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Study Comparing Ibandronate Versus Placebo in Hip Osteonecrosis

NCT02114489 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2017-05-17

No results posted yet for this study

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.

Conditions

  • Aseptic Hip Necrosis
  • Hip Necrosis

Interventions

DRUG

ibandronate

Unique perfusion of ibandronate 3 mg IV

DRUG

Placebo

Sponsors & Collaborators

  • Brigitte Jolles, MD

    lead OTHER

Principal Investigators

  • Bérengère Aubry-Rpzier, Dr · University of Lausanne Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2017-03-31
Completion
2017-03-31

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02114489 on ClinicalTrials.gov