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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02220322
Other study ID # IRB TH No 9
Secondary ID
Status Recruiting
Phase N/A
First received August 18, 2014
Last updated October 18, 2016
Start date October 2013
Est. completion date July 2017

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 [Patient Registry]

Clinical Trial Summary

Age-related change of femur is not well-known. The investigators investigated the longitudinal changes of femur.


Description:

Recently, bisphosphonate-related atypical fracture of femur (AFF) is paid attention in clinicians. Almost all AFFs were occurred in thicker cortical thickness. But age-related change of femur is not well-known.

The main objective of this study is to reveal the age-related change of femur.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date July 2017
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years and older
Eligibility Inclusion Criteria:

- Osteoporosis or osteopenia patients who presented to our hospital

Exclusion Criteria:

- Patients without osteoporosis or osteopenia

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


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 Age-related change of femur We investigate radiographic features in patients with osteopenia/opsteoporosis. We investigate bilateral femur radiographs concerning to cortical thickening. We analyze age-related change of femur.
To determine the age-related change of 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 age on femur.
Up to 12 months Yes
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