Study Comparing Ibandronate Versus Placebo in Hip Osteonecrosis

• Status: Terminated
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Aseptic osteonecrosis of the hip (AOH) concern 1 Swiss young adult to 1000 (30-40 years old). They are responsible to a severe joint destruction and in the majority of cases a joint replacement. To the hip, we can distinguish 4 stages of osteonecrosis according to Ficat: 1, 2, 3, 4. Stage 3 and 4 AOH management are unanimous surgical. But management of stage 1 and 2 are unclear. Bisphophonates are mainly used for bone and osteoporosis diseases. They decrease the bone turn over, and the risk of fracture. They also decrease the bone marrow oedema and the pain associated to this oedema. Ibandronate is a bisphosphonate with a rapid effect, a short half-life, easy to manage, and with few side effects. We designed a double-blind prospective randomized trial aiming to evaluate the efficacy of an infusion of ibandronate versus placebo on pain and AOH progression in patients with stage 1 and 2 AOH. Our hypothesis is that there will be a pain reduction >=20 mm on the VAS scale (SD 10mm) in the ibandronate group versus placebo, and a non radiological progression in the treated group.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigitte Jolles, MD
• Treatments: Diphosphonates; Ibandronic Acid

Criteria

Inclusion Criteria:

• Signed consent form

• Male and female between 18 - 50 years old

• AOH stage 1 or 2 according to Ficat

• Pain VAS scale >40 mm (0-100)

Exclusion Criteria:

• Specific aetiology of AOH already known

• Cardiac and lung uncontrolled diseases

• Active malignancy untreated

• Hyper sensibility or allergy already known to ibandronate

• Pregnancy or breast feeding

• Severe kidney insufficiency (cl<30 ml/min)

• Contra-Indications to an MRI (Pacemaker, cochlear implant...)