postmenopausal osteopenia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Eligible participants should conform to diagnostic criteria of osteopenia in the AACE/ACE guidelines [6] and those who meet the following inclusion criteria will be included: 2) females aged 40 ~ 55 years; 3) women within 5 years of menopause; 4) the 10-year probability of hip fracture < 3% and any major osteoporotic fracture < 20% predicted by the fracture risk assessment tool (FRAX); 5) patients who agree to participate in this study and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients with osteoporotic fractures; 2) Patients who have used or are using anti-osteoporosis drugs (such as bisphosphonates, calcitonin, etc.); 3) Patients who have taken other drugs affecting bone metabolism (such as estrogen, glucocorticoid, etc.) in the last 3 months; 4) Patients who have abnormal anatomy of the lumbar spine or hip and the BMD cannot be accurately measured by DXA detection; 5) Patients who have endocrine diseases related to secondary osteoporosis (such as diabetes, hyperthyroidism, hypothyroidism, thyroid cysts, etc.); 6) Patients suffering from rickets, rheumatoid arthritis and other diseases affecting the balance of bone metabolism; 7) Patients with hysterectomy or ovariectomy; 8) Patients with serious heart, liver, kidney and mental diseases; 9) Patients with drug or alcohol dependence or abuse; 10) Patients participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BMD of the lumbar spine (L1-4); | — |
Secondary
| Measure | Time frame |
|---|---|
| BMD of the lumbar spine;the participants self-evaluation of therapeutic effects;visual analog score (VAS) of bone pain;incidence of osteoporosis or fractures;Bone turnover markers (ß- CTX, P1NP, and bone-specific alkaline phosphatase);usage of emergency drug or surgery related to bone loss;serum calcium, magnesium, phosphorus, parathyroid hormone (PTH) and 25-hydroxyvitamin D;BMD of the femoral neck and total hip;T-score of the lumbar spine, the femoral neck and total hip;assessment of health-related quality of life; | — |
Countries
China