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

NCT00939900 | Completed Phase 3 Results DMC

• 1 other identifier: CZOL446HKR08T
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Avascular Necrosis of Femoral Head

Keywords

avascular necrosis of femoral head; bisphosphonate; collapse

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Femoral Head Collapse Within 24 Months

  Measurements were done at 6, 12, 24 months

Secondary Outcomes (4)

• 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)

• 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)

Study Arms (2)

aclasta

EXPERIMENTAL

aclasta group

Drug: zoledronic acid (aclasta)

control

NO INTERVENTION

control group

Interventions

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

Also known as: aclasta

aclasta

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead
• Novartis Korea Ltd.: collaborator

Study Sites (1)

Seoul national University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Femur Head Necrosis; Unconsciousness

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Osteonecrosis; Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Professor
• Organization: SeoulNUBH

khkoo@snu.ac.kr

82317877194

Study Officials

• Kyung-Hoi Koo, professor

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 14, 2009
• First Posted: July 15, 2009
• Study Start: July 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: July 2, 2015
• Results First Posted: July 2, 2015

Record last verified: 2015-06

Locations

KR (1)