Osteonecrosis Clinical Trial
— BONESOfficial title:
A Randomised Controlled Trial of Bisphosphonate Therapy in Osteonecrosis of the Hip
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 loss of the blood supply or some other means. Although any age group may
develop osteonecrosis, most patients are between 20 and 50 years old. The most common risk
factor is a history of high steroid treatment for some medical condition. The next most
common associated condition is a history of high alcohol use. There are some cases of
osteonecrosis that occur in patients that are otherwise completely healthy with no
detectable risk factors.
In the earliest stage of the disease, x-rays appear normal and the diagnosis is made using
MRI. The advanced stages of osteonecrosis begin when the dead bone starts to fail
mechanically through a process of microfractures of the bone. As the disease progresses, the
surface begins to collapse until, finally the integrity of the joint is destroyed. A wide
range of surgical treatments with variable success rates have been proposed for the
treatment of the osteonecrosis to preserve joint integrity, including core decompression,
whereby the venous hypertension that ensues is lessened and revascularisation may be induced
leading to bone repair. Nonsurgical treatment options are limited and usually result in a
poor prognosis. Early stage disease can be treated with protected weight bearing and
physiotherapy, however some studies have shown protected weight bearing to be associated
with a greater than 85% rate of femoral head collapse. Unfortunately most studies indicate
that the risk for disease progression is greater with nonsurgical treatment than with
surgical intervention. There are no established pharmaceuticals for the prevention of
treatment of osteonecrosis. Evidence is increasing that the nitrogen containing
bisphosphonates may be beneficial in the treatment of osteonecrosis. One bisphosphonates
(alendronate) has been evaluated in 60 patients diagnosed with osteonecrosis of the hip.
Recent clinical studies have shown very promising results. All patients had symptomatic
improvement after one year. Although the follow up time ranged from 3 months to 5 years,
only 6 patients progressed to the point of needing surgery.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: 1. aged between 18-90 years, 2. symptoms of pain and disability in at least one hip joint, or 3. positive MRI findings stage I or II on the ARCO classification Exclusion Criteria: 1. previous hip joint surgery on the affected hip 2. severe pain and disability at rest if treating clinician has recommended surgery 3. radiographic or MRI findings suggestive for stage III and IV on the ARCO classification 4. 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) 5. active primary hyperparathyroidism 6. hypothyroidism, not appropriately controlled with long-term thyroxine therapy 7. history of iritis or uveitis, except due to trauma, and resolved for > 2 years prior to study 8. self-reported history of diabetic nephropathy or retinopathy (if diabetic, Hb A1c > 10%) 9. urine dipstick greater than or equal to 2+ protein at screening 10. AST or ALT greater than twice the upper limit of normal and/or alkaline phosphatase greater than twice the upper limit of normal 11. serum calcium > 2.75 mmol/L (11.0 mg/dL) or < 2.00 mmol/L (8.0 mg/dL) 12. 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 13. 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 14. 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 15. women of childbearing potential not using the contraception method(s) specified in this study (specify), as well as women who are breastfeeding |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Australia | The Queen Elizabeth Hospital | Adelaide | South Australia |
Australia | Princess Alexandra Hospital | Brisbane | Queensland |
Australia | Royal Brisbane and Womens Hospital | Herston | Queensland |
Australia | Cabrini Hospital | Melbourne | Victoria |
Australia | Royal North Shore Hospital, Department of Rheumatology | Sydney | New South Wales |
Lead Sponsor | Collaborator |
---|---|
University of Sydney | Novartis |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | reducing pain and disability in the hip | 1 years | No | |
Secondary | reducing progression to femoral head collapse and the need for surgical intervention | 3 years | No |
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