Postmenopausal osteoporosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Osteoporosis (diagnosed in accordance with World Health Organization standards); TCM syndrome classification which belongs to the syndrome of bone atrophy (main symptoms: sagging of the waist and spine, difficulty in walking; secondary symptoms: hair loss and tooth decay); 2) Female subjects conform to the age range of perimenopause to old age (45-70 years old), who have naturally stopped menstruation for more than one year; 3) No use of any drugs or intervention programs targeting PMOP within the six months prior to enrollment; 4) The inclusion criteria of this study require that the subjects meet the following ethical and research compliance conditions: one must independently decide to participate in the research, fully understand the research process and intervention measures, and independently sign a written informed consent document in terms of informed consent. Moreover, one must promise to complete all treatment plans and have good treatment compliance in terms of research compliance.
Exclusion criteria
Exclusion criteria: 1) Severe disruption of the normal anatomical structure of the lumbar spine (such as spinal curvature with a Cobb angle > 40°); 2) Suffering from endocrine and metabolic disorders that can lead to secondary PMOP (including abnormal glucose metabolism, thyroid dysfunction, etc.); 3) Having a history of hysterectomy or adnexectomy; 4) Comorbid with underlying diseases that disrupt the balance of bone metabolism (such as bone mineralization disorders, chronic arthritis, etc.); 5) Having a history of using drugs that interfere with bone remodeling within 3 months before enrollment (such as glucocorticoids, calcitonin, or estrogen); 6) Having major organ dysfunction (cardiovascular/liver/renal failure = III) or poorly controlled mental and neurological disorders (such as schizophrenia, severe depressive episode); 7) Drug or alcohol abuse; 8) Participants in multi-center trials; 9) Individuals with a history of drug sensitization or high sensitivity reaction characteristics.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Traditional Chinese Medicine Syndrome Score;Bone metabolism-related indicators;VAS score; | — |
Secondary
| Measure | Time frame |
|---|---|
| ODI score;Quality of Life Questionnaire of the European Foundation for Osteoporosis;weight;Short Physical Performance Battery score;bone mineral density;Indicators associated with endoplasmic reticulum stress;Indicators associated with autophagy;Proton density fat fraction; | — |
Countries
China
Contacts
Wenshan Zhuang and Miao Autonomous Prefecture General Hospital