Osteoporosis
Conditions
Interventions
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
Female
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 60 years; 2. Postmenopausal women; 3.Meet the diagnostic criteria for OP (meeting any one of the following three criteria): (1) History of a fragility fracture at the hip or spine; (2) BMD T-score 27 or a MoCA score > 18, and not requiring anti-dementia medication; 6. Agreement to participate in the study and provision of signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Diagnosed with secondary OP; 2. Prior use of denosumab or teriparatide within the last 6 months; 3. Prior use of oral bisphosphonates within the last 3 months, or history of intravenous bisphosphonate use within the past year; 4. Severe cardiac dysfunction; 5. History of myocardial infarction or stroke within the year prior to medication use; 6. Severe hepatic or renal impairment; 7. Current hypocalcemia or hypercalcemia; 8. Current unexplained elevation of alkaline phosphatase; 9. Long-term use of corticosteroids or immunosuppressants, or patients who have undergone organ transplantation; 10. Patients allergic to any component of romosozumab; 11. Inability to communicate normally verbally, or severe visual or hearing impairment preventing completion of cognitive function tests; 12. Diagnosis of schizophrenia, depression, or other psychiatric disorders; 13. Use of anti-dementia medications (e.g., cholinesterase inhibitors, glutamate receptor antagonists) within the last 6 months; use of antipsychotic medications (e.g., risperidone, olanzapine) within the last 6 months; use of anti-anxiety or antidepressant medications (e.g., paroxetine, fluoxetine, sertraline) within the last 6 months; or use of sedative-hypnotic medications (e.g., benzodiazepines, barbiturates) within the last 6 months, accompanied by severe drowsiness reported by the patient; 14. Patient or family refusal to participate in the study; 15. Any other condition deemed by the investigator as unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change from baseline in cognitive function assessed by the MMSE score at 12 months of Romosozumab treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in BMD;Change from baseline in bone turnover markers (including CTX, P1NP, OC, ALP);Change from baseline in quality of life assessed by the SF-36 score;Change from baseline in cognitive function assessed by the MoCA score;Change from baseline in osteokines; | — |
Countries
China
Contacts
Public ContactSong Chunli
Peking University Third Hospital
Outcome results
None listed