An Exploratory Randomized comparative clinical trial for the preventive effect of Denosumab versus Zoledronic acid against bone loss around femoral implants after total hip arthroplasty
- Conditions
- Patients with hip osteoarthritis or osteonecrosis who are undergoing total hip arthroplasty.
- Registration Number
- JPRN-UMIN000030571
- Lead Sponsor
- Yokohama City University, Orthopaedic Surgery
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
Not provided
1)Patients who have taken the following drugs for the treatment of osteoporosis: a)calcium, b)female hormone, c)activated vitamin D3, d)vitamin K, e)bisphosphonate, f)SERM, g)calcitonin, h)parathyroid hormone, PTH, i)Anti-RANKL antibody, j)Ipriflavone and k)Anabolic hormone 2)Patients diagnosed with rheumatoid arthritis; 3)Patients diagnosed with diabetes (HbA1c>7.6) within 14 days of pre-registration; 4)Patients who has/had suffered from urinary tract stones; 5)Patients who are having tooth extraction or an implant at the time of registration or during a study period; 6)Patients with liver dysfunction (GOT>36IU/L, GPT>36IU/L) within 14 days of pre-registration; 7)Patients with urinary dysfunction (creatinine clearance<35ml/min) within 14 days of pre-registration; 8)Patients with serum calcium level of less than 9.0 or more than of 10.2; 9)Patients with paralysis or a brain degenerative disease; 10)Patients with systemic infection; 11)Patients who cannot take medicine orally; 12)Patients with gastrointestinal disorder that might inhibit the absorption of medicines; 13)patients who are disqualified as sample for this research by principal and co-investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method