Efficacy of Zoledronic Acid in Preventing Collapse of the Osteonecrotic Femoral Head

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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 with large (> 30%: criteria according to Kim et al) nontraumatic osteonecrosis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Bundang Hospital
• Collaborator: Novartis Korea Ltd.
• Treatments: Diphosphonates; Zoledronic Acid

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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