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

• Sponsor: General and Teaching Hospital Celje (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00548288
• Collaborator: (none)
• Enrollment: 40
• Location: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arthroplasty; Mineral Density	Drug: pamidronate	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Phase 1 Study of the Effect of Local Pamidronate Application in Preventing Periprosthetic Bone Loss After Total Cemented Hip Arthroplasty
• Study Start Date: Nov 1, 2007

Outcome Measures

Primary Outcome Measures

1. Periprosthetic bone mineral density [6 months]

Secondary Outcome Measures

1. Biochemical markers of bone turnover [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• patients with hip arthritis scheduled for total cemented hip arthroplasty

Exclusion Criteria:

• pregnancy

• endoprosthesis on contralateral hip

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department for Orthopaedic Surgery and Sports Trauma, Celje Teaching Hospital	Celje		Slovenia	3000

Sponsors and Collaborators

• General and Teaching Hospital Celje

Investigators

• Principal Investigator: Samo K Fokter, MD, PhD, General and Teaching Hospital Celje

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00548288
• Other Study ID Numbers: PAM19382CE
• First Posted: Oct 23, 2007
• Last Update Posted: Oct 23, 2007
• Last Verified: Oct 1, 2007

• Additional relevant MeSH terms: Pamidronate

Study Results

No Results Posted as of Oct 23, 2007