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A comparative study on the consistency and clinical diagnostic efficacy of bone metabolism marker detection systems based on different sample types

A comparative study on the consistency and clinical diagnostic efficacy of bone metabolism marker detection systems based on different sample types

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600117637
Enrollment
Unknown
Registered
2026-01-27
Start date
2026-01-31
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Osteoporosis

Interventions

Healthy Control Group:None

Sponsors

The Ethics Committee of the First Affiliated Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Osteoporosis Group 1. Age >= 18 years, either sex; 2. Osteoporosis group: Diagnosed with osteoporosis according to DXA bone mineral density criteria (T-score -1.0); 3. No history of fracture and no history of metabolic bone disease; 4. Voluntarily participates in the study and signs the informed consent form.

Exclusion criteria

Exclusion criteria: Osteoporosis Group 1. Suffering from severe liver or kidney dysfunction; 2. Suffering from other diseases affecting bone metabolism, such as hyperparathyroidism, malignant bone metastasis, or multiple myeloma; 3. Received drug treatment affecting bone metabolism within the past 3 months. Healthy Control Group 1. Suffering from severe liver or kidney dysfunction; 2. Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Bone Metabolism Markers;Peripheral blood was used to determine ß-CTX, TPINP and 25-OH VD;The area under the curve (AUC) of each marker under the three sample types (serum, peripheral blood, and dried blood smear) and the sensitivity and specificity at their respective optimal cut-off values;

Countries

China

Contacts

Public ContactYang Huiling

The First Affiliated Hospital of Soochow University

zuhaiyue@suda.edu.cn+86 134 0502 5198

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026