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NCT00548288 Clinical Trial

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

Arthroplasty Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00548288
Other study ID # PAM19382CE
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date November 2007

Study information
Verified date April 2024
Source General and Teaching Hospital Celje
Contact Samo K Fokter, MD, PhD
Phone +38634233306
Email samo.fokter@guest.arnes.si
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 50 Years to 80 Years
Eligibility Inclusion Criteria: - patients with hip arthritis scheduled for total cemented hip arthroplasty Exclusion Criteria: - pregnancy - endoprosthesis on contralateral hip

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• pamidronate

Locations
Country Name City State
Slovenia Department for Orthopaedic Surgery and Sports Trauma, Celje Teaching Hospital Celje

Sponsors (1)
Lead Sponsor Collaborator
General and Teaching Hospital Celje

Country where clinical trial is conducted

Slovenia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Periprosthetic bone mineral density 6 months
Secondary Biochemical markers of bone turnover 6 months
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