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The study of identification and mechanism of new biomarkers to early predict the efficacy and adverse reactions of zoledronic acid in anti-osteoporosis treatment by using metabolomics

The study of identification and mechanism of new biomarkers to early predict the efficacy and adverse reactions of zoledronic acid in anti-osteoporosis treatment by using metabolomics

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100042652
Enrollment
Unknown
Registered
2021-01-24
Start date
2021-02-01
Completion date
Unknown
Last updated
2021-05-10

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

Conditions

postmenopausal osteoporosis

Interventions

PMOP:no intervention
Volunteer:no intervention

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Fully understand the pros and cons of various anti-osteoporosis drugs, voluntarily choose zoledronic acid treatment, are willing to supplement calcium and vitamin D, and voluntarily participate in this study 2. Shanghai women of Han nationality aged 50-80 with natural menopause for at least 1 year. 3. There are no severe lumbar anatomical abnormalities that affect DXA bone mineral density measurement, such as severe scoliosis. 4. Meet the diagnostic criteria of osteoporosis in the "Guidelines for the Diagnosis and Treatment of Primary Osteoporosis (2017)" (meet any 1 item): (1) The bone density of the lumbar vertebrae 1-4 or the neck of the femur or the total hip is lower than that of the youth The 2.5SD of women peak bone density is the standard for osteoporosis; (2) There is a fragility fracture, after 50 years of age, of the hip or vertebral body caused by minor trauma (injury strength equals fall from standing height); (3) Lumbar vertebra 1- 4 Or femoral neck or total hip bone density is between -1 to -2.5 peak bone mineral density in young women, and there are fragility fractures of the proximal humerus or pelvis or distal forearm. 5. Understand the process of this study, have good compliance, and are willing to follow up regularly.

Exclusion criteria

Exclusion criteria: 1. Severe cardiovascular diseases: such as myocardial infarction, unstable angina, severe arrhythmia, etc; 2. Chronic liver disease, abnormal liver function (ALT > 1.5 times the upper limit of normal); renal insufficiency (creatinine clearance rate 7.0mmol/L), etc.; 8. Bone mineral diseases: such as hypoparathyroidism or hyperthyroidism, deformed osteitis, osteogenesis imperfecta, osteomalacia, etc; 9. Blood system disorders: such as leukopenia ( 3 months (including any type of bisphosphonate drugs, estrogen receptor modulators, estrogen, active vitamin D, etc.); 15. Previous use of intramuscular injection or nasal spray of calcitonin for > 3 months; 16. Any type of intravenous bisphosphonate administration in the past; 17. Those who have used parathyroid hormone in the past; 18. Previously used drugs that may be related to bone metabolism, including traditional Chinese medicine.

Design outcomes

Primary

MeasureTime frame
bone mineral density;Small molecule metabolites;

Secondary

MeasureTime frame
bone turnover markers;

Countries

China

Contacts

Public ContactChun Wang

Shanghai Sixth People's Hospital

15301690670@163.com+86 15301690670

Outcome results

None listed

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