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Sponsored by: |
Celje Teaching Hospital |
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Information provided by: | Celje Teaching Hospital |
ClinicalTrials.gov Identifier: | NCT00548288 |
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 |
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Arthroplasty Mineral Density |
Drug: pamidronate |
Phase I |
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 |
Ages Eligible for Study: | 50 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Samo K Fokter, MD, PhD | +38634233306 | samo.fokter@guest.arnes.si |
Slovenia | |
Department for Orthopaedic Surgery and Sports Trauma, Celje Teaching Hospital | |
Celje, Slovenia, 3000 |
Principal Investigator: | Samo K Fokter, MD, PhD | Celje Teaching Hospital |
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 |
Pamidronate |
Physiological Effects of Drugs Bone Density Conservation Agents Pharmacologic Actions |