Arthroplasty, Mineral Density
Conditions
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.
Interventions
DRUGpamidronate
Sponsors
General and Teaching Hospital Celje
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* patients with hip arthritis scheduled for total cemented hip arthroplasty
Exclusion criteria
* pregnancy * endoprosthesis on contralateral hip
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Periprosthetic bone mineral density | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Biochemical markers of bone turnover | 6 months |
Countries
Slovenia
Contacts
Primary ContactSamo K Fokter, MD, PhD
Outcome results
None listed