Radiographic Influences of Bisphosphonate Treatment on Femur

NCT01969279 | Unknown

• 1 other identifier: IRB TH No 6-2
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Femur Fracture

Keywords

Osteoporosis; Bisphosphonate; Atypical femoral fracture; Side effect

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Longitudinal effects of bisphosphonate treatments on femur

  Up to108 months

Eligibility Criteria

• Age: 45 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Oateoporosis patients using bisphosphonate more than four years.

You may qualify if:

• Patients using bisphosphonate more than four years

You may not qualify if:

• patients who could not use bisphosphonate

Sponsors & Collaborators

• Tomidahama Hospital: lead

Study Sites (1)

Tomidahama Hospital

Yokkaichi, Mie-ken, 510-8008, Japan

RECRUITING

MeSH Terms

Conditions

Femoral Fractures; Osteoporosis

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Rui Niimi, MD, PhD

CONTACT

(81)-59-365-0023; furikakefuri@hotmail.co.jp

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Hospital

Study Record Dates

• First Submitted: October 13, 2013
• First Posted: October 25, 2013
• Study Start: October 1, 2000
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2018
• Last Updated: October 19, 2016

Record last verified: 2016-10

Locations

JP (1)