The Study of Chinese Medicine for the Treatment of Primary Osteoporosis

NCT05370898 | Unknown DMC

• 1 other identifier: ZZ13-YQ-039
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Osteoporosis

Keywords

Traditional Chinese medicine intervention; Completely randomized controlled trial; Double blind method clinical trial; Efficacy evaluation; Mechanism research

Outcome Measures

Primary Outcomes (12)

• Change of VAS pain score of low back

  Draw a straight line with a length of 10 cm on the white paper and mark "painless" and "severe pain" on both ends respectively to form VAS. The patient makes a mark on the straight line according to the degree of pain he feels. The distance from the starting point to the mark is the quantified degree of pain. Painless is represented by 0; 1-3 points represent mild pain; 4-6 points represent moderate pain, which is strong but tolerable; 7-10 points represent severe pain, gradually reaching intolerable level, which is severe pain.

  Change from baseline VAS score at 2 weeks.

• Change of VAS pain score of low back

  Draw a straight line with a length of 10 cm on the white paper and mark "painless" and "severe pain" on both ends respectively to form VAS. The patient makes a mark on the straight line according to the degree of pain he feels. The distance from the starting point to the mark is the quantified degree of pain. Painless is represented by 0; 1-3 points represent mild pain; 4-6 points represent moderate pain, which is strong but tolerable; 7-10 points represent severe pain, gradually reaching intolerable level, which is severe pain.

  Change from baseline VAS score at 1 month.

• Change of VAS pain score of low back

  Draw a straight line with a length of 10 cm on the white paper and mark "painless" and "severe pain" on both ends respectively to form VAS. The patient makes a mark on the straight line according to the degree of pain he feels. The distance from the starting point to the mark is the quantified degree of pain. Painless is represented by 0; 1-3 points represent mild pain; 4-6 points represent moderate pain, which is strong but tolerable; 7-10 points represent severe pain, gradually reaching intolerable level, which is severe pain.

  Change from baseline VAS score at 3 months.

• Change of Traditional Chinese medicine (TCM) syndrome score

  According to the《expert consensus on the prevention and treatment of primary osteoporosis with reference to traditional Chinese medicine (2020)》, the quantitative evaluation table of TCM syndrome differentiation for osteoporosis with Kidney Yang Deficiency syndrome was formulated to evaluate the symptoms. Symptoms include primary and secondary symptoms, the primary symptoms were low back pain and soreness and weakness, the secondary symptoms include restricted movement of the lumbar spine，fear of cold and like to be warm，degree of frequency of urination. The primary symptom score was 0 (absent), 2 (mild), 4 (moderate), or 6 (marked)，the secondary symptom score was 0 (absent), 1 (mild), 2 (moderate), or 3 (marked).The obtained scores were summed to calculate the total score.

  Change from baseline TCM syndrome score at 2 weeks.

• Change of Traditional Chinese medicine (TCM) syndrome score

  According to the《expert consensus on the prevention and treatment of primary osteoporosis with reference to traditional Chinese medicine (2020)》, the quantitative evaluation table of TCM syndrome differentiation for osteoporosis with Kidney Yang Deficiency syndrome was formulated to evaluate the symptoms. Symptoms include primary and secondary symptoms, the primary symptoms were low back pain and soreness and weakness, the secondary symptoms include restricted movement of the lumbar spine，fear of cold and like to be warm，degree of frequency of urination. The primary symptom score was 0 (absent), 2 (mild), 4 (moderate), or 6 (marked)，the secondary symptom score was 0 (absent), 1 (mild), 2 (moderate), or 3 (marked).The obtained scores were summed to calculate the total score.

  Change from baseline TCM syndrome score at 1 month.

• Change of Traditional Chinese medicine (TCM) syndrome score

  According to the《expert consensus on the prevention and treatment of primary osteoporosis with reference to traditional Chinese medicine (2020)》, the quantitative evaluation table of TCM syndrome differentiation for osteoporosis with Kidney Yang Deficiency syndrome was formulated to evaluate the symptoms. Symptoms include primary and secondary symptoms, the primary symptoms were low back pain and soreness and weakness, the secondary symptoms include restricted movement of the lumbar spine，fear of cold and like to be warm，degree of frequency of urination. The primary symptom score was 0 (absent), 2 (mild), 4 (moderate), or 6 (marked)，the secondary symptom score was 0 (absent), 1 (mild), 2 (moderate), or 3 (marked).The obtained scores were summed to calculate the total score.

  Change from baseline TCM syndrome score at 3 months.

• Change of 12-Item Short Form Survey (SF-12) score

  The 12-Item Short Form Survey have 12 items and 8 dimensions, which are overall health, Physical Functioning, Role-Physical, Bodily Pain, Vitality, Social Functioning, Role-Emotional and Mental Health. The first four dimensions belong to the level of Physical Component Summary, and the last four dimensions belong to the level of Mental Component Summary. Each item was scored according to the corresponding options to evaluate the impact of health on an individual's everyday life. The highest score of item 2 and 3 is 3, and the lowest score is 1. The highest score of the other ten items is 5, and the lowest score is 1. The obtained scores were summed to calculate the total score to evaluate the changes of patients' quality of life.The higher the score, the better the quality of life.

  Change from baseline SF-12 score at 1 month.

• Change of 12-Item Short Form Survey (SF-12) score

  The 12-Item Short Form Survey have 12 items and 8 dimensions, which are overall health, Physical Functioning, Role-Physical, Bodily Pain, Vitality, Social Functioning, Role-Emotional and Mental Health. The first four dimensions belong to the level of Physical Component Summary, and the last four dimensions belong to the level of Mental Component Summary. Each item was scored according to the corresponding options to evaluate the impact of health on an individual's everyday life. The highest score of item 2 and 3 is 3, and the lowest score is 1. The highest score of the other ten items is 5, and the lowest score is 1. The obtained scores were summed to calculate the total score to evaluate the changes of patients' quality of life.The higher the score, the better the quality of life.

  Change from baseline SF-12 score at 3 months.

• Changes of serum bone metabolic indexes

  Serum level of Beta-CrossLaps (β-CTX) in ng/mL, N-terminal propeptide of type I procollagen (P1NP) in ng/mL，which are determined by Electrochemiluminescence Method.The normal reference ranges of serum P1NP and β-CTX are 16.3\~78.2 ng/mL and 0.114\~0.628ng/mL, respectively.In case of abnormal conditions,the higher the β-CTX, the more serious the bone resorption.The lower the P1NP, the less bone formation and the worse the bone condition.

  Change from baseline bone metabolism index at 3 months.

• Changes of serum ALP

  Serum level of Alkaline phosphatase (ALP) in U/L, which is determined by automatic biochemical analysis.The normal value is 40-150 U/L.When it is lower than the normal value, it indicates that bone formation is reduced.

  Change from baseline ALP at 3 months.

• Changes of serum BGP

  Serum level of bone glaprotein (BGP) in μg/L, which is determined by automatic biochemical analysis.The normal value is 4.8\~10.2 μg/L.When it is lower than the normal value, it indicates that bone formation is reduced.

  Change from baseline BGP at 3 months.

• Changes of serum 25OHD

  Serum level of 25-hydroxy vitamin D (25OHD) in nmol/ml，which is determined by Electrochemiluminescence Method. Its value ≥ 30 nmol/L is normal，it may appear osteoporosis if below this value.

  Change from baseline 25OHD at 3 months.

Secondary Outcomes (1)

• Therapeutic mechanism

  Change from baseline at 3 months.

Other Outcomes (6)

• Blood routine tests

  Up to 3 months.

• Electrocardiogram

  Up to 3 months.

• Blood urea nitrogen

  Up to 3 months.

Study Arms (2)

Traditional Chinese medicine

EXPERIMENTAL

On the basis of general symptomatic treatment of caltrate D，patients in experimental group use the traditional Chinese medicine application prescription.

Drug: Caltrate D; Drug: Chinese medicine prescription

Comparator: placebo

PLACEBO COMPARATOR

On the basis of general symptomatic treatment of caltrate D，patients in placebo group use the simulate granule of traditional Chinese medicine application prescription.

Drug: Caltrate D; Drug: Placebo

Interventions

Caltrate D DRUG

Caltrate D is allowed for basic treatment when the patient is diagnosed with primary osteoporosis (Kidney Yang Deficiency Syndrome).Take it continuously for 3 months.

Comparator: placebo; Traditional Chinese medicine

Chinese medicine prescription DRUG

The Chinese medicine application prescription is composed of Rhizoma Drynariae 12g, psoralen 10g, dog ridge 10g, medlar 10g, raw oyster 10g, ginseng 6g, Panax notoginseng 3g, Amomum villosum 6g.Patients take 200ml each time, twice a day. Treatment duration are 3 months.

Traditional Chinese medicine

Placebo DRUG

The placebo is simulate granule of Chinese medicine application prescription. Patients take 200ml each time, twice a day. Treatment duration are 3 months.

Comparator: placebo

Eligibility Criteria

• Age: 45 Years - 80 Years
• Gender Eligibility Details: Female：menopause \> 2 years and 45 years ≤ age \< 80 years Male：50 years ≤ male \< 80 years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• It meets the syndrome differentiation standard of primary osteoporosis with Kidney Yang Deficiency Syndrome;
• Female menopause \> 2 years and 45 years ≤ age \< 80 years, or 50 years ≤ male \< 80 years;
• Visual Analogue Score (VAS) was used to evaluate pain ≥ 4 points;
• Voluntarily participate in this clinical study and sign the informed consent form.

You may not qualify if:

• Osteoporotic fracture has occurred, or t-value \> - 2.5;
• Female premenopausal or menopausal years ≤ 2 years, female age \< 45 years or ≥ 80 years, male age \< 50 years or ≥ 80 years;
• VAS pain score \< 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;
• Patients with malignant tumor, cardiovascular, cerebrovascular, liver disease, kidney disease, hematopoietic system and other serious primary diseases;
• 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.
• Use drugs affecting bone metabolism, such as bisphosphonates, glucocorticoids, calcitonin, anticonvulsant drugs, heparin and other drugs within 3 months before signing the informed consent;
• History of serious mental illness or poor compliance;
• Allergic constitution, allergy to known components of the drug, allergy to calcium or vitamin D;
• Those who participated in other clinical trials within 3 months.
• Rejection Criteria:
• Not receiving one treatment;
• During the study, in addition to the study medication, drugs known or likely to affect bone metabolism were used.
• Shedding Standard:
• The subjects withdrew from the test by themselves;

Sponsors & Collaborators

• Wangjing Hospital, China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Wangjing Hospital of China Academy of Chinese Medical Sciences

Beijing, China

Location

Study Officials

• Xu Wei, Ph.D

  Wangjing Hospital of China Academy of Chinese Medical Sciences

  STUDY DIRECTOR

• Ning Liu, Ph.D

  Wangjing Hospital of China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xu Wei, Ph.D

CONTACT

13488716557; weixu.007@163.com

Ning Liu, Ph.D

CONTACT

15650071932; goat0707@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: May 12, 2022
• Study Start: July 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: May 1, 2023
• Last Updated: May 19, 2022

Record last verified: 2022-05

Locations

CN (1)