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Age-related Cognitive Change of Femur

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ClinicalTrials.gov Identifier: NCT02220322
Recruitment Status : Recruiting
First Posted : August 19, 2014
Last Update Posted : October 19, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Age-related change of femur is not well-known. The investigators investigated the longitudinal changes of femur.

Condition or disease
Osteoporosis

Detailed 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.


Study Design

Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Age-related Cognitive Change of Femur
Study Start Date : October 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : July 2017
Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Age-related change of femur [ Time Frame: Up to 12 months ]

    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.



Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Osteoporosis or osteopenia patients
Criteria

Inclusion Criteria:

  • Osteoporosis or osteopenia patients who presented to our hospital

Exclusion Criteria:

  • Patients without osteoporosis or osteopenia
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220322


Contacts
Contact: Rui Niimi, MD, PhD (81)-59-365-0023 furikakefuri@hotmail.co.jp

Locations
Japan
Tomidahama Hospital Recruiting
Yokkaichi, Mie, Japan, 510-8008
Contact: Rui Niimi, MD, PhD    (81)-59-365-0023    furikakefuri@hotmail.co.jp   
Sponsors and Collaborators
Tomidahama Hospital
Investigators
Principal Investigator: Rui Niimi, PhD Tomidahama Hospital
More Information

Responsible Party: Toshihiko Kono, Head of Hospital, Tomidahama Hospital
ClinicalTrials.gov Identifier: NCT02220322     History of Changes
Other Study ID Numbers: IRB TH No 9
First Posted: August 19, 2014    Key Record Dates
Last Update Posted: October 19, 2016
Last Verified: October 2016

Keywords provided by Toshihiko Kono, Tomidahama Hospital:
cortical thickness
age

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases