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A Prospective Cohort Study for Prevention & Treatment for Osteonecrosis of Femoral Head

A Prospective Cohort Study for Relationship of Glucocorticoids Exposure and Osteonecrosis of the Femoral Head

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OOC-16009127
Enrollment
Unknown
Registered
2016-08-30
Start date
2016-02-02
Completion date
Unknown
Last updated
2020-05-11

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

Conditions

Osteonecrosis of the femoral head, Rheumatological diseases

Interventions

Low-medium dose of glucocorticoids Group:The average dose of glucocorticoids is less than 40 mg/d in the first 3 months
High dose of glucocorticoids Group:The average dose of glucocorticoids is not less than 40 mg/d in the first 3 months

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Meets the diagnostic classification criteria of rheumatological diseases; 2. Aged 14 - 75 years old; 3. New cases who require sustained glucocorticoids therapy,or those who were available with the full detailed dosages of glucocorticoids and other concomitant medications history; 4. Expected peak daily dose of glucocorticoids is above 20 mg or stable medication with long term,and the expected medication longer than six months or the total dosages are above 1500 mg; 5. Cases to be informed consent and who signed the informed consent approved by the Ethic Committee.

Exclusion criteria

Exclusion criteria: 1. With history of hip fractured or traumatic brain surgery; 2. Cases have been ostoenecrosis of the femoral head before taking glucocorticoids or have been hip replacement surgery; 3. Liver or kidney function is severely impaired (either of index of AST /ALT/ Ccr / BUN is two times higher than the upper limit of normal persons,respectively ),or cases with systemic failure. 4. Combined with rheumatoid arthritis, ankylosing spondylitis or hip arthritis; 5. Suffering from any malignant tumors; 6. Cases Combined with mental disorders, dementia who can not be normal communication and answered questions; 7. Cases are physically disabled with impaired mobility,or no fixed address; 8. Cases have been long-term glucocorticoids therapy and the amount of usage/dosages are not clearly identified; 9. Unwilling or unable to fit data collection; 10. Be not suitable for MRI checking(claustrophobic, with cardiac pacemakers, metal IUDs, etc.); 11. Pregnant or Lactating women and others who do not fit.

Design outcomes

Primary

MeasureTime frame
Observe the difference between glucocorticoids doses and the incidence of femoral head necrosis;

Secondary

MeasureTime frame
Determinate whether or not there is a dose-response relationship between cocorticoid dosages and incidence of the ONFH;Identification and validation of the genetic susceptibility associated with cocorticoid-induced ONFH;

Countries

China

Contacts

Public ContactChangqing Zhang

Shanghai Sixth People's Hospital

zhangcq@sjtu.edu.cn+86 021-24058009

Outcome results

None listed

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