Status:
COMPLETED
Efficacy of Zoledronic Acid in Preventing Collapse of the Osteonecrotic Femoral Head
Lead Sponsor:
Seoul National University Bundang Hospital
Collaborating Sponsors:
Novartis Korea Ltd.
Conditions:
Avascular Necrosis of Femoral Head
Eligibility:
All Genders
19-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to test the effect of zoledronic acid over 2 years in preventing early collapse and progression of joint dome depression (≥ 2 mm by X-ray) of the femoral head in patients ...
Detailed Description
Until now, the best treatment option in early (precollapse) large osteonecrosis femoral head is vascularizing fibular graft. However, it requires high microsurgical technique. Also it needs very long ...
Eligibility Criteria
Inclusion
- Patient who agree to clinical trial
- Patient who are more than 18 years of age
- Osteonecrosis of the femoral head
- Steinberg stage I, II non traumatic osteonecrosis of femoral head
- Necrotic area of \> 30% (HJ Kim et al )
- JIC (Japanese Investigation Committee): C1 or C2 lateral lesion (by X-ray or MRI)
Exclusion
- Patients who are pregnant (patients who are of child bearing potential who are not practicing a reliable contraceptive method (oral, subcutaneous, mechanical, or surgical contraception)
- Patients who have contraindicated condition to zoledronic acid such as chronic renal failure (calculated creatinine clearance less than 35.0 ml/min), severe heart disease such as atrial fibrillation, sensitive to bisphosphonates and hypocalcemia (serum calcium less than 8 mg/dl or 2.0 mmol/L)
- Patients who have collapsed lesion including subchonral fracture
- Patients who have multiple lesion of osteonecrosis of femoral head
- Patients who received other kinds of bisphophonates or anabolic agents before zoledronic acid use
- Patients with any medical or psychiatric condition which, in the Investigator's opinion would preclude the participant from adhering to the Protocol or completing the trial per protocol
- Patients who are considered potentially unreliable and patients who may not reliably attend study visits
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00939900
Start Date
July 1 2009
End Date
June 1 2012
Last Update
July 2 2015
Active Locations (1)
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1
Seoul national University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 463-707