Radiographic Influences of Bisphosphonate Treatment on Femur

Femur Fracture Clinical Trial

Official title:

Radiographic Influences of Long-term Bisphosphonate Treatment on Femur

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01969279
• Other study ID #: IRB TH No 6-2
• Status: Recruiting
• Phase: N/A
• First received: October 13, 2013
• Last updated: October 18, 2016
• Start date: October 2000
• Est. completion date: October 2018

Study information

• Verified date: October 2016
• Source: Tomidahama Hospital
• Contact: Rui Niimi, MD, PhD
• Phone: (81)-59-365-0023
• Email: furikakefuri[@]hotmail.co.jp
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Femoral Fractures
• Femur Fracture

Locations

Country	Name	City	State
Japan	Tomidahama Hospital	Yokkaichi	Mie

Sponsors (1)

Lead Sponsor	Collaborator
Tomidahama Hospital

Country where clinical trial is conducted

Japan, 

Outcome

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