Femur Fracture
Conditions
Keywords
Osteoporosis, Bisphosphonate, Atypical femoral fracture, Side effect
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.
Interventions
None listed
Sponsors
Tomidahama Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patients using bisphosphonate more than four years
Exclusion criteria
* patients who could not use bisphosphonate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Influence of long-term bisphosphonate treatment on femur. | 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
| Measure | Time frame | Description |
|---|---|---|
| Longitudinal effects of bisphosphonate treatments on femur | 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. |
Countries
Japan
Contacts
Primary ContactRui Niimi, MD, PhD
Outcome results
None listed