postmenopausal osteoporosis
Conditions
Interventions
experimental group:Take Jin Tian Ge Capsules (National Drug Approval Number Z20030080, 0.4g per capsule, containing 65mg of amino acids, 55mg of calcium, and 35mg of phosphorus
3 capsules per dose, 3 times per day) + Calcium Tablets Simulation Medicine (600 mg per day) + Alfacalcidol Soft Capsules (National Drug Approval Number H19991114, 0.25 µg per capsule, aVD3, 1 capsule
control group:Take Jin Tian Ge Capsules (National Drug Approval Number Z20030080, 0.4g per capsule, containing 65mg of amino acids, 55mg of calcium, and 35mg of phosphorus
3 capsules per dose, 3 times a day) as a control group + calcium tablets (600 mg per day) + Alfacalcidol Soft Capsules (National Drug Approval Number H19991114, 0.25 µg per capsule, aVD3, 1 capsule pe
Sponsors
The First Affiliated Hospital of Zhejiang University of Chinese Medicine (Zhejiang Provincial Hospital of Chinese Medicine)
Eligibility
Sex/Gender
Female
Age
45 Years to 80 Years
Inclusion criteria
Inclusion criteria: Those who meet all the following conditions can be included in the study group: 1) Female, aged over 45 years old, with natural menopause for = 1 year; if the menopause duration is unknown, an age of over 60 years old can be regarded as postmenopausal status; 2) Comply with the relevant diagnostic criteria of "Primary Osteoporosis Diagnosis Standards (Chinese Medical Association, 2022)"; 3) BMI ranging from 18.5 to 28.0 kg/m².
Exclusion criteria
Exclusion criteria: Those who meet any of the following conditions will be excluded: 1) Secondary osteoporosis, such as primary hyperparathyroidism, rheumatoid arthritis, multiple myeloma, bone tuberculosis, malignant bone tumors, etc.; 2) Those with severe underlying diseases that are poorly controlled (such as diabetes, hypertension, hyperphosphatemia, etc.); 3) Those who have used drugs that affect vitamin D metabolism in the past 3 months, or have used hormone drugs (such as estrogen preparations, selective estrogen receptor modulators, calcitonin, fluoride, synthetic glucocorticoids, parathyroid hormone, etc.) in the past 6 months, or have used bisphosphonate drugs in the past 12 months; 4) Those who have a history of lower limb fractures or have undergone lower limb surgery; 5) Those with abnormal lower limb alignment, including but not limited to genu varum, genu valgum, significant foot arch abnormalities, etc.; 6)Those with a difference in lower limb length of more than 1 cm; 7)Those with bone and muscle diseases or lower limb functional disorders, such as hemiplegia, amputation, severe visual impairment, etc., which affect gait.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gait spatiotemporal parameters;Plantar biomechanics; | — |
Secondary
| Measure | Time frame |
|---|---|
| Falls and new fractures incidents;Bone metabolism markers; | — |
Countries
the People's Republic of China
Contacts
Public ContactJunjie Li
The First Affiliated Hospital of Zhejiang University of Chinese Medicine (Zhejiang Provincial Hospital of Chinese Medicine)
Outcome results
None listed