Radiographic Influences of Long-term Bisphosphonate Treatment on Femur
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Tomidahama Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Influence of long-term bisphosphonate treatment on femur.
Study 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 45 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Investigators
Toshihiko Kono
Head of Hospital
Tomidahama Hospital