Femur Fracture Clinical Trial
Official title:
Radiographic Influences of Long-term Bisphosphonate Treatment on Femur
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | October 2018 |
Est. primary completion date | October 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 45 Years to 100 Years |
Eligibility |
Inclusion Criteria: - Patients using bisphosphonate more than four years Exclusion Criteria: - patients who could not use bisphosphonate |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Japan | Tomidahama Hospital | Yokkaichi | Mie |
Lead Sponsor | Collaborator |
---|---|
Tomidahama Hospital |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Influence of long-term bisphosphonate treatment on femur. | 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. |
Up to 24 month | Yes |
Secondary | Longitudinal effects of bisphosphonate treatments on femur | 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. |
Up to108 months | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03231787 -
Clinical Trial in Antiaggregated Patients With Proximal Femur Fracture Evaluating a Strategy to Shorten Time Until Surgery
|
N/A | |
Completed |
NCT00888160 -
Timing of Orthopaedic Surgery in the Multiply-injured Patient: Development of a Protocol for Early Appropriate Care
|
||
Completed |
NCT05613257 -
Distal Targeter vs Free-hand
|
N/A | |
Withdrawn |
NCT00240396 -
Bimodal Analgesia as Form of Pain Control Post Long Bone Fracture
|
N/A | |
Terminated |
NCT03160508 -
Trochanter Fixation Nail Advanced (TFNA) Weight Bearing
|
||
Completed |
NCT04127045 -
ProspEctive Cohort Study on Multidisciplinary Approach to Femur FRactures' manAgement in Over 65 Population
|
||
Recruiting |
NCT03868280 -
The FLiP Study, a Pilot Cluster Randomized Trial
|
N/A | |
Completed |
NCT00725894 -
Pediatric Locking Nail for the Treatment of Femoral Fractures in Children
|
N/A | |
Recruiting |
NCT04657510 -
Femoral frACturEs and COVID-19.
|
||
Completed |
NCT05225753 -
Post-operative Anemia in Lateral Fractures of the Femur.
|
||
Active, not recruiting |
NCT03775408 -
FAST: Clinical Feasibility
|
||
Completed |
NCT02793947 -
Efficacy of Peri-Incisional Multimodal Drug Injection Following Operative Management of Femur Fractures
|
Phase 4 | |
Completed |
NCT00916136 -
Skeletal Versus Cutaneous Traction For Treatment of Femur Fractures
|
N/A | |
Completed |
NCT06430944 -
Comparative Study Between Single and Double Limb Hip Spica Cast in Fracture Femur in Young Children
|
N/A | |
Completed |
NCT05183308 -
Combined Drug Therapy in Lateral Fragility Fractures of the Femur
|
||
Not yet recruiting |
NCT00616044 -
Continuous Spinal Anesthesia Versus Combined Spinal Epidural Block
|
N/A | |
Terminated |
NCT01484405 -
Anterolateral Versus Posterior Approach for Total Hip Arthroplasty After Displaced Femoral Neck Fracture
|
N/A | |
Completed |
NCT00943332 -
Pediatric Femur Research Project
|
||
Not yet recruiting |
NCT00686023 -
Comparing Surgical Techniques for CRIF of Pertrochanteric Fractures
|
N/A | |
Completed |
NCT01293916 -
Spica Casting in Pediatric Femur Fractures: Study of Single Leg Versus Double Leg Spica Casts
|
N/A |