Clinical trial NCT05370898: The Study of Chinese Medicine for the Treatment of Primary Osteoporosis
Official title: Clinical Study of Bugu Shengsui Decoction for the Treatment of Primary Osteoporosis (Kidney Yang Deficiency Syndrome)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Osteoporosis
Keywords: Traditional Chinese medicine intervention
Completely randomized controlled trial
Double blind method clinical trial
Efficacy evaluation
Mechanism research
Lead sponsor: Wangjing Hospital, China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2022-05-12
Enrollment: 120
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and possible mechanism of traditional Chinese medicine in the treatment of primary osteoporosis (Kidney Yang Deficiency Syndrome).It is a randomized, placebo-controlled trial.

Detailed description: The subjects are selected according to the inclusion criteria and exclusion criteria. Using the network random system, 120 subjects who meet the research criteria are randomly divided into control group and experimental group, with 60 cases in each group. Patients in treatment group take the granule of traditional Chinese medicine prescription, while the control group take simulate granule of the prescription. Both two groups are under symptomatic treatment. Twice a day, in the morning and evening, 30 minutes after meals.The experimental drugs were provided by the pharmacy department of Wangjing hospital, Chinese Academy of traditional Chinese medicine, and the course of treatment was 3 months.The observation time points were before treatment, 2 weeks after treatment, 1 month after treatment and 3 months after treatment. Visual Analogue Score (VAS), Traditional Chinese Medicine（TCM）syndrome score, SF-12 scale and bone metabolism index were used as observation indexes.At the same time, it is planned to determine EphrinB2, EphB4, Runx2 and VEGF in serum by ELISA.

Tele-medicine and information management system is established to help achieve follow-up interviews.Random numbers are generated by SAS 9.4 software. The subjects, caregivers, investigators and outcomes assessors in this study are all blinded.

Eligibility criteria: Inclusion Criteria:

1. It meets the diagnostic criteria of Western medicine for primary osteoporosis. the diagnostic criteria of osteoporosis based on the bone mineral density of central axis (lumbar spine 1-4, femoral neck or total hip) or 1/3 bone mineral density of distal radius measured by DXA is t-value ≤ - 2.5;
2. It meets the syndrome differentiation standard of primary osteoporosis with Kidney Yang Deficiency Syndrome;
3. Female menopause \> 2 years and 45 years ≤ age \< 80 years, or 50 years ≤ male \< 80 years;
4. Visual Analogue Score (VAS) was used to evaluate pain ≥ 4 points;
5. Voluntarily participate in this clinical study and sign the informed consent form.

Exclusion Criteria:

1. Osteoporotic fracture has occurred, or t-value \> - 2.5;
2. Female premenopausal or menopausal years ≤ 2 years, female age \< 45 years or ≥ 80 years, male age \< 50 years or ≥ 80 years;
3. VAS pain score \< 4;
4. Lumbar fusion or severe degenerative changes hinder the measurement of normal bone mineral density, and there are less than 2 consecutive intact lumbar vertebrae for DXA measurement and evaluation;
5. Patients with malignant tumor, cardiovascular, cerebrovascular, liver disease, kidney disease, hematopoietic system and other serious primary diseases;
6. secondary osteoporosis: diabetes, thyroid disease, Cushing syndrome and other metabolic diseases, rheumatoid arthritis, multiple myeloma, gout, absorption syndrome, systemic lupus erythematosus and other systemic diseases.
7. Use drugs affecting bone metabolism, such as bisphosphonates, glucocorticoids, calcitonin, anticonvulsant drugs, heparin and other drugs within 3 months before signing the informed consent;
8. History of serious mental illness or poor compliance;
9. Allergic constitution, allergy to known components of the drug, allergy to calcium or vitamin D;
10. Those who participated in other clinical trials within 3 months.

Rejection Criteria:

1. False diagnosis and false inclusion;
2. Not receiving one treatment;
3. During the study, in addition to the study medication, drugs known or likely to affect bone metabolism were used.

Shedding Standard:

1. The subjects withdrew from the test by themselves;
2. Loss of follow-up;
3. The subject received treatment at least once, and there were serious complications or complications and serious adverse events;
4. Although the test was completed, the dosage of the subject was not within the range of 80%-120% of the dosage that should be taken.

Primary outcomes:
measure: Change of VAS pain score of low back
timeFrame: Change from baseline VAS score at 2 weeks.
measure: Change of VAS pain score of low back
timeFrame: Change from baseline VAS score at 1 month.
measure: Change of VAS pain score of low back
timeFrame: Change from baseline VAS score at 3 months.
measure: Change of Traditional Chinese medicine (TCM) syndrome score
timeFrame: Change from baseline TCM syndrome score at 2 weeks.
measure: Change of Traditional Chinese medicine (TCM) syndrome score
timeFrame: Change from baseline TCM syndrome score at 1 month.
measure: Change of Traditional Chinese medicine (TCM) syndrome score
timeFrame: Change from baseline TCM syndrome score at 3 months.
measure: Change of 12-Item Short Form Survey (SF-12) score
timeFrame: Change from baseline SF-12 score at 1 month.
measure: Change of 12-Item Short Form Survey (SF-12) score
timeFrame: Change from baseline SF-12 score at 3 months.
measure: Changes of serum bone metabolic indexes
timeFrame: Change from baseline bone metabolism index at 3 months.
measure: Changes of serum ALP
timeFrame: Change from baseline ALP at 3 months.
measure: Changes of serum BGP
timeFrame: Change from baseline BGP at 3 months.
measure: Changes of serum 25OHD
timeFrame: Change from baseline 25OHD at 3 months.
Secondary outcomes:
measure: Therapeutic mechanism
timeFrame: Change from baseline at 3 months.
Other outcomes:
measure: Blood routine tests
timeFrame: Up to 3 months.
measure: Electrocardiogram
timeFrame: Up to 3 months.
measure: Blood urea nitrogen
timeFrame: Up to 3 months.
measure: Serum creatinine
timeFrame: Up to 3 months.
measure: Liver function
timeFrame: Up to 3 months.
measure: Adverse events
timeFrame: Up to 3 months.
Locations:
city: Beijing
country: China
facility: Wangjing Hospital of China Academy of Chinese Medical Sciences
Study officials:
affiliation: Wangjing Hospital of China Academy of Chinese Medical Sciences
name: Xu Wei, Ph.D
role: STUDY_DIRECTOR
affiliation: Wangjing Hospital of China Academy of Chinese Medical Sciences
name: Ning Liu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: