Study Comparing Ibandronate Versus Placebo in Hip Osteonecrosis

NCT02114489 | Terminated Phase 3 DMC

• 1 other identifier: SwissMedic 136/13
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

AOH; ibandronate

Outcome Measures

Primary Outcomes (2)

• VAS pain

  Pain using a visual analogue scale

  up to 6th months after the intervention

• Imagery assessment

  MRI protocol consisting of a coronal T1-weighted, a coronal fat-suppressed (FS) T2-weighted, axial and sagittal FS proton density (PD)-weighted sequences and a sagittal PD-weighted sequence, all without intravenous administration of Gadolinium-based contrast medium. All these sequences will have a small field-of-view (FOV) in order to improve spatial resolution.

  up to 6th months after the intervention

Secondary Outcomes (4)

• The Western Ontario and McMaster Universities Arthritis Index (Womac scale)

  up to 6 months

• Gait Analysis

  up to 6 months

• Hip Harris score

  up to 6 months

• Health-related quality of life EQ5D questionnaire

  up to 6 months

Study Arms (2)

Ibandronate

EXPERIMENTAL

Unique perfusion of ibandronate 3 mg IV

Drug: ibandronate

Placebo

PLACEBO COMPARATOR

Unique perfusion of NaCl 3mg IV

Drug: Placebo

Interventions

ibandronate DRUG

Unique perfusion of ibandronate 3 mg IV

Also known as: Bonviva

Ibandronate

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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...)

Sponsors & Collaborators

• Brigitte Jolles, MD: lead

Study Sites (1)

Lausanne University Hospital

Lausanne, Canton of Vaud, 1005, Switzerland

Location

MeSH Terms

Interventions

Ibandronic Acid

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Officials

• Bérengère Aubry-Rpzier, Dr

  University of Lausanne Hospitals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 11, 2014
• First Posted: April 15, 2014
• Study Start: June 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: May 17, 2017

Record last verified: 2017-05

Locations

CH (1)