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Clinical study on biomarkers of kidney deficiency syndrome in postmenopausal osteoporosis

Clinical study on biomarkers of kidney deficiency syndrome in postmenopausal osteoporosis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300076600
Enrollment
Unknown
Registered
2023-10-12
Start date
2023-10-31
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

postmenopausal osteoporosis

Interventions

Group of postmenopausal osteoporosis :None

Sponsors

Wangjing Hospital of China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
45 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Postmenopausal women, 45 years old = age < 65 years old; Menopause more than 1 year. (2) The diagnostic criteria for PMOP are met. The diagnostic criteria for PMOP based on the bone density of the axial bone (lumbar 1-4, femoral neck or total hip) or the bone density of the distal 1/3 of the radius measured by DXA are T-value =-2.5. (3) It meets the standard of TCM syndrome differentiation of kidney-yang deficiency or liver-kidney Yin deficiency syndrome. (4) Voluntarily participate in this clinical study and sign the informed consent. If only conditions (1) and (4) are met at the same time, and the T-value is =-1.0, you can be included in the healthy subjects. At the same time, patients who meet the conditions (1), (2), (3) and (4) are included in the ranks of PMOP patients.

Exclusion criteria

Exclusion criteria: (1) Patients with previous osteoporotic fractures. (2) Patients with secondary osteoporosis; Including metabolic diseases secondary to diabetes, thyroid disease, Cushing syndrome, etc. Chronic nephritis, malabsorption syndrome, chronic hepatitis and other systemic diseases. (3) Patients with serious organic and functional diseases such as malignant tumors, cardiovascular, cerebrovascular, liver, kidney and hematopoietic systems. (4) Patients who took drugs affecting bone metabolism within 3 months, such as bisphosphonates, glucocorticoids, calcitonin, anticonvulsants, heparin and other drugs. (5) Participants in other clinical trials within 3 months.

Design outcomes

Primary

MeasureTime frame
ADCYAP1;CDH1;MUC1;

Secondary

MeasureTime frame
P1NP;ß-CTX;E2;BGP;ALP;BALP;TRACP;OPG;25(OH)D;PTH;

Countries

China

Contacts

Public ContactWei Xu

Wangjing Hospital, China Academy of Chinese Medical Sciences

weixu.007@163.com+86 134 8871 6557

Outcome results

None listed

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