Radiographic Influences of Bisphosphonate Treatment on Femur

Overview

Although there is strong evidence that bisphosphonates prevent certain types of osteoporotic fractures, there are concerns that these medications may be associated with rare atypical femoral fractures (AFF). But the relationship between long-term bisphosphonate treatment and AFF is unclear. In this study, the investigators would like to analyze the long term effects on femur by bisphosphonate treatment.The participants are treated in the investigators hospital more than four years.

Full Title of Study: “Radiographic Influences of Long-term Bisphosphonate Treatment on Femur”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: October 2017

Detailed Description

Bisphosphonates have been widely used in the treatment of osteoporosis. Recently, long-term use of bisphosphonates increases the risk for AFFs in older women, according to the results of a population-based, nested case-control study. Unique radiographic pattern of AFF is reported, such as simple transverse or short oblique fracture with breaking of medial cortex and cortical thickness. But radiographic evaluation were performed for fracture patients in previous reports and the femoral condition of long-term bisphosphonate treatment patients before fracture is not known. The main objective of this study is to reveal the effects of long-term bisphosphonate treatment on femur.

Clinical Trial Outcome Measures

Primary Measures

  • Influence of long-term bisphosphonate treatment on femur.
    • Time Frame: Up to 24 month
    • The investigators plan to analyze 120 patients who undergo bisphosphonate treatments more than four years. We investigate radiographic features in patients with long-term bisphosphonate treatment. We investigate bilateral femur radiographs concerning to cortical thickening and cortical hypertrophy. We also investigate age and sex matched patients without bisphosphonate treatment as a control group. To determine the bisphosphonate treatment effects on femur, statistical analyses are performed using Spearman correlation, paired t-test, chi-square test, Fisher’s exact test and Mann-Whitney U test. Finally, we conclude the effects of bisphosphonate treatment on femur.

Secondary Measures

  • Longitudinal effects of bisphosphonate treatments on femur
    • Time Frame: Up to108 months
    • The investigators plan to analyze 100 patients who undergo bisphosphonate treatments more than four months. To enroll 300 participants including drop-out patients, up to 60 months is required beside 48 months treatment periods. In this study, we plan to evaluate longitudinal changes of femur. We evaluate femur radiographs at baseline and every one year. We investigate bilateral femur radiographs concerning to cortical thickening and cortical hypertrophy longitudinally. Statical analyses are performed using Spearman correlation coefficients, paired t-test, Mann-Whitney U test, chi-square test and Fisher’s exact test.

Participating in This Clinical Trial

Inclusion Criteria

  • Patients using bisphosphonate more than four years Exclusion Criteria:

  • patients who could not use bisphosphonate

Gender Eligibility: All

Minimum Age: 45 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Tomidahama Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Toshihiko Kono, Head of Hospital – Tomidahama Hospital
  • Overall Contact(s)
    • Rui Niimi, MD, PhD, (81)-59-365-0023, furikakefuri@hotmail.co.jp

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.