Phase 3
Completed N=110
Efficacy of Zoledronic Acid in Preventing Collapse of the Osteonecrotic Femoral Head
Avascular Necrosis of Femoral Head
Source: ClinicalTrials.gov NCT00939900 ↗
Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Jul 2015
Primary outcomePrimary: Number of Participants With Femoral Head Collapse Within 24 Months — 29; 22 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Femoral Head Collapse Within 24 Months |
29; 22 | — |
| SECONDARY Collpase Rate of Femoral Head |
— | — |
| SECONDARY Change of HHS (Harris Hip Scores), WOMAC Score, SF-36 |
— | — |
| SECONDARY Time to Collapse of Femoral Head |
— | — |
| SECONDARY Time to Total Arthroplasty or Joint Preserving Surgery |
— | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00939900). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.