MedTrace Logo

Effect of Local Pamidronate in Preventing Bone Loss After Total Hip Arthroplasty

NCT00548288 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-04-15

No results posted yet for this study

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.

Conditions

  • Arthroplasty
  • Mineral Density

Interventions

DRUG

pamidronate

Sponsors & Collaborators

  • General and Teaching Hospital Celje

    lead OTHER

Principal Investigators

  • Samo K Fokter, MD, PhD · General and Teaching Hospital Celje

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30

Countries

  • Slovenia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00548288 on ClinicalTrials.gov