Fractures, BoneNCT05138640
Bone Strength and Physical Activity in Patients With a Recent Clinical Fracture
An observational study of Fractures, Bone and Patient Fall, run by Joop P.W. van den Bergh at 1 site in Netherlands.
Trial summary
The risk for a subsequent fracture is significantly higher in patients presenting with a fracture compared to individuals without a previous fracture and is highest within the first 2 years after the initial fracture. The risk for a subsequent fracture is not dependent of BMD as measured by conventional DXA. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Fractures, Bone, Patient Fall, Osteoporosis
- What is being tested?
- Not applicable. The study is designed as an observational cohort study
- How many people
- 500 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2014to Jul 2019
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a recent fracture evaluated at the FLS at VieCuri MC Venlo
Who may be able to join
- Patients aged 50 years and older with a recent fracture that is being evaluated at the FLS at VieCuri MC.
- Patients who understand the conditions of the study and are willing and able to comply with the scheduled biochemical study procedures
- Patients who signed the Ethics Committee approved specific Informed Consent Form prior to inclusion.
Who cannot join
- Patients with malignancy metastatic to the bone.
- Patients with osteomyelitis.
- Patients with fractures due to failure of a prosthesis.
- Patients, who as judged by the Principal Investigator, are mentally incompetent. Patients who are compos mentis and understand the patient information, will not be considered mentally incompetent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Evaluation of Bone Strength, Physical Activity, Falls, Subsequent Fractures and Mortality in Patients Presenting With a Recent Clinical Fracture
The risk for a subsequent fracture is significantly higher in patients presenting with a fracture compared to individuals without a previous fracture and is highest within the first 2 years after the initial fracture. The risk for a subsequent fracture is not dependent of BMD as measured by conventional DXA. In recent studies, it has been shown that HRpQCT measurements provide information about bone structure, bone quality and bone strength in addition to BMD measurements. Diagnostic strategies should be focussed on bone quality and bone strength and fall prediction in the patients at high risk for falls, subsequent fracture and mortality such as patients with a recent fracture. Therefore, the investigators conduct a prospective observational study in 500 patients aged 50 years and older who present with a clinical fracture for evaluation of bone strength, physical activity, falls, subsequent fractures and mortality during a follow-up period of 3 years.
- Conditions
- Fractures, Bone, Patient Fall, Osteoporosis, Physical Activity
- Being tested
- Not applicable. The study is designed as an observational cohort study
- Medical subject headings
- Fractures, Bone, Osteoporosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable. The study is designed as an observational cohort studyOther
Not applicable. The study is desigend as an observational cohort study
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone strength assessed with HRpQCT
Difference in bone strength, estimated by micro-finite element analyses, will be compared between patients with and without a subsequent fracture within 3 years of follow-up.
Measured: 3 years
Secondary outcomes (2)
Subsequent falls within 3 years after a fracture
Number of patients sustaining a new fall during 3 years of follow-up.
Measured: 3 years
Mortality
Number of patients deceased during 3 years of follow-up
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study startOct 2014
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractures, BoneStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joop P.W. van den Bergh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joop P.W. van den Bergh, VieCuri Medical Centre
- Investigators
- J PW van den Bergh, MD, PhD, Principal investigator, VieCuri Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138640
- Sponsor's protocol ID
- NL45707.072.13
- Status last verified
- Nov 2021
- First submitted
- 26 Sep 2014
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Bone Strength, Physical Activity, Falls, Subsequent Fractures and Mortality in Patients Presenting With a Recent Clinical Fracture
- ClinicalTrials.gov ID
- NCT05138640
- Acronym / sponsor ID
- NL45707.072.13
- Conditions
- Fractures, Bone, Patient Fall, Osteoporosis, Physical Activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Joop P.W. van den BerghUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 1 Dec 2021 (actual)
- 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.
The risk for a subsequent fracture is significantly higher in patients presenting with a fracture compared to individuals without a previous fracture and is highest within the first 2 years after the initial fracture. The risk for a subsequent fracture is not dependent of BMD as measured by conventional DXA. In recent studies, it has been shown that HRpQCT measurements provide information about bone structure, bone quality and bone strength in addition to BMD measurements. Diagnostic strategies should be focussed on bone quality and bone strength and fall prediction in the patients at high risk for falls, subsequent fracture and mortality such as patients with a recent fracture. Therefore, the investigators conduct a prospective observational study in 500 patients aged 50 years and older who present with a clinical fracture for evaluation of bone strength, physical activity, falls, subsequent fractures and mortality during a follow-up period of 3 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a recent fracture evaluated at the FLS at VieCuri MC Venlo
Key inclusion criteria (3 listed)
- Patients aged 50 years and older with a recent fracture that is being evaluated at the FLS at VieCuri MC.
- Patients who understand the conditions of the study and are willing and able to comply with the scheduled biochemical study procedures
- Patients who signed the Ethics Committee approved specific Informed Consent Form prior to inclusion.
Key exclusion criteria (4 listed)
- Patients with malignancy metastatic to the bone.
- Patients with osteomyelitis.
- Patients with fractures due to failure of a prosthesis.
- Patients, who as judged by the Principal Investigator, are mentally incompetent. Patients who are compos mentis and understand the patient information, will not be considered mentally incompetent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable. The study is designed as an observational cohort studyNot applicable. The study is desigend as an observational cohort study | Other | – |
Primary outcome
Bone strength assessed with HRpQCT
Time frame: 3 years
Difference in bone strength, estimated by micro-finite element analyses, will be compared between patients with and without a subsequent fracture within 3 years of follow-up.
2 secondary outcomes
Subsequent falls within 3 years after a fracture
Time frame: 3 years
Mortality
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
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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.
J PW van den Bergh, MD, PhD principal investigator
VieCuri Medical Centre
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 Fractures, Bone and Patient Fall, run by Joop P.W. van den Bergh at 1 site in Netherlands.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 1 Dec 2021. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone strength assessed with HRpQCT (time frame: 3 years). 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 1 Dec 2021.