Moxibustion as Adjuvant Therapy for Preventing Bone Loss in Postmenopausal Women: A Randomized Controlled Trial Protocol

Not Applicable

• Conditions: postmenopausal osteopenia

• Registration Number: ITMCTR2100005371
• Lead Sponsor: West China Hospital, Sichuan University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BMD of the lumbar spine (L1-4);

Secondary Outcome Measures

Name	Time	Method
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;