Status:
COMPLETED
Efficacy of Zoledronic Acid in Enhancement of Early Stability of Cementless Primary Hip Prosthesis
Lead Sponsor:
Turku University Hospital
Collaborating Sponsors:
Academy of Finland
Novartis
Conditions:
Hip Osteoarthritis
Eligibility:
FEMALE
20+ years
Phase:
PHASE4
Brief Summary
This is a randomized, double-blind and placebo-controlled study to evaluate the efficacy of zoledronic acid on the biologic incorporation of cementless hip prosthesis in postmenopausal female patients...
Detailed Description
All the patients enrolled in the study will receive the standard of care with respect to surgical prosthetic replacement of the diseased hip. The patients will receive a custom-modified (RSA marked) h...
Eligibility Criteria
Inclusion
- Degenerative hip osteoarthritis as the indication for hip replacement
- Postmenopausal female patient
- Age of at least 20 years
- Signed Informed Consent
Exclusion
- Evidence of secondary osteoporosis
- Clinical or laboratory evidence of hepatic or renal disease
- Disorders of parathyroid function, or D-vitamin metabolism
- History of malignancy, radiotherapy, or chemotherapy for malignancy (except for basal cell carcinoma of the skin) within the past 5 years
- No metastatic cancer or cancer diagnosed less than 2 years ago where treatment is still ongoing
- Administration for more than 7 days of drugs, which may interfere with bone metabolism:
- cumulative dose of 500 mg of prednisone or equivalent within the last 6 months
- calcitonin within the last 6 months
- bisphosphonates for 30 days or more within the last 12 months
- bone therapeutic doses of fluoride for 30 days or more within the last 24 months
- Rheumatoid arthritis or any other inflammatory arthritis
- History of osteogenesis imperfecta, multiple myeloma, or Paget's disease
- Active primary hyperparathyroidism
- History of uveitis, iritis, or chronic conjunctivitis
- History of retinopathy or nephropathy, especially in the presence of uncontrollable IDDM (Hb1AC \> 10%)
- AST or ALT \> 2X the upper limit of normal
- ALP \> 1.5X the upper limit of normal
- Serum creatine \> 2 mg/dl
- Creatine clearance \< 40 ml/min
- Serum calcium \> 11.0 mg/dL and \< 8mg/dL
- Serum 25(OH)D \< 15 ng/ml
- In subjects with HIV must have a plasma HIV-1 RNA level of \< 5000, a CD4+ count of \> 100 cells/mm3m and be receiving stable ART for a minimum of 12 weeks prior study entry, with no plan at study entry to significantly alter ART
- Allergy to zoledronic acid
- Severe dental problems or current dental infections or with recent or impending dental surgery within three months of dosing
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT01218035
Start Date
May 1 2007
End Date
June 1 2011
Last Update
February 13 2017
Active Locations (1)
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1
Turku University Hospital
Turku, Finland, 20520