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Mechanism Study of ZiShen JianGu Formula Mediating the Treatment of Primary Osteoporosis via the TGF-ß1/COX-2/PGE2 Axis-Regulated Intraosseous Sensation

Mechanism Study of ZiShen JianGu Formula Mediating the Treatment of Primary Osteoporosis via the TGF-ß1/COX-2/PGE2 Axis-Regulated Intraosseous Sensation

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2025002144
Enrollment
Unknown
Registered
2025-11-08
Start date
2025-11-10
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Osteoporosis

Interventions

primary osteoporosis group:none
control group:none

Sponsors

Shenzhen Hospital of Integrated Traditional Chinese and Western Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 80 Years

Inclusion criteria

Inclusion criteria: Age Requirement??: =45 years old.??Diagnostic Criteria (based on Dual-Energy X-ray Absorptiometry DXA)??:??OP Group??: Lumbar spine bone mineral density (BMD) T-score = -2.5 (meeting diagnostic criteria for osteoporosis).??Normal Group??: Lumbar spine bone mineral density (BMD) T-score > -1.0 (indicating normal bone density).??Health Status??: Absence of severe cardiac hepatic or renal dysfunction.??Medication and Medical History??: No other diseases affecting bone metabolism (e.g. thyroid disorders diabetes); No recent use of bone metabolism-related medications (e.g. bisphosphonates).

Exclusion criteria

Exclusion criteria: 1)Patients with diseases involving the heart lungs liver kidneys or thyroid ??including?? those with diabetes mellitus rheumatic and connective tissue diseases gynecological diseases digestive system disorders osteitis fibrosa osteomalacia or severe cardiovascular and cerebrovascular diseases;2)Patients who have taken medications affecting bone metabolism (e.g. sex hormones glucocorticoids) within the preceding six months;3)Individuals with substance abuse issues such as alcoholism;4)Cases presenting during the acute phase of fractures.

Design outcomes

Primary

MeasureTime frame
Core pathway indicators (TGF-ß1,COX-2 and PGE2concentration, EP4 activity levels);Osteogenic functional markers (Serum calcium, Phosphorus, ALP, Osterix, RUNX2)?;Bone quality indicators (Bone mineral density (BMD));

Secondary

MeasureTime frame
Patient baseline data (Age, Sex/Gender, Body Mass Index (BMI), History of Present Illness (HPI), Past Medical History (PMH), Surgical History, Medication History, Blood Pressure (BP), Serum Albumin (ALB), Serum Creatinine (SCr), Blood Lipids, Serum Uric Acid (SUA), Fasting Blood Glucose (FBG), and other general biochemical parameters);Pattern/syndrome of TCM differentiation (Kidney essence deficiency pattern: soreness and weakness of the waist and knees, aversion to cold and cold limbs, dizziness and tinnitus; Liver-kidney yin deficiency pattern: blurred vision, five-center heat/fever, red tongue with scant coating);

Countries

China

Contacts

Public ContactLin Xiaosheng

Shenzhen Hospital of Integrated Traditional Chinese and Western Medicine?

lxshengtcm@126.com13902908795

Outcome results

None listed

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