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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2007 by Celje Teaching Hospital.
Recruitment status was Not yet recruiting

Sponsor:

Information provided by:

Celje Teaching Hospital

ClinicalTrials.gov Identifier:

NCT00548288

First received: October 22, 2007

Last updated: NA

Last verified: October 2007

History: No changes posted

Tracking Information

First Received Date ^ICMJE

October 22, 2007

Last Updated Date

October 22, 2007

Start Date ^ICMJE

November 2007

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Periprosthetic bone mineral density [ Time Frame: 6 months ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Biochemical markers of bone turnover [ Time Frame: 6 months ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Arthroplasty
Mineral Density

Intervention ^ICMJE

Drug: pamidronate

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

patients with hip arthritis scheduled for total cemented hip arthroplasty

Exclusion Criteria:

pregnancy
endoprosthesis on contralateral hip

Gender

Both

Ages

50 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Samo K Fokter, MD, PhD

+38634233306

samo.fokter@guest.arnes.si

Location Countries ^ICMJE

Slovenia

Administrative Information

NCT Number ^ICMJE

NCT00548288

Other Study ID Numbers ^ICMJE

PAM19382CE

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Celje Teaching Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Samo K Fokter, MD, PhD

Celje Teaching Hospital

Information Provided By

Celje Teaching Hospital

Verification Date

October 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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