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

NCT00548288 | Not Yet Recruiting Phase 1

• 1 other identifier: PAM19382CE
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthroplasty; Mineral Density

Outcome Measures

Primary Outcomes (1)

• Periprosthetic bone mineral density

  6 months

Secondary Outcomes (1)

• Biochemical markers of bone turnover

  6 months

Interventions

pamidronate DRUG

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with hip arthritis scheduled for total cemented hip arthroplasty

You may not qualify if:

• pregnancy
• endoprosthesis on contralateral hip

Sponsors & Collaborators

• General and Teaching Hospital Celje: lead

Study Sites (1)

Department for Orthopaedic Surgery and Sports Trauma, Celje Teaching Hospital

Celje, 3000, Slovenia

Location

MeSH Terms

Interventions

Pamidronate

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Officials

• Samo K Fokter, MD, PhD

  General and Teaching Hospital Celje

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samo K Fokter, MD, PhD

CONTACT

+38634233306; samo.fokter@guest.arnes.si

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 22, 2007
• First Posted: October 23, 2007
• Study Start: November 1, 2007
• Last Updated: April 15, 2024

Record last verified: 2024-04

Locations

SL (1)