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

General and Teaching Hospital Celje

Status and phase: Not yet enrolling; Phase 1

Conditions: Mineral Density; Arthroplasty

Treatments: Drug: pamidronate

Study type: Interventional

Funder types: Other

Identifiers

NCT00548288

PAM19382CE

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with hip arthritis scheduled for total cemented hip arthroplasty

Exclusion criteria

• pregnancy
• endoprosthesis on contralateral hip

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind