Efficacy of Zoledronic Acid in Enhancement of Early Stability of Cementless Primary Hip Prosthesis

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: Female

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.The study population consists of postmenopausal female patients scheduled for total hip replacement because of degenerative hip osteoarthritis. The patients will receive either a single dose of 5 mg zoledronic acid or placebo intravenously after surgery before hospital discharge. The patients will be followed-up for 1 year. Zoledronic acid therapy has been shown to promote bone ingrowth into porous implants in pre-clinical models. The investigators hypothesis is that zoledronic acid, given as a single intravenous infusion after hip replacement surgery, enhances bone ingrowth into porous surface of cementless hip prostheses. As a primary outcome, the therapy is expected to reduce periprosthetic bone loss measured by DXA. Enhancement of bone ingrowth is expected to increase primary stability of the hip prosthesis and this effect can be detected with high-precision three-dimensional RSA imaging modality and in a faster functional recovery of the patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Turku University Hospital
• Collaborators: Academy of Finland; Novartis; Stryker Nordic
• Treatments: Diphosphonates; Zoledronic Acid

Criteria

Inclusion Criteria:

• Degenerative hip osteoarthritis as the indication for hip replacement

• Postmenopausal female patient

• Age of at least 20 years

• Signed Informed Consent

Exclusion Criteria:

• 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