The effect of bisphosphonates and bone density on aseptic joint loosening of the hip

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IPR-15006922

Enrollment

Unknown

Registered

2015-08-01

Start date

2014-12-02

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

aseptic joint loosening of the hip

Interventions

1:alendronate

2:zoledronate

Eligibility

Sex/Gender

All

Age

40 Years to 70 Years

Inclusion criteria

Inclusion criteria: Part 1 1. Aged from 40-70; 2. Type A or B of Dorr classification; 3. Prepare to undergo total hip arthroplasty(cementless) because of femoral head fracture or femoral head necrosis; 4. Tolerance operation; 5. Patient and his/her family members agree to accept the operation; 6. Informed consent has been signed. Part 2 1. Aged from 40-70; 2. Type A or B of Dorr classification; 3. Prepare to undergo total hip arthroplasty(cementless) because of femoral head fracture or femoral head necrosis; 4. T<-2.5(measured by DXA, or has the history of fragility fracture; 5. Tolerance operation; 6. Patient and his/her family members agree to accept the operation; 7. Informed consent has been signed.

Exclusion criteria

Exclusion criteria: Part 1 1. MNA-SF<11, indicating malnutrition; 2. Dianosised with disease can cause secondary osteoporosis; 3. Dianosised with severe medical disease or tumor; 4. Dianosised with malposition of prosthesis or periprosthesis infection; 5. T<-2.5 (measured by DXA), or has the history of fragility fracture; 6. Lack of medication compliance; 7. Fail to insist on follow-up. Part 2 1. MNA-SF<11, indicating malnutrition; 2. Dianosised with disease can cause secondary osteoporosis; 3. Dianosised with severe medical disease or tumor; 4. Dianosised with malposition of prosthesis or periprosthesis infection; 5. Has the contraindication of bisphosphonate; 6. Underwent the treatment of bisphosphonate within 6 months before the operation; 7. Lack of medication compliance; 8. Fail to insist on follow-up.

Design outcomes

Primary

Measure	Time frame
Bone density of Gruen 1 zone and Gruen 7 zone around prosthesis;The incidence of aseptic loosening of artificial joints;	—

Secondary

Measure	Time frame
Whether prosthesis position in the safety zone;With or without bright line around prosthesis,prosthesis handle with or without sinking/acetabular cup with or without presence of tilt or rotate;Harris hip scores;Bone turnover index (beta-CTX and PINP) and the concentration of blood calcium, VitD;Patients with drug adverse reaction;Surgical complications;Quality of life score (EQ-5D);	—

Countries

China

Contacts

Public ContactYue Ding

dingyue36@126.com+86 13570133707

Outcome results

None listed

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