Study Comparing Ibandronate Versus Placebo in Hip Osteonecrosis
Status:
Terminated
Trial end date:
2017-03-01
Target enrollment:
Participant gender:
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.