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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100005371
Enrollment
Unknown
Registered
2021-12-04
Start date
2022-01-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

postmenopausal osteopenia

Interventions

Control group:placebo-moxibustion control (PMC) group
Experimental group:moxibustion treatment (MT)

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
40 Years to 65 Years

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

MeasureTime frame
BMD of the lumbar spine (L1-4);

Secondary

MeasureTime 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

Contacts

Public ContactLingyun Lu
lingyun.lu@scu.edu.cn18583955132

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026