Primary OsteoporosisNCT05370898
The Study of Chinese Medicine for the Treatment of Primary Osteoporosis
A study testing Caltrate D and Chinese medicine prescription in people with Primary Osteoporosis, run by Wangjing Hospital, China Academy of Chinese Medical Sciences at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Primary Osteoporosis
- What is being tested?
- Caltrate D and Chinese medicine prescription
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 1 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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:
- False diagnosis and false inclusion;
- 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;
- Loss of follow-up;
- The subject received treatment at least once, and there were serious complications or complications and serious adverse events;
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Wangjing Hospital of China Academy of Chinese Medical Sciences
Beijing
About this study
Official title: Clinical Study of Bugu Shengsui Decoction for the Treatment of Primary Osteoporosis (Kidney Yang Deficiency Syndrome)
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.
Read the 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.
- Conditions
- Primary Osteoporosis
- Being tested
- Caltrate D, Chinese medicine prescription, Placebo
- Keywords
- Traditional Chinese medicine intervention, Completely randomized controlled trial, Double blind method clinical trial, Efficacy evaluation, Mechanism research
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caltrate DDrug
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.
Chinese medicine prescriptionDrug
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.
PlaceboDrug
The placebo is simulate granule of Chinese medicine application prescription. Patients take 200ml each time, twice a day. Treatment duration are 3 months.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Caltrate D; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline 25OHD at 3 months.
Secondary outcomes (1)
Therapeutic mechanism
Serum level of EphrinB2, EphB4, Runx2 and VEGF in μg/mL，which is determined by enzyme linked immunosorbent assay（ELISA）.The higher the value, the better the bone condition. So as to verify the mechanism of Bugu Shengsui decoction.
Measured: Change from baseline at 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start1 Jul 2022 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wangjing Hospital, China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xu Wei, Ph.D, Study director, Wangjing Hospital of China Academy of Chinese Medical SciencesNing Liu, Ph.D, Principal investigator, Wangjing Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370898
- Sponsor's protocol ID
- ZZ13-YQ-039
- Status last verified
- May 2022
- First submitted
- 13 Apr 2022
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Bugu Shengsui Decoction for the Treatment of Primary Osteoporosis (Kidney Yang Deficiency Syndrome)
- ClinicalTrials.gov ID
- NCT05370898
- Acronym / sponsor ID
- ZZ13-YQ-039
- Conditions
- Primary Osteoporosis
- Keywords
- Traditional Chinese medicine intervention, Completely randomized controlled trial, Double blind method clinical trial, Efficacy evaluation, Mechanism research
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Wangjing Hospital, China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 12 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Chinese medicine | Experimental | Drug: Caltrate D, Drug: Chinese medicine prescriptionOn the basis of general symptomatic treatment of caltrate D，patients in experimental group use the traditional Chinese medicine application prescription. |
| Comparator: placebo | Placebo comparator | Drug: Caltrate D, Drug: PlaceboOn the basis of general symptomatic treatment of caltrate D，patients in placebo group use the simulate granule of traditional Chinese medicine application prescription. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caltrate DCaltrate D is allowed for basic treatment when the patient is diagnosed with primary osteoporosis (Kidney Yang Deficiency Syndrome).Take it continuously for 3 months. | Drug | Comparator: placebo, Traditional Chinese medicine |
| Chinese medicine prescriptionThe 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. | Drug | Traditional Chinese medicine |
| PlaceboThe placebo is simulate granule of Chinese medicine application prescription. Patients take 200ml each time, twice a day. Treatment duration are 3 months. | Drug | Comparator: placebo |
Primary outcome
Change of VAS pain score of low back
Time frame: Change from baseline VAS score at 2 weeks.
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 of VAS pain score of low back
Time frame: Change from baseline VAS score at 1 month.
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 of VAS pain score of low back
Time frame: Change from baseline VAS score at 3 months.
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 of Traditional Chinese medicine (TCM) syndrome score
Time frame: Change from baseline TCM syndrome score at 2 weeks.
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 of Traditional Chinese medicine (TCM) syndrome score
Time frame: Change from baseline TCM syndrome score at 1 month.
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 of Traditional Chinese medicine (TCM) syndrome score
Time frame: Change from baseline TCM syndrome score at 3 months.
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 of 12-Item Short Form Survey (SF-12) score
Time frame: Change from baseline SF-12 score at 1 month.
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 of 12-Item Short Form Survey (SF-12) score
Time frame: Change from baseline SF-12 score at 3 months.
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.
Changes of serum bone metabolic indexes
Time frame: Change from baseline bone metabolism index at 3 months.
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.
Changes of serum ALP
Time frame: Change from baseline ALP at 3 months.
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.
Changes of serum BGP
Time frame: Change from baseline BGP at 3 months.
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.
Changes of serum 25OHD
Time frame: Change from baseline 25OHD at 3 months.
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.
1 secondary outcome
Therapeutic mechanism
Time frame: Change from baseline at 3 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xu Wei, Ph.D study director
Wangjing Hospital of China Academy of Chinese Medical Sciences
Ning Liu, Ph.D principal investigator
Wangjing Hospital of China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caltrate D and Chinese medicine prescription in people with Primary Osteoporosis, run by Wangjing Hospital, China Academy of Chinese Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xu Wei, Ph.D (13488716557, weixu.007@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of VAS pain score of low back (time frame: Change from baseline VAS score at 2 weeks.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.