OVCF DatabaseNCT07321795
Osteoporotic Vertebral Compression Fracture Cohort Study
An observational study of OVCF Database and Cohort Study, run by Wangjing Hospital, China Academy of Chinese Medical Sciences at 4 sites in China.
Trial summary
The study aims to construct an early warning model for Osteoporotic Vertebral Compression Fracture (OVCF) by integrating TCM syndrome patterns with modern risk factors. This is a multi-center cohort study on OVCF integrated with disease and syndrome differentiation in Traditional Chinese Medicine (TCM). Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- OVCF Database, Cohort Study
- How many people
- 200 participants
- Where
- 4 sitesChina
- Study dates
- 10 Jan 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study participants are selected from patients admitted to four participating tertiary hospitals
Who may be able to join
- 1.50 years ≤ age < 80 years; gender includes both male and female. 2.Meet the diagnostic criteria for new-onset osteoporotic vertebral compression fracture.
- 3.Voluntarily participate in this clinical study and sign the informed consent form.
- Subjects meeting only criteria (1) and (3) with a T-score ≥ -1.0 can be included in the normal bone mass group. Subjects meeting criteria (1) and (3) with -2.5 < T-score < -1.0 can be included in the osteopenia group. Subjects meeting criteria (1) and (3) with T-score ≤ -2.5, meeting the diagnostic criteria for osteoporosis, can be included in the OP group. Subjects meeting all criteria (1), (2), and (3) will be included in the OVCF patient group.
Who cannot join
- Patients with serious concomitant cardiovascular/cerebrovascular diseases, liver/kidney diseases, malignant tumors, or other wasting diseases, and patients with infectious diseases.
- Patients with other endocrine system diseases, such as Cushing's syndrome, hyperthyroidism, hypothyroidism, etc.
- Patients who have participated in other clinical trials within the past 3 months.
- Patients with concomitant Alzheimer's disease, mental illnesses or depression, or those unable to cooperate to complete the trial.
- Patients with poor compliance
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites
Wangjing Hospital, China Academy of Chinese Medical Sciences
Beijing, 100102
Xu Wei, Ph.D, +8613488716557, weixu.007@163.com
The First Affiliated Hospital of Hunan University of Chinese Medicine
Hunan, Changsha, 410021
Shaofeng Yang, Ph.D, 13873148670, ysf574996585@163.com
Suzhou TCM Hospital Affiliated to Nanjing University of Chinese Medicine
Suzhou, Jiangsu, 215000
Jintao liu, Ph.D, 13584851171, okdoctor@163.com
Shandong Wendeng Orthopedic Hospital
Weihai, Shandong, 264400
Hongjiang Jiang, Ph.D, +8615895891872, boneman@163.com
About this study
Official title: Osteoporotic Vertebral Compression Fractures: A Multi-center Cohort Study Based on Disease and Syndrome Differentiation
The study aims to construct an early warning model for Osteoporotic Vertebral Compression Fracture (OVCF) by integrating TCM syndrome patterns with modern risk factors. This is a multi-center cohort study on OVCF integrated with disease and syndrome differentiation in Traditional Chinese Medicine (TCM).
Read the detailed description
The subjects are selected according to the inclusion criteria and exclusion criteria. A total of 200 subjects will be recruited from four participating tertiary hospitals and categorized into four groups: individuals with normal bone mass, osteopenia, osteoporosis, and Osteoporotic Vertebral Compression Fracture (OVCF) . Data collection encompasses three levels:
- Macro-level: Demographics, lifestyle, medical history, and physical metrics.
- Meso-level: TCM syndrome diagnoses, bone mineral density (BMD), MRI assessments, and functional scores (VAS, ODI).
- Micro-level: Serum biomarkers related to bone metabolism, lipids, inflammation, and muscle health.
Strict quality control measures will be implemented, including researcher training and data monitoring. The integrated database and analytical framework are designed to develop a practical, population-specific risk prediction tool for OVCF.
- Conditions
- OVCF Database, Cohort Study
- Keywords
- Osteoporotic Vertebral Compression Fractures, Traditional Chinese Medicine, Potential biomarkers, Risk prediction model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| normal bone mass group | Not described | |
| osteopenia group | Not described | |
| osteoporosis group | Not described | |
| Osteoporotic Vertebral Compression Fracture group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Mineral Density (BMD)
DXA will be used to measure lumbar spine (L1-L4) and bilateral hip density, recording the T-score for each site. Instrument precision will be set to 1% (i.e., repeated measurement error < 1%). Professionals will be responsible for post-use accuracy checks and maintenance.
Measured: Baseline
Secondary outcomes (31)
Muscle Strength
Left and right handgrip strength in kilograms, which is determined by a handheld dynamometer. The normal range varies by age, gender, and dominant hand. When it is lower than the normal range, it may indicate muscle weakness, sarcopenia, or neuromuscular disorders; when it is higher than the normal range, it typically reflects good musculoskeletal health and physical fitness.
Measured: Baseline
The bone marrow fat fraction (FF)
The bone marrow fat fraction (FF) of lumbar vertebrae (expressed as a percentage), which is determined by magnetic resonance imaging (MRI) analysis. The normal range varies with age and vertebral level, typically between 30-50% in healthy adults. When it is higher than the normal range, it may indicate osteoporosis, aging, or metabolic bone disease; when it is lower than the normal range, it may suggest conditions such as bone marrow edema, inflammation, or hematopoietic disorders.
Measured: Baseline
Paravertebral muscle area
The paravertebral muscle area (in cm²), which is determined by magnetic resonance imaging (MRI) analysis. The normal range varies based on vertebral level, age, and gender. When it is smaller than the normal range, it may indicate muscle atrophy, sarcopenia, or degenerative changes.
Measured: Baseline
Fatty infiltration
The degree of paravertebral muscle fatty infiltration (expressed as a percentage or fat fraction), which is determined by magnetic resonance imaging (MRI) analysis. The normal range varies with age and vertebral level. When it is higher than the normal range, it indicates increased intramuscular fat deposition, often associated with aging, disuse, or metabolic disorders.
Measured: Baseline
Vertebral bone quality (VBQ) score
The vertebral bone quality (VBQ) score, which is determined by magnetic resonance imaging (MRI) analysis. The normal range is 1.5-3.0. When it is higher than the normal range, it indicates poor bone quality and an increased risk of osteoporotic vertebral fractures; when it is lower than the normal range, it indicates better bone quality and a lower fracture risk.
Measured: Baseline
Visual Analogue Scale (VAS) Score
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. Draw a 10 cm long on a piece of white paper.
Measured: Baseline
Lumbar Oswestry Disability Index (ODI) Score
The ODI is a patient-reported questionnaire consisting of 10 sections (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling). Each section is scored from 0 to 5, with higher scores indicating greater disability. Interpretation of ODI Scores:0-20%: Minimal disability (can perform daily activities normally).21-40%: Moderate disability (pain and functional limitations affect some activities).41-60%: Severe disability (pain significantly restricts daily life).61-80%: Crippling disability (most activities are severely limited).81-100%: Bed-bound or exaggerated symptoms.
Measured: Baseline
OP TCM Syndrome Information
Four patterns including Kidney Yang Deficiency, Spleen-Kidney Yang Deficiency, Liver-Kidney Yin Deficiency, Kidney Deficiency with Blood Stasis. Two professional TCM clinicians will independently determine the patient's syndrome pattern. In case of disagreement, a third physician will adjudicate.
Measured: Baseline
OVCF TCM Syndrome Information
Four patterns including Qi Stagnation and Blood Stasis, Kidney Deficiency with Blood Stasis, Liver-Kidney Yin Deficiency. Two professional TCM clinicians will independently determine the patient's syndrome pattern. In case of disagreement, a third physician will adjudicate.
Measured: Baseline
Total Type I Procollagen N-terminal Propeptide (P1NP)、β-Cross-linked C-telopeptide of Type I Collagen (β-CTX)
Serum level of Beta-CrossLaps (β-CTX) in ng/mL, N-terminal propeptide of type l procollagen (P1NP) in ng/mL, which are determined by Electrochemiluminescence Method.The normal reference ranges of serum P1NP and ß-CTX are 16.3-78.2 ng/mL and 0.114-0.628 ng/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: Baseline
Serum bone glaprotein (BGP)
Serum level of bone glaprotein (BGP) in ug/L, which is determined by automatic biochemical analysis The normal value 48-10.2 ug/L.When it is lower than the normal value, it indicates that bone formation is reduced.
Measured: Baseline
25-Hydroxyvitamin D (25(OH)D)
Serum level of 25-Hydroxyvitamin D (25(OH)D) in nmol/L, which is determined by automatic biochemical analysis. The normal value is 50-125 nmol/L. When it is lower than the normal value, it indicates vitamin D deficiency or insufficiency.
Measured: Baseline
Intact Parathyroid Hormone (PTH)
Serum level of Intact Parathyroid Hormone (PTH) in pg/mL, which is determined by automatic biochemical analysis. The normal value is 15-65 pg/mL. When it is higher than the normal value, it may indicate hyperparathyroidism; when it is lower than the normal value, it may indicate hypoparathyroidism or vitamin D intoxication.
Measured: Baseline
Total Cholesterol (TC)
Serum level of Total Cholesterol (TC) in mmol/L, which is determined by automatic biochemical analysis. The normal value is <5.2 mmol/L. When it is higher than the normal value, it indicates an increased risk of cardiovascular disease; when it is lower than the normal value, it may be associated with malnutrition or liver dysfunction.
Measured: Baseline
Triglycerides (TG)
Serum level of Triglycerides (TG) in mmol/L, which is determined by automatic biochemical analysis. The normal value is <1.7 mmol/L. When it is higher than the normal value, it indicates hypertriglyceridemia and an increased risk of cardiovascular disease; when it is lower than the normal value, it may be associated with malnutrition or malabsorption.
Measured: Baseline
High-Density Lipoprotein Cholesterol (HDL-C)
Serum level of High-Density Lipoprotein Cholesterol (HDL-C) in mmol/L, which is determined by automatic biochemical analysis. The normal value is ≥1.0 mmol/L. When it is higher than the normal value, it indicates a lower risk of cardiovascular disease; when it is lower than the normal value, it indicates an increased risk of cardiovascular disease.
Measured: Baseline
Low-Density Lipoprotein Cholesterol (LDL-C)
Serum level of Low-Density Lipoprotein Cholesterol (LDL-C) in mmol/L, which is determined by automatic biochemical analysis. The normal value is <3.4 mmol/L. When it is higher than the normal value, it indicates an increased risk of cardiovascular disease; when it is lower than the normal value, it may be associated with genetic factors or liver dysfunction.
Measured: Baseline
Leptin
Serum level of Leptin in ng/mL, which is determined by automatic biochemical analysis. The normal value is 1.1-27.6 ng/mL. When it is higher than the normal value, it may indicate leptin resistance or obesity; when it is lower than the normal value, it may be associated with malnutrition or low body fat.
Measured: Baseline
Visfatin
Serum level of Visfatin in ng/mL, which is determined by automatic biochemical analysis. The normal value is 10-50 ng/mL. When it is higher than the normal value, it may indicate obesity, insulin resistance, or inflammatory conditions; when it is lower than the normal value, it may be associated with metabolic dysregulation.
Measured: Baseline
Apelin
Serum level of Apelin in pg/mL, which is determined by automatic biochemical analysis. The normal value is 50-200 pg/mL. When it is higher than the normal value, it may indicate cardiovascular stress or metabolic disorders; when it is lower than the normal value, it may be associated with endothelial dysfunction or certain chronic diseases.
Measured: Baseline
Chemerin
Serum level of Chemerin in ng/mL, which is determined by automatic biochemical analysis. The normal value is 50-150 ng/mL. When it is higher than the normal value, it may indicate obesity, insulin resistance, or inflammatory states; when it is lower than the normal value, it may be associated with metabolic dysregulation.
Measured: Baseline
Interleukin-6 (IL-6)
Serum level of Interleukin-6 (IL-6) in pg/mL, which is determined by automatic biochemical analysis. The normal value is <7 pg/mL. When it is higher than the normal value, it indicates an inflammatory response, infection, or autoimmune disease; when it is lower than the normal value, it is generally considered within the normal physiological range.
Measured: Baseline
Interleukin-10 (IL-10)
Serum level of Interleukin-10 (IL-10) in pg/mL, which is determined by automatic biochemical analysis. The normal value is <9.1 pg/mL. When it is higher than the normal value, it may indicate an anti-inflammatory response or certain chronic inflammatory conditions; when it is lower than the normal value, it may be associated with impaired immune regulation.
Measured: Baseline
Transforming Growth Factor-β (TGF-β)
Serum level of Transforming Growth Factor-β (TGF-β) in ng/mL, which is determined by automatic biochemical analysis. The normal value is 5-30 ng/mL. When it is higher than the normal value, it may indicate fibrotic processes, chronic inflammation, or certain cancers; when it is lower than the normal value, it may be associated with impaired tissue repair or immune dysregulation.
Measured: Baseline
Tumor Necrosis Factor-α (TNF-α)
Serum level of Tumor Necrosis Factor-α (TNF-α) in pg/mL, which is determined by automatic biochemical analysis. The normal value is <8.1 pg/mL. When it is higher than the normal value, it indicates systemic inflammation, infection, autoimmune diseases, or certain malignancies; when it is lower than the normal value, it is generally within the normal physiological range.
Measured: Baseline
Irisin
Serum level of Irisin in ng/mL, which is determined by automatic biochemical analysis. The normal value is 3-5 ng/mL. When it is higher than the normal value, it may indicate increased physical activity or improved metabolic status; when it is lower than the normal value, it may be associated with sedentary lifestyle, obesity, or metabolic disorders.
Measured: Baseline
Myostatin
Serum level of Myostatin in ng/mL, which is determined by automatic biochemical analysis. The normal value is 5-15 ng/mL. When it is higher than the normal value, it may indicate muscle wasting conditions or impaired muscle regeneration; when it is lower than the normal value, it may be associated with increased muscle mass or certain metabolic adaptations.
Measured: Baseline
Testosterone
Serum level of Testosterone in ng/dL, which is determined by automatic biochemical analysis. The normal range is 300-1000 ng/dL for adult males and 15-70 ng/dL for adult females. When it is higher than the normal range, it may indicate hyperandrogenism or endocrine disorders; when it is lower than the normal range, it may indicate hypogonadism or age-related decline.
Measured: Baseline
Estrogen
Serum level of Estrogen (Estradiol, E2) in pg/mL, which is determined by automatic biochemical analysis. The normal range varies by gender and life stage: for premenopausal women it is 30-400 pg/mL (varies with menstrual cycle), for postmenopausal women it is <30 pg/mL, and for adult men it is 10-50 pg/mL. When it is higher than the normal range, it may indicate estrogen dominance or certain tumors; when it is lower than the normal range, it may indicate ovarian failure, menopause, or endocrine disorders.
Measured: Baseline
Serum Creatinine
Serum level of Creatinine in μmol/L, which is determined by automatic biochemical analysis. The normal range is 44-133 μmol/L for adult males and 70-106 μmol/L for adult females. When it is higher than the normal range, it may indicate impaired renal function or muscle disorders; when it is lower than the normal range, it may be associated with decreased muscle mass or liver disease.
Measured: Baseline
Cystatin C
Serum level of Cystatin C in mg/L, which is determined by automatic biochemical analysis. The normal range is 0.55-1.02 mg/L. When it is higher than the normal range, it indicates impaired renal function; when it is lower than the normal range, it may be associated with hyperthyroidism or pregnancy.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start10 Jan 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OVCF DatabaseStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wangjing Hospital, China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Suzhou TCM Hospital Affiliated to Nanjing University of Chinese Medicine, Shandong Wendeng Orthopedic Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07321795
- Sponsor's protocol ID
- WJEC-KT-2025-047-P001
- Status last verified
- Jan 2026
- First submitted
- 22 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteoporotic Vertebral Compression Fractures: A Multi-center Cohort Study Based on Disease and Syndrome Differentiation
- ClinicalTrials.gov ID
- NCT07321795
- Acronym / sponsor ID
- WJEC-KT-2025-047-P001
- Conditions
- OVCF Database, Cohort Study
- Keywords
- Osteoporotic Vertebral Compression Fractures, Traditional Chinese Medicine, Potential biomarkers, Risk prediction model
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Wangjing Hospital, China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Suzhou TCM Hospital Affiliated to Nanjing University of Chinese Medicine, Shandong Wendeng Orthopedic Hospital
- Study start
- 10 Jan 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 Jan 2026 (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 study aims to construct an early warning model for Osteoporotic Vertebral Compression Fracture (OVCF) by integrating TCM syndrome patterns with modern risk factors. This is a multi-center cohort study on OVCF integrated with disease and syndrome differentiation in Traditional Chinese Medicine (TCM).
Detailed description
The subjects are selected according to the inclusion criteria and exclusion criteria. A total of 200 subjects will be recruited from four participating tertiary hospitals and categorized into four groups: individuals with normal bone mass, osteopenia, osteoporosis, and Osteoporotic Vertebral Compression Fracture (OVCF) . Data collection encompasses three levels:
- Macro-level: Demographics, lifestyle, medical history, and physical metrics.
- Meso-level: TCM syndrome diagnoses, bone mineral density (BMD), MRI assessments, and functional scores (VAS, ODI).
- Micro-level: Serum biomarkers related to bone metabolism, lipids, inflammation, and muscle health.
Strict quality control measures will be implemented, including researcher training and data monitoring. The integrated database and analytical framework are designed to develop a practical, population-specific risk prediction tool for OVCF.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| normal bone mass group | – | – |
| osteopenia group | – | – |
| osteoporosis group | – | – |
| Osteoporotic Vertebral Compression Fracture group | – | – |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants are selected from patients admitted to four participating tertiary hospitals
Key inclusion criteria (3 listed)
- 1.50 years ≤ age < 80 years; gender includes both male and female. 2.Meet the diagnostic criteria for new-onset osteoporotic vertebral compression fracture.
- 3.Voluntarily participate in this clinical study and sign the informed consent form.
- Subjects meeting only criteria (1) and (3) with a T-score ≥ -1.0 can be included in the normal bone mass group. Subjects meeting criteria (1) and (3) with -2.5 < T-score < -1.0 can be included in the osteopenia group. Subjects meeting criteria (1) and (3) with T-score ≤ -2.5, meeting the diagnostic criteria for osteoporosis, can be included in the OP group. Subjects meeting all criteria (1), (2), and (3) will be included in the OVCF patient group.
Key exclusion criteria (5 listed)
- Patients with serious concomitant cardiovascular/cerebrovascular diseases, liver/kidney diseases, malignant tumors, or other wasting diseases, and patients with infectious diseases.
- Patients with other endocrine system diseases, such as Cushing's syndrome, hyperthyroidism, hypothyroidism, etc.
- Patients who have participated in other clinical trials within the past 3 months.
- Patients with concomitant Alzheimer's disease, mental illnesses or depression, or those unable to cooperate to complete the trial.
- Patients with poor compliance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bone Mineral Density (BMD)
Time frame: Baseline
DXA will be used to measure lumbar spine (L1-L4) and bilateral hip density, recording the T-score for each site. Instrument precision will be set to 1% (i.e., repeated measurement error < 1%). Professionals will be responsible for post-use accuracy checks and maintenance.
31 secondary outcomes
Muscle Strength
Time frame: Baseline
The bone marrow fat fraction (FF)
Time frame: Baseline
Paravertebral muscle area
Time frame: Baseline
Fatty infiltration
Time frame: Baseline
Vertebral bone quality (VBQ) score
Time frame: Baseline
Visual Analogue Scale (VAS) Score
Time frame: Baseline
Lumbar Oswestry Disability Index (ODI) Score
Time frame: Baseline
OP TCM Syndrome Information
Time frame: Baseline
OVCF TCM Syndrome Information
Time frame: Baseline
Total Type I Procollagen N-terminal Propeptide (P1NP)、β-Cross-linked C-telopeptide of Type I Collagen (β-CTX)
Time frame: Baseline
Serum bone glaprotein (BGP)
Time frame: Baseline
25-Hydroxyvitamin D (25(OH)D)
Time frame: Baseline
Intact Parathyroid Hormone (PTH)
Time frame: Baseline
Total Cholesterol (TC)
Time frame: Baseline
Triglycerides (TG)
Time frame: Baseline
High-Density Lipoprotein Cholesterol (HDL-C)
Time frame: Baseline
Low-Density Lipoprotein Cholesterol (LDL-C)
Time frame: Baseline
Leptin
Time frame: Baseline
Visfatin
Time frame: Baseline
Apelin
Time frame: Baseline
Chemerin
Time frame: Baseline
Interleukin-6 (IL-6)
Time frame: Baseline
Interleukin-10 (IL-10)
Time frame: Baseline
Transforming Growth Factor-β (TGF-β)
Time frame: Baseline
Tumor Necrosis Factor-α (TNF-α)
Time frame: Baseline
Irisin
Time frame: Baseline
Myostatin
Time frame: Baseline
Testosterone
Time frame: Baseline
Estrogen
Time frame: Baseline
Serum Creatinine
Time frame: Baseline
Cystatin C
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: No
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of OVCF Database and Cohort Study, run by Wangjing Hospital, China Academy of Chinese Medical Sciences at 4 sites 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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xu Wei, Ph.D (+8613488716557, weixu.007@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Mineral Density (BMD) (time frame: Baseline). 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 9 Jan 2026.