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Development of a Fragility Fracture Prediction Model Based on the Theory "Growth Strength Aging and Senescence Are Determined by the Kidney" and Pharmacodynamic Study of Congrong Shenhuo Yugu Formula in Promoting Fracture Healing: A Prospective Multicenter Cohort Study on Osteoporotic Fractures

Development of a Fragility Fracture Prediction Model Based on the Theory "Growth Strength Aging and Senescence Are Determined by the Kidney" and Pharmacodynamic Study of Congrong Shenhuo Yugu Formula in Promoting Fracture Healing: A Prospective Multicenter Cohort Study on Osteoporotic Fractures

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2025000686
Enrollment
Unknown
Registered
2025-04-10
Start date
2025-03-13
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

osteoportic fracture

Interventions

Without Osteoportic fracture:None
Fracture with abnormal BMD:None

Sponsors

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1).Patients clinically diagnosed with fracture disorders (including but not limited to bilateral hips vertebral bodies forearms etc.) by orthopedic specialists according to ICD-10 diagnostic criteria; 2).Age = 18 years old; 3). Receiving standard perioperative therapeutic protocols and clinical management for fractures in hospital settings; 4).Individuals with cognitive competence to actively participate in research investigations examinations and adhere to follow-up schedules with written informed consent provided by the participant and/or legal guardian(s).

Exclusion criteria

Exclusion criteria: 1).Patients diagnosed with fractures of small joints in extremities or skull fractures by orthopedic specialists according to ICD-10 criteria; 2).Patients sustaining injuries from severe trauma (including but not limited to violent assaults suicidal falls) as documented in admission records; 3).Individuals with unstable vital signs impaired consciousness (Mini-MoCA score <12) or severe intractable pain precluding cooperation; 4).Cases of secondary osteoporosis (e.g. osteomalacia gout multiple myeloma) or severe endocrine comorbidities (including Cushings disease hypercalcemia hypercalciuria cardiorenal insufficiency); 5).Chronic concurrent users of medications affecting bone metabolism that cannot be discontinued; 6).Subjects with advanced deformities disabilities or loss of working capacity; 7).Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Recurrent fracture death (cause of death time of death);

Secondary

MeasureTime frame
Bone metabolism index;Indexes of calcium and phosphorus metabolism;Bone mineral density;Metagenomic sequencing;Physical examination index;Targeting metabolomics;visual analogue scale;Blood routine index;

Countries

China

Contacts

Public ContactYongjun Wang

Longhua hospital affiliated to Shanghai University of Traditional Chinese medicine

wangyongjun@shutcm.edu.cn+86 135 8580 2162

Outcome results

None listed

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