Last updated on January 2013

Osteonecrosis of the Hip and Bisphosphonate Treatment


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Osteonecrosis
  • Age: Between 18 - 90 Years
  • Gender: Male or Female
  • Other:
    aged between 18-90 years,
    symptoms of pain and disability in at least one hip joint, or
    positive MRI findings stage I or II on the ARCO classification

You may not be eligible for this study if the following are true:

  • previous hip joint surgery on the affected hip
    severe pain and disability at rest if treating clinician has recommended surgery
    radiographic or MRI findings suggestive for stage III and IV on the ARCO
    classification
    any iv bisphosphonate within the prior 2 years or any prior use of bisphosphonate
    preparations, except according to the washout schedule:
    2 years (if use > 48 weeks),
    1 year (if used > 8 weeks but < 48 weeks)
    6 months (if used > 2 weeks but < 8 weeks)
    2 months (if used < 2 weeks)
    active primary hyperparathyroidism
    hypothyroidism, not appropriately controlled with long-term thyroxine therapy
    history of iritis or uveitis, except due to trauma, and resolved for > 2 years prior
    to study
    self-reported history of diabetic nephropathy or retinopathy (if diabetic, Hb A1c >
    10%)
    urine dipstick greater than or equal to 2+ protein at screening
    AST or ALT greater than twice the upper limit of normal and/or alkaline phosphatase
    greater than twice the upper limit of normal
    serum calcium > 2.75 mmol/L (11.0 mg/dL) or < 2.00 mmol/L (8.0 mg/dL)
    serum 25-hydroxyvitamin D concentrations < 15 ng/L m) baseline renal insufficiency
    (calculated creatinine clearance less than 40 mL/min and serum creatinine greater
    than 175 mol/L) at V1
    a history of invasive malignancy of any organ system, treated or untreated, in the
    past five years; excluding, basal cell or squamous cell carcinoma of the skin,
    colonic polyps with non-invasive malignancy which have been removed, ductal carcinoma
    in-situ (DCIS), and carcinoma in-situ (CIS) of the uterine cervix
    any candidate patient with severe dental problems or current dental infections and/or
    any candidate patient with recent or impending dental surgery within three months of
    dosing
    women of childbearing potential not using the contraception method(s) specified in
    this study (specify), as well as women who are breastfeeding

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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