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

NCT ID: NCT00548288

Last Updated: 2024-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Arthroplasty Mineral Density

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Interventions

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pamidronate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients with hip arthritis scheduled for total cemented hip arthroplasty

Exclusion Criteria

* pregnancy
* endoprosthesis on contralateral hip
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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General and Teaching Hospital Celje

OTHER

Sponsor Role lead

Principal Investigators

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Samo K Fokter, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

General and Teaching Hospital Celje

Locations

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Department for Orthopaedic Surgery and Sports Trauma, Celje Teaching Hospital

Celje, , Slovenia

Site Status

Countries

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Slovenia

Central Contacts

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Samo K Fokter, MD, PhD

Role: CONTACT

[email protected]
+38634233306

Other Identifiers

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PAM19382CE

Identifier Type: -

Identifier Source: org_study_id

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