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

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ClinicalTrials.gov Identifier: NCT00548288
Recruitment Status : Unknown
Verified October 2007 by General and Teaching Hospital Celje.
Recruitment status was:  Not yet recruiting
First Posted : October 23, 2007
Last Update Posted : October 23, 2007
Sponsor:
Information provided by:

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  (Clinical Trial)
Estimated 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 : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Periprosthetic bone mineral density [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Biochemical markers of bone turnover [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with hip arthritis scheduled for total cemented hip arthroplasty

Exclusion Criteria:

  • pregnancy
  • endoprosthesis on contralateral hip
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00548288


Contacts
Contact: Samo K Fokter, MD, PhD +38634233306 samo.fokter@guest.arnes.si

Locations
Slovenia
Department for Orthopaedic Surgery and Sports Trauma, Celje Teaching Hospital Not yet recruiting
Celje, Slovenia, 3000
Sponsors and Collaborators
General and Teaching Hospital Celje
Investigators
Principal Investigator: Samo K Fokter, MD, PhD General and Teaching Hospital Celje
More Information

ClinicalTrials.gov Identifier: NCT00548288     History of Changes
Other Study ID Numbers: PAM19382CE
First Posted: October 23, 2007    Key Record Dates
Last Update Posted: October 23, 2007
Last Verified: October 2007