Back to resultsEfficacy of Zoledronic Acid in Preventing Collapse of the Osteonecrotic Femoral Head (EZAPCOFH)
Primary Purpose
Avascular Necrosis of Femoral Head
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
zoledronic acid (aclasta)
Sponsored by
About this trial
This is an interventional treatment trial for Avascular Necrosis of Femoral Head focused on measuring avascular necrosis of femoral head, bisphosphonate, collapse
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
Sites / Locations
- Seoul national University Bundang Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
aclasta
control
Arm Description
aclasta group
control group
Outcomes
Primary Outcome Measures
Number of Participants With Femoral Head Collapse Within 24 Months
Secondary Outcome Measures
Collpase Rate of Femoral Head
Change of HHS (Harris Hip Scores), WOMAC Score, SF-36
Time to Collapse of Femoral Head
Time to Total Arthroplasty or Joint Preserving Surgery
Full Information
NCT ID
NCT00939900
First Posted
July 14, 2009
Last Updated
June 7, 2015
Sponsor
Seoul National University Bundang Hospital
Collaborators
Novartis Korea Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00939900
Brief Title
Efficacy of Zoledronic Acid in Preventing Collapse of the Osteonecrotic Femoral Head
Acronym
EZAPCOFH
Official Title
Multicenter, Open-labeled, Randomized Clinical Trial to Determine the Efficacy of Zoledronic Acid in Preventing Collapse of the Osteonecrotic Femoral Head
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
Collaborators
Novartis Korea Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 with large (> 30%: criteria according to Kim et al) nontraumatic osteonecrosis.
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 operation time (3-6hours), and morbidity associated with surgery is not low. In early stage osteonecrosis, osteoclasts are activated and resorb the necrotic portion of bone and osteoblasts are followed to lay down new bone. This process can weaken the bone function to support loading and can lead to collapse of bone. Bisphophonate can inhibit this osteoclastic bone resorption and enhance osteoblastic new bone formation. Recently, everyday oral intake of alendronate with vitamin D and calcium had a high success rate to prevent the collapse and decrease of hip joint pain in a short-term follow-up. However, the compliance or adherence to everyday oral intake is questionable. Moreover, the exact comparison based on MRI according to various classifications is not available currently. There is no report about the effect of zoledronic acid to prevent early collapse and progression of joint dome depression (≥2 mm by X-ray) of the early stage large nontraumatic osteonecrosis of the femoral head or its effect on MRI signal change after infusion of zoledronic acid in noncollapsed cases (estimated about 30% of cases) The investigators need a controlled randomized multicenter interventional study about the efficacy of bisphophonates in the treatment of ONFH.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Avascular Necrosis of Femoral Head
Keywords
avascular necrosis of femoral head, bisphosphonate, collapse
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
aclasta
Arm Type
Experimental
Arm Description
aclasta group
Arm Title
control
Arm Type
No Intervention
Arm Description
control group
Intervention Type
Drug
Intervention Name(s)
zoledronic acid (aclasta)
Other Intervention Name(s)
aclasta
Intervention Description
Once-yearly administration of 5mg zoledronic acid intravenously (dosage of treatment of osteoporosis) (+ calcium:1,200mg/day, VitD:800IU/day) during study period
Primary Outcome Measure Information:
Title
Number of Participants With Femoral Head Collapse Within 24 Months
Time Frame
Measurements were done at 6, 12, 24 months
Secondary Outcome Measure Information:
Title
Collpase Rate of Femoral Head
Time Frame
Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m)
Title
Change of HHS (Harris Hip Scores), WOMAC Score, SF-36
Time Frame
Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m)
Title
Time to Collapse of Femoral Head
Time Frame
Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m)
Title
Time to Total Arthroplasty or Joint Preserving Surgery
Time Frame
Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyung-Hoi Koo, professor
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul national University Bundang Hospital
City
Seongnam-Si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Zoledronic Acid in Preventing Collapse of the Osteonecrotic Femoral Head
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