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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2007 by General and Teaching Hospital Celje.
Recruitment status was:  Not yet recruiting
Information provided by:
General and Teaching Hospital Celje Identifier:
First received: October 22, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
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 (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

Resource links provided by NLM:

Further study details as provided by General and Teaching Hospital Celje:

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

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

Inclusion Criteria:

  • patients with hip arthritis scheduled for total cemented hip arthroplasty

Exclusion Criteria:

  • pregnancy
  • endoprosthesis on contralateral hip
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00548288

Contact: Samo K Fokter, MD, PhD +38634233306

Department for Orthopaedic Surgery and Sports Trauma, Celje Teaching Hospital Not yet recruiting
Celje, Slovenia, 3000
Sponsors and Collaborators
General and Teaching Hospital Celje
Principal Investigator: Samo K Fokter, MD, PhD General and Teaching Hospital Celje
  More Information Identifier: NCT00548288     History of Changes
Other Study ID Numbers: PAM19382CE
Study First Received: October 22, 2007
Last Updated: October 22, 2007 processed this record on August 16, 2017