Avascular Necrosis of Femoral HeadPhase 3EZAPCOFHNCT00939900
Efficacy of Zoledronic Acid in Preventing Collapse of the Osteonecrotic Femoral Head
A Phase 3 study testing zoledronic acid (aclasta) in people with Avascular Necrosis of Femoral Head, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Avascular Necrosis of Femoral Head
- What is being tested?
- zoledronic acid (aclasta)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2009to Jun 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul national University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: Multicenter, Open-labeled, Randomized Clinical Trial to Determine the Efficacy of Zoledronic Acid in Preventing Collapse of the Osteonecrotic Femoral Head
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.
Read the 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.
- Conditions
- Avascular Necrosis of Femoral Head
- Being tested
- zoledronic acid (aclasta)
- Keywords
- avascular necrosis of femoral head, bisphosphonate, collapse
- Medical subject headings
- Femur Head Necrosis, Unconsciousness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zoledronic acid (aclasta)Drug
Also called aclasta
Once-yearly administration of 5mg zoledronic acid intravenously (dosage of treatment of osteoporosis) (+ calcium:1,200mg/day, VitD:800IU/day) during study period
| Study group | Role | What they receive |
|---|---|---|
| aclasta | Experimental | aclasta group Receives: Drug: zoledronic acid (aclasta) |
| control | No intervention | control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Femoral Head Collapse Within 24 Months
Measured: Measurements were done at 6, 12, 24 months
Secondary outcomes (4)
Collpase Rate of Femoral Head
Measured: Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m)
Change of HHS (Harris Hip Scores), WOMAC Score, SF-36
Measured: Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m)
Time to Collapse of Femoral Head
Measured: Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m)
Time to Total Arthroplasty or Joint Preserving Surgery
Measured: Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Avascular Necrosis of Femoral HeadStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Korea Ltd.
- Responsible party
- Principal investigator, Kyung-Hoi Koo, Seoul National University Bundang Hospital
- Investigators
- Kyung-Hoi Koo, professor, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00939900
- Sponsor's protocol ID
- CZOL446HKR08T
- Acronym
- EZAPCOFH
- Status last verified
- Jun 2015
- First submitted
- 14 Jul 2009
- Last updated
- 2 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open-labeled, Randomized Clinical Trial to Determine the Efficacy of Zoledronic Acid in Preventing Collapse of the Osteonecrotic Femoral Head
- ClinicalTrials.gov ID
- NCT00939900
- Acronym / sponsor ID
- EZAPCOFH / CZOL446HKR08T
- Conditions
- Avascular Necrosis of Femoral Head
- Keywords
- avascular necrosis of femoral head, bisphosphonate, collapse
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- Novartis Korea Ltd.
- Study start
- Jul 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 15 Jul 2009 (estimated)
- Results
- Posted 2 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aclasta | Experimental | Drug: zoledronic acid (aclasta)aclasta group |
| control | No intervention | –control group |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 )
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zoledronic acid (aclasta)Also: aclastaOnce-yearly administration of 5mg zoledronic acid intravenously (dosage of treatment of osteoporosis) (+ calcium:1,200mg/day, VitD:800IU/day) during study period | Drug | aclasta |
Primary outcome
Number of Participants With Femoral Head Collapse Within 24 Months
Time frame: Measurements were done at 6, 12, 24 months
4 secondary outcomes
Collpase Rate of Femoral Head
Time frame: Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m)
Change of HHS (Harris Hip Scores), WOMAC Score, SF-36
Time frame: Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m)
Time to Collapse of Femoral Head
Time frame: Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m)
Time to Total Arthroplasty or Joint Preserving Surgery
Time frame: Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyung-Hoi Koo, professor principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing zoledronic acid (aclasta) in people with Avascular Necrosis of Femoral Head, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Femoral Head Collapse Within 24 Months (time frame: Measurements were done at 6, 12, 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2015.