A randomized, double-blind, placebo-controlled study to evaluate the efficacy of zoledronic acid in enhancement of early stability of cementless primary hip prosthesis - Aclasta Hip Prosthesis
- Conditions
- Bone loss occurring around cementless hip prosthesis in postmenopausal women treated for primary hip osteoarthritis
- Registration Number
- EUCTR2006-002557-68-FI
- Lead Sponsor
- Hospital District of Southwest Finland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Key Inclusion Criteria:
- Degenerative hip osteoarthritis as the indication for hip replacement
- Postmenopausal female patient
- Age of at least 20 years
- Signed Informed Consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to demonstrate that a single dose of zoledronic acid reduces periprosthetic bone loss measured by DXA. ;Secondary Objective: The secondary objectives are to demonstrate that the treatment can enhance biologic incorporation of cementless hip prostheses as shown by reduced prosthetic migration measured by RSA (radiostereometry), to demonstrate that enhanced incorporation of the hip prostheses following the therapy lead to faster functional recovery and better subjective outcome of the procedure, and to demonstrate that the treatment suppresses biochemical markers of bone resorption.<br>;Primary end point(s): As the primary radiologic endpoint, to detect any difference between the patient groups in prosthetic incorporation with the surrounding bone, sequential DXA measurements will be performed to delineate the effect of zoledronic acid therapy in prevention of periprosthetic bone mineral loss at each follow-up visit.
- Secondary Outcome Measures
Name Time Method