normal range, the subjects cannot participate in the study. b) If TSH levels increase (>5.5 µ IU/mL but = 10.0 µ IU/mL, but serum FT4 is within the normal range, subjects can be selected. If the serum FT4 is not within the normal range, the subjects cannot participate in the study. c) If the TSH level is greater than 10.0 µ IU/mL, subjects cannot participate in the study. 3) Malignant tumor: Active malignant tumor (excluding completely excised in situ basal cell or squamous cell carcinoma, cervical cancer or ductal carcinoma of the breast) before signing the informed consent form. 4) Evidence of past or current osteomyelitis or necrosis of the jawbone; Acute dental or jawbone disease requiring oral surgery; Plan for invasive dental surgery; Dental or oral surgery has not healed. 5) Using active vitamin D or calcitonin within the first 3 months of enrollment; Received parathyroid hormone or PTH analogue 6 months prior to enrollment; Desuvumab, Teripaptide, Romosozumab or its analogues; Used bisphosphonates 24 months prior to enrollment 6) Participating in other clinical trials 7) Severe violence induced fractures 8) This fracture is a new finger (toe) fracture or a new craniofacial fracture. 9) There are contraindications related to the use of anti osteoporosis drugs, such as hypocalcemia; Severe renal insufficiency (glomerular filtration rate<30ml/min), etc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of secondary fractures in 12 months;Adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of secondary vertebral fractures within 12 months;Rate of secondary hip fractures within 12 months;Rate of secondary fractures at other sites within 12 months;Levels of bone turnover marker at 3, 6 and 12 months;Levels of bone metabolic markers at 3, 6 and 12 months;Bone mineral density at 12 months; | — |
Countries
China
Contacts
Public ContactZeng Yuhong
Xi'an Honghui Hospital
Outcome results
None listed