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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
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053953
Enrollment
Unknown
Registered
2021-12-04
Start date
2022-01-01
Completion date
Unknown
Last updated
2022-10-31

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 treatment
Experimental group:moxibustion treatment

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
40 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. In line with the 'Guidelines for the Diagnosis and Treatment of Primary Osteoporosis (2017)' formulated by the Osteoporosis and Bone Mineral Disease Branch of the Chinese Medical Association and issued by the American Academy of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE) in 2016 'Low bone mass' diagnosis in 'Clinical Practice Guidelines for the Diagnosis and Treatment of Postmenopausal Osteoporosis-2016'; 2. Aged 40 to 55 years, female; 3. Stop menstruation within 5 years; 4. The fracture risk assessment tool (FRAX) predicts a hip fracture probability < 3% and any major osteoporotic fracture probability < 20%; 5. Sign the informed consent and voluntarily participate in this experiment.

Exclusion criteria

Exclusion criteria: 1. Osteoporotic fractures have occurred; 2. Have used or are using anti-osteoporosis drugs (such as bisphosphonates, calcitonin, etc.); 3. Taking other drugs that affect bone metabolism (such as estrogen, glucocorticoid, etc.) in the past 3 months; 4. Abnormal lumbar spine or hip anatomy, unable to accurately measure bone mineral density using DXA test; 5. Suffering from secondary osteoporosis-related endocrine diseases (such as diabetes, hyperthyroidism, hypothyroidism, thyroid cyst, etc.); 6. Suffering from rickets, rheumatoid arthritis and other diseases affecting bone metabolism balance; 7. Those with hysterectomy or oophorectomy; 8. Patients with severe heart, liver, kidney, mental illness, etc.; 9. Drug or alcohol dependence or abusers; 10. Patients participating in other clinical trials.

Design outcomes

Primary

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

Secondary

MeasureTime frame
lumbar bone density;hip bone density;Bone turnover markers ;visual analog score (VAS) of bone pain;assessment of health-related quality of life;incidence of osteoporosis or fractures;usage of emergency drug or surgery related to bone loss;the participants self-evaluation of therapeutic effects;serum calcium, magnesium, phosphorus, parathyroid hormone (PTH) and 25-hydroxyvitamin D levels;

Countries

China

Contacts

Public ContactLu Lingyun

West China Hospital, Sichuan University

lingyun.lu@scu.edu.cn+86 18583955132

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 10, 2026