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Radiographic Influences of Bisphosphonate Treatment on Femur

NCT ID: NCT01969279

Last Updated: 2016-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-10-31

Study Completion Date

2018-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Femur Fracture

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients using bisphosphonate more than four years

Exclusion Criteria

* patients who could not use bisphosphonate
Minimum Eligible Age

45 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tomidahama Hospital

OTHER

Sponsor Role lead

Responsible Party

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Toshihiko Kono

Head of Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tomidahama Hospital

Yokkaichi, Mie-ken, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Rui Niimi, MD, PhD

Role: CONTACT

[email protected]
(81)-59-365-0023

Facility Contacts

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Rui Niimi, MD, PhD

Role: primary

[email protected]
(81)-59-365-0023

Other Identifiers

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IRB TH No 6-2

Identifier Type: -

Identifier Source: org_study_id

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