Trial | NCT00548288  Report issue

Title

Effect of Local Pamidronate in Preventing Bone Loss After Total Hip Arthroplasty
Phase 1 Study of the Effect of Local Pamidronate Application in Preventing Periprosthetic Bone Loss After Total Cemented Hip Arthroplasty

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    40
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.
Study Started
Nov 30
2007
Last Update
Oct 23
2007
Estimate

Drug pamidronate

Criteria 

Inclusion Criteria:

patients with hip arthritis scheduled for total cemented hip arthroplasty

Exclusion Criteria:

pregnancy
endoprosthesis on contralateral hip
No Results Posted