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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
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:

U.S. FDA Resources

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 Not yet recruiting
Celje, Slovenia, 3000
Sponsors and Collaborators
Celje Teaching Hospital
Investigators
Principal Investigator: Samo K Fokter, MD, PhD Celje Teaching Hospital
  More Information

No publications provided

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

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

ClinicalTrials.gov processed this record on May 22, 2013