Senile Osteoporosis
Conditions
Interventions
Denosumab group:NA
Teriparatide group:NA
Sponsors
Nanjing Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
70 Years to 95 Years
Inclusion criteria
Inclusion criteria: 1.Age>= 70years old. 2.Meets the diagnostic criteria for osteoporosis (fulfilling any one of the following three conditions:Fragility fracture of the hip or vertebral body; DXA measurement of femoral neck, lumbar spine, or total hip bone mineral density with a T-score <= -2.5; Bone density measurement indicates reduced bone mass (-2.5 < T-score < -1.0) plus fragility fracture at one or more sites including the proximal humerus, lumbar spine, pelvis, or distal forearm; 3.Deemed by the clinical physician to require anti-osteoporosis treatment with Denosumab or Teriparatide. 4.Agree to participate in this study and sign the informed consent form;
Exclusion criteria
Exclusion criteria: 1.Diagnosed with secondary osteoporosis; 2.Have used Denosumab or Teriparatide within the past 1 year; 3.Have used oral bisphosphonates within the past 3 months, and have a history of intravenous bisphosphonate use within the past 3 years; 4.Have used calcitonin drugs within the past 3 months, such as Calcitonin injection, Salmon Calcitonin injection, Salmon Nasal Calcitonin spray, patients with Salmon Calcitonin nasal spray; 5.Severe renal insufficiency, eGFR <= 30 mL/min/1.73 m^2; 6.Severe heart failure: Patients with NYHA Class IV; 7.Active liver disease or severe liver dysfunction; 8.HIV patients; 9.Long-term use of corticosteroids or immunosuppressants, and patients who have received organ transplants; 10.Patients with malignant tumors; 11.Patients allergic to any ingredient in Denosumab or Teriparatide; 12.Patients with Parkinson's disease or a history of stroke or cerebral hemorrhage within the past 3 months; 13.Unable to communicate normally or have severe visual, auditory impairments, etc., which prevent cooperation in completing cognitive function tests; 14.Diagnosed with schizophrenia, depression, or other mental illnesses; 15.Have taken anti-dementia drugs within the last 6 months, cholinesterase inhibitors such as Donepezil, Rivastigmine, Galantamine, Huperzine A, etc.; glutamate receptor antagonists such as Memantine; antipsychotic drugs such as Risperidone, Olanzapine, Quetiapine, etc.; anti-anxiety and antidepressant drugs such as Paroxetine, Fluoxetine, Sertraline, Citalopram, Trazodone; disease-modifying drugs (Aß protein clearance drugs, i.e., ATT class) such as Donanemab, Lecanumab; gut-brain axis inhibitors like Sodium Glycerate (GV-971); or have a history of sedative and hypnotic drug use within the last 6 months such as benzodiazepines, barbiturates, and have reported severe somnolence symptoms; 16.The patient or family members refuse to participate in the study; 17.Patients with severe fractures before medication and long-term bedridden loss of self-care ability, except for stable and non-progressive intervention measures in old fractures; 18.Other situations deemed unsuitable for participation in this study by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitive function MMSE score;The change in quality of life SF-36 score compared to the baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in cognitive function MMSE score compared to the baseline;The change in cognitive function MoCA score compared to the baseline;The change in cognitive function ASAD-cog score compared to the baseline;The change in bone mineral density compared to the baseline;The change in serum bone-derived factors compared to the baseline;The change in bone turnover markers [Type I collagen amino-terminal propeptide (P1NP), osteocalcin (OC), and C-telopeptide of Type I collagen (CTX)] compared to the baseline.;The differences in bone mineral density changes and cognitive function improvements between the Denosumab cohort and the Teriparatide cohort populations;All treatment-emergent adverse events (TEAE);The incidence of drug-related adverse reactions (ADR) and serious adverse events (SAE);Adverse events of special interest (AESI); | — |
Countries
China
Contacts
Public ContactQing Jiang
Nanjing Drum Tower Hospital
Outcome results
None listed