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Effect of Local Pamidronate in Preventing Bone Loss After Total Hip Arthroplasty
This study is not yet open for participant recruitment.
Verified by Celje Teaching Hospital, October 2007
Sponsored by: Celje Teaching Hospital
Information provided by: Celje Teaching Hospital
ClinicalTrials.gov Identifier: NCT00548288
  Purpose

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 Intervention Phase
Arthroplasty
Mineral Density
Drug: pamidronate
Phase I

MedlinePlus related topics: Minerals
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject), Parallel Assignment
Official Title: Phase 1 Study of the Effect of Local Pamidronate Application in Preventing Periprosthetic Bone Loss After Total Cemented Hip Arthroplasty

Further study details as provided by Celje Teaching Hospital:

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

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

Estimated Enrollment: 40
Study Start Date: November 2007
  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Celje, Slovenia, 3000
Sponsors and Collaborators
Celje Teaching Hospital
Investigators
Principal Investigator: Samo K Fokter, MD, PhD Celje Teaching Hospital
  More Information

Study ID Numbers: PAM19382CE
Study First Received: October 22, 2007
Last Updated: October 22, 2007
ClinicalTrials.gov Identifier: NCT00548288  
Health Authority: Slovenia: Agency for Medicinal Products - Ministry of Health

Study placed in the following topic categories:
Pamidronate

Additional relevant MeSH terms:
Physiological Effects of Drugs
Bone Density Conservation Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009