Effect of Local Pamidronate in Preventing Bone Loss After Total Hip Arthroplasty
- Conditions
- Mineral DensityArthroplasty
- Registration Number
- NCT00548288
- Lead Sponsor
- General and Teaching Hospital Celje
- Brief Summary
The aims of the study are to determine whether pamidronate applied locally causes diminished periprosthetic bone loss and decreased rate of bone turnover compared to patients receiving placebo after cemented total hip arthroplasty (THA). The study design will be prospective, randomized, and blind. Periprosthetic bone mineral density (BMD) will be measured with dual energy X-ray absorptiometry (DXA) at the total periprosthetic area as well as at seven Gruen zones or regions of interest. DXA scans will be performed at one week (baseline), three months, and six months postoperatively. Mean values of biochemical markers of bone turnover, BMD, and baseline-normalized BMD values will be compared between the bisphosphonate and placebo groups at each time point. For all temporal measurements including bone markers, BMD and normalized BMD, mean values will be compared across each time point within a given group.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
- patients with hip arthritis scheduled for total cemented hip arthroplasty
- pregnancy
- endoprosthesis on contralateral hip
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Periprosthetic bone mineral density 6 months
- Secondary Outcome Measures
Name Time Method Biochemical markers of bone turnover 6 months
Trial Locations
- Locations (1)
Department for Orthopaedic Surgery and Sports Trauma, Celje Teaching Hospital
🇸🇮Celje, Slovenia