Status:
UNKNOWN
Osteonecrosis of the Hip and Bisphosphonate Treatment
Lead Sponsor:
University of Sydney
Collaborating Sponsors:
Novartis
Conditions:
Osteonecrosis
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
Osteonecrosis of the hip is an important cause of musculoskeletal disability and finding therapeutic solutions has proven to be challenging. Osteonecrosis means death of bone which can occur from the ...
Detailed Description
Osteonecrosis (ON) of the hip is an important cause of musculoskeletal disability and finding therapeutic solutions has proven challenging. Patients who are affected with ON are often relatively young...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00781261
Start Date
August 1 2009
End Date
December 1 2013
Last Update
January 14 2013
Active Locations (5)
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1
Royal North Shore Hospital, Department of Rheumatology
Sydney, New South Wales, Australia, 2065
2
Princess Alexandra Hospital
Brisbane, Queensland, Australia, 4102
3
Royal Brisbane and Womens Hospital
Herston, Queensland, Australia, 4029
4
The Queen Elizabeth Hospital
Adelaide, South Australia, Australia, 5011