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Clinical Trials/NCT01969279
NCT01969279
Unknown
Not Applicable

Radiographic Influences of Long-term Bisphosphonate Treatment on Femur

Tomidahama Hospital1 site in 1 country100 target enrollmentOctober 2000
ConditionsFemur Fracture

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Femur Fracture
Sponsor
Tomidahama Hospital
Enrollment
100
Locations
1
Primary Endpoint
Influence of long-term bisphosphonate treatment on femur.
Last Updated
9 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
October 2000
End Date
October 2018
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Toshihiko Kono

Head of Hospital

Tomidahama Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients using bisphosphonate more than four years

Exclusion Criteria

  • patients who could not use bisphosphonate

Outcomes

Primary Outcomes

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 Outcomes

  • Longitudinal effects of bisphosphonate treatments on femur(Up to108 months)

Study Sites (1)

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