Femur FractureNCT01969279
Radiographic Influences of Bisphosphonate Treatment on Femur
An observational study of Femur Fracture, run by Tomidahama Hospital at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Ages 45 to 100 years
- Conditions the study is for
- Femur Fracture
- How many people
- 100 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2000to Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Oateoporosis patients using bisphosphonate more than four years.
Who may be able to join
- Patients using bisphosphonate more than four years
Who cannot join
- patients who could not use bisphosphonate
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Tomidahama Hospital
Yokkaichi, Mie-ken, 510-8008
Rui Niimi, MD, PhD, (81)-59-365-0023, furikakefuri@hotmail.co.jp
About this study
Official title: Radiographic Influences of Long-term Bisphosphonate Treatment on Femur
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.
Read the detailed 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.
- Conditions
- Femur Fracture
- Keywords
- Osteoporosis, Bisphosphonate, Atypical femoral fracture, Side effect
- Medical subject headings
- Femoral Fractures, Osteoporosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 24 month
Secondary outcomes (1)
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.
Measured: Up to108 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2013 (estimated)
- Study startOct 2000
- Primary completionOct 2017 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femur FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tomidahama Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Toshihiko Kono, Tomidahama Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01969279
- Sponsor's protocol ID
- IRB TH No 6-2
- Status last verified
- Oct 2016
- First submitted
- 13 Oct 2013
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic Influences of Long-term Bisphosphonate Treatment on Femur
- ClinicalTrials.gov ID
- NCT01969279
- Acronym / sponsor ID
- IRB TH No 6-2
- Conditions
- Femur Fracture
- Keywords
- Osteoporosis, Bisphosphonate, Atypical femoral fracture, Side effect
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tomidahama HospitalUniversity, hospital or other
- Study start
- Oct 2000
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 25 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Oateoporosis patients using bisphosphonate more than four years.
Key inclusion criteria (1 listed)
- Patients using bisphosphonate more than four years
Key exclusion criteria (1 listed)
- patients who could not use bisphosphonate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Influence of long-term bisphosphonate treatment on femur.
Time frame: Up to 24 month
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.
1 secondary outcome
Longitudinal effects of bisphosphonate treatments on femur
Time frame: Up to108 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2016.
Related trials for Femur Fracture
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
Not yet recruiting
Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures
Tibial Fracture, Femoral Fracture
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Enrolling by invitationObservational study
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
Osteoporosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femur Fracture, run by Tomidahama Hospital at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rui Niimi, MD, PhD ((81)-59-365-0023, furikakefuri@hotmail.co.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influence of long-term bisphosphonate treatment on femur. (time frame: Up to 24 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2016.