Osteoporosis
Conditions
Interventions
Initial Treatment Experimental Group:Alendronate (70mg/week) + Qiqigu Capsules (3 pills/time, three times daily)
Initial Treatment Control Group 1:Alendronate (70mg/week) + Qiqigu Capsules placebo (3 pills/time, three times daily)
Initial Treatment Control Group 2:Qiqigu Capsules (3 pills/time, three times daily) + Alendronate placebo (70mg/week)
Long-term Treatment Experimental Group:Alendronate (70mg/week) + Qiqigu Capsules (3 pills/time, three times daily)
Long-term Treatment Control Group:Alendronate (70mg/week) + Qiqigu Capsules placebo (3 pills/time, three times daily)
Sponsors
Shenzhen Luohu Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: The inclusion criteria are based on a dual diagnostic framework integrating Western and Traditional Chinese Medicine (TCM) standards, targeting postmenopausal female osteoporosis patients aged 50-80 years. Western medicine diagnosis requires confirmation by dual-energy X-ray absorptiometry (DXA) with a lumbar or hip T-score = -2.5, or a history of vertebral fragility fractures, while excluding secondary osteoporosis and other confounding factors (e.g., metabolic disorders, long-term glucocorticoid use). TCM syndrome differentiation must align with liver-kidney deficiency patterns as per the "Guidelines for Clinical Research of New Chinese Medicines," characterized by symptoms such as lumbar pain, limited mobility, pale tongue with white coating, and quantified using a simplified McGee scale for symptoms like waist-knee soreness and lower limb weakness (graded as mild, moderate, or severe). Participants must provide informed consent and adhere to basic supplementation (daily calcium 500 mg and vitamin D 800 IU). Subjects are stratified into an initial treatment group (no prior bisphosphonate use) or a long-term medication group (alendronate use =3 years with signs of drug resistance) to ensure population representativeness.
Exclusion criteria
Exclusion criteria: The exclusion criteria are established based on safety and data integrity considerations, encompassing various clinical conditions. Specifically, patients with esophageal dysfunction (e.g., stenosis or reflux disease) are excluded to mitigate alendronate-associated gastrointestinal risks; those with renal insufficiency indicated by a creatinine clearance rate (Ccr) below 35 mL/min ensure metabolic safety; individuals with a history of hypersensitivity to the study drugs (Qiqigu Capsules or alendronate); subjects diagnosed with malignant tumors (active or history) to eliminate confounding effects on bone metabolism; and patients who have recently (e.g., within 3 months) used other anti-osteoporosis medications (e.g., bisphosphonates, RANKL inhibitors) or glucocorticoids. Additionally, individuals planning pregnancy, those with severe cardiovascular or cerebrovascular diseases, or patients unable to comply with follow-up are excluded to maintain cohort homogeneity and ethical compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in lumbar spine/hip BMD;Serum C-terminal telopeptide of type I collagen;Serum N-terminal propeptide of type I procollagen;Traditional Chinese Medicine Syndrome Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of fractures;Alanine Aminotransferase; | — |
Countries
China
Contacts
Public ContactDonghong Huang
Department of Orthopedics and Traumatology, Shenzhen Luohu Hospital of Traditional Chinese Medicine
Outcome results
None listed