Primary osteoporosis
Conditions
Interventions
Monotherapy group:Only accept denosumab combined with basic therapy.
Combination Therapy Group:Acceptance of Zhuanggu Zutong Capsules in combination with denosumab and basic treatment.
Sponsors
Yingtan City People's Hospital
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: Participants should be between 50 and 80 years old, regardless of gender; meet the diagnostic criteria for primary osteoporosis in the "Guidelines for Primary Care Diagnosis and Treatment of Primary Osteoporosis," namely, exhibiting typical symptoms such as weakness in walking, hunchback, soreness and weakness in the lower back and knees, and cold pain in the lower back and knees, and have a T-score = -2.5 as shown by dual-energy X-ray absorptiometry (DXA); meet the diagnostic criteria for liver and kidney deficiency syndrome in the "Expert Consensus on the Prevention and Treatment of Primary Osteoporosis with Traditional Chinese Medicine" according to TCM diagnosis; have complete baseline data, including demographic information, medical history, and relevant examination results; be willing to participate in this study and sign an informed consent form; and be able to cooperate in completing treatment and follow-up.
Exclusion criteria
Exclusion criteria: Patients diagnosed with secondary osteoporosis, i.e., osteoporosis caused by definite factors such as endocrine disorders, kidney disease, or long-term use of drugs affecting bone metabolism; patients who have received denosumab or bone-strengthening pain relief capsules within the past 6 months, which may affect the efficacy assessment of this study; patients allergic to bone-strengthening pain relief capsules, denosumab, or any component of their preparations; patients with serious primary diseases of the heart, liver, kidneys, hematopoietic system, etc., or with mental illness, making it impossible to cooperate with the study; patients with poor compliance, who, according to the investigator's assessment, cannot complete the prescribed treatment and follow-up as required by the protocol; and female patients who are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall clinical efficacy rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time of symptom improvement;Traditional Chinese Medicine Syndrome Scoring;Pain score;Bone Density;IL-6;TNF-a;lumbar function;Osteoporosis Knowledge;Safety Index; | — |
Countries
China
Contacts
Public ContactZhao Min
Yingtan City People's Hospital
Outcome results
None listed