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Evaluation and Optimization of Standardized Programs of Traditional Chinese Medicine for Prevention and Treatment of Osteoporosis

Evaluation and Optimization of Standardized Programs of Traditional Chinese Medicine for Prevention and Treatment of Osteoporosis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052834
Enrollment
Unknown
Registered
2021-11-06
Start date
2021-07-27
Completion date
Unknown
Last updated
2022-08-23

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

Conditions

osteoporosis

Interventions

Basic therapy group:Calcium + Vitamin D
Positive control group:Calcium + Vitamin D+Fosamax
Traditional Chinese Medicine Therapy Group:Calcium + Vitamin D+Chinese medicine dialectical prescription
Integrated Chinese and Western medicine therapy group:Calcium + Vitamin D+Fosam+Chinese medicine dialectical prescription

Sponsors

The First Affiliated Hospital of Jinan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Refer to the standard recommended by the World Health Organization (WHO): BMD is lower than the average normal value of young adults by more than 2.5 SD, and the following selection criteria are specified based on China's situation: 1. Adopt -2.0 SD recommended by the Osteoporosis Committee of the Chinese Society of Gerontology (OCCGS) or a 25% reduction in bone mass and/or fragility fractures of the hip or cone as the diagnostic criteria; 2. Aged >= 45 years, with spontaneous low back pain or/and weight-bearing pain, short body, hunched back. 3. Use dual-energy X-ray BMD instrument (Hologic QDR+2000) for inspection. At least one part of the lumbar spine or upper femur has a BMD lower than the peak BMD of normal young people of the same sex by 2.5 SD. The anatomical structure of the lumbar spine is suitable for dual-energy X-ray BMD In measurement, there was no obvious scoliosis or more than one compression fracture of the lumbar vertebral body.

Exclusion criteria

Exclusion criteria: 1. Patients with secondary osteoporosis; 2. Patients with serious diseases of the heart, liver, kidney, and hematopoietic system and their dysfunction, and mental patients; 3. Those who are participating in other drug trials; 4. Allergic, have a history of drug allergies or are known to have experimental drug components Allergic.

Design outcomes

Primary

MeasureTime frame
BMD;Phosphorus;Serumcalcium;Clinical Symptom Grading Table;TCM Syndrome Efficacy Evaluation Table;Primary Osteoporosis PRO Scale;SF-36 Survival Scale;

Secondary

MeasureTime frame
BALP;PINP;TRACP;ß-CTX;

Countries

China

Contacts

Public ContactZhang Ronghua

Ji'nan University

tzrh@jnu.edu.cn+86 20-85220007

Outcome results

None listed

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