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| Name | Class |
|---|---|
| Novartis Korea Ltd. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aclasta | Experimental | aclasta group |
|
| control | No Intervention | control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zoledronic acid (aclasta) | Drug | Once-yearly administration of 5mg zoledronic acid intravenously (dosage of treatment of osteoporosis) (+ calcium:1,200mg/day, VitD:800IU/day) during study period |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Femoral Head Collapse Within 24 Months | Measurements were done at 6, 12, 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Collpase Rate of Femoral Head | Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m) | |
| Change of HHS (Harris Hip Scores), WOMAC Score, SF-36 | Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyung-Hoi Koo, professor | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul national University Bundang Hospital | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aclasta | aclasta group zoledronic acid (aclasta): Once-yearly administration of 5mg zoledronic acid intravenously (dosage of treatment of osteoporosis) (+ calcium:1,200mg/day, VitD:800IU/day) during study period |
| FG001 | Control | control group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aclasta | aclasta group zoledronic acid (aclasta): Once-yearly administration of 5mg zoledronic acid intravenously (dosage of treatment of osteoporosis) (+ calcium:1,200mg/day, VitD:800IU/day) during study period |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Femoral Head Collapse Within 24 Months | Posted | Number | participants | Measurements were done at 6, 12, 24 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aclasta | aclasta group zoledronic acid (aclasta): Once-yearly administration of 5mg zoledronic acid intravenously (dosage of treatment of osteoporosis) (+ calcium:1,200mg/day, VitD:800IU/day) during study period |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor | SeoulNUBH | 82317877194 | khkoo@snu.ac.kr |
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| ID | Term |
|---|---|
| D005271 | Femur Head Necrosis |
| D014474 | Unconsciousness |
| ID | Term |
|---|---|
| D010020 | Osteonecrosis |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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|
| Time to Collapse of Femoral Head | Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m) |
| Time to Total Arthroplasty or Joint Preserving Surgery | Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m) |
control group
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Collpase Rate of Femoral Head | Not Posted | Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m) |
| Secondary | Change of HHS (Harris Hip Scores), WOMAC Score, SF-36 | Not Posted | Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m) |
| Secondary | Time to Collapse of Femoral Head | Not Posted | Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m) |
| Secondary | Time to Total Arthroplasty or Joint Preserving Surgery | Not Posted | Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m) |
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | Control | control group | 0 | 55 | 0 | 55 |
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D007093 |
| Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |