Bone loss occurring around cementless hip prosthesis in postmenopausal women treated for primary hip osteoarthritis
Conditions
Interventions
Trade Name: Aclasta
Pharmaceutical Form: Concentrate for solution for infusion
Other descriptive name: ZOLEDRONIC ACID ANHYDROUS
Concentration unit: mg milligram(s)
Concentration type: equal
Concentra
Sponsors
Hospital District of Southwest Finland
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;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. | — |
Countries
Finland
Outcome results
None listed