OsteoporosisNCT02332681
Osteoporosis and Knee Insufficiency Fracture
An observational study of Osteoporosis and Osteoporotic Fractures, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Osteoporosis is a systemic bone disease characterized by low bone mass and microarchitectural deterioration of bone tissue with consequent bone fragility and susceptibility to fracture. Fifty percent of women and 20% men older than 50 y.o. will have an osteoporotic fracture (fragility fracture). Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Osteoporosis, Osteoporotic Fractures, Osteonecrosis
- How many people
- 300 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2014to Dec 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients older than 45 years, with sudden joint line knee pain without high trauma history, with or without a history of osteoarthritis and / or osteoporosis.
Who may be able to join
- patients who seek orthopedics service with sudden onset of pain in the knee;
- age of 45 y.o. or more
- acceptance by signing the informed consent form.
Who cannot join
- acute trauma of knee
- other etiologies (post-traumatic, infectious, inflammatory diseases)
- pregnant women
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University of Campinas
Campinas, São Paulo, 13083-888
Gustavo C Campos, Phd, +5519983318000, gustavoccampos@terra.com.br
Alessandro R Zorzi, Msc, +5519992809303, zorzi@fcm.unicamp.br
About this study
Osteoporosis is a systemic bone disease characterized by low bone mass and microarchitectural deterioration of bone tissue with consequent bone fragility and susceptibility to fracture. Fifty percent of women and 20% men older than 50 y.o. will have an osteoporotic fracture (fragility fracture). Fragility fracture is defined as one that results from a low-energy trauma such as a fall from body height. A previous fracture is an important predictor of a new fracture, especially in the first 5 years after initial fracture. A second fracture can be particularly devastating if it is a hip fracture. Low bone mineral density, measured by bone densitometry, as well as a previous osteoporotic fracture, are the two major risk factors for the occurrence of a new fracture.
A more rational approach currently used to minimize the costs of health care in a shorter period of time uses the strategy of firstly preventing the occurrence of secondary fracture, followed by primary prevention strategies. In this context, correct identification of fragility fractures and consequent treatment of those individuals is imperative. There are currently insufficient data about the epidemiology and evolution of other fragility fractures, also known as non-vertebral non-hip fracture (NVNH). Among these, distal radius fracture and proximal humerus fractures are the most frequent. There is a type of fracture, however, that is simply ignored by the medical community: the knee insufficiency fracture.A possible explanation for this information gap could be the fact that, until a few years ago, this entity was believed to be a osteonecrosis of the knee. Only recently it is becoming clear that the cause of pain and marrow bone edema that occur subtly in older individuals is, in fact, a insufficiency fracture. The perception that this lesion is actually a fracture is relatively new. The knee insufficiency fracture usually occurs in older individuals and those with knee osteoarthritis. This study therefore aims to evaluate whether there is a relation between knee insufficiency fracture and osteoporosis. Moreover, it is expected to find out if this fracture may be defined as a fragility fracture, electing the individuals affected by it to a prophylaxis for the occurrence of new osteoporotic fracture.
Read the detailed description
Osteoporosis is a systemic bone disease characterized by low bone mass and microarchitectural deterioration of bone tissue with consequent bone fragility and susceptibility to fractures. Fifty percent of women and 20% of men older than 50 y.o. will have an osteoporotic fracture (fragility fracture). Fragility fracture is defined as one that results from a low-energy trauma such as a fall from body height. A previous fracture is an important predictor of a new fracture, especially in the first 5 years after the initial fracture. A second fracture can be particularly devastating if a hip fracture. Approximately 25% of individuals with hip fracture die in five years and only half of them recover the pre-fracture status, meaning loss of ambulation ability and independence in domestic activities. In addition, fragility fractures generate significant cost to the health system - the annual cost of osteoporotic fractures in patients older than 50 years in the United States is estimated at 1.3 billion dollar.
Low bone mineral density, measured by bone densitometry, as well as a previous osteoporotic fracture, are the two major risk factors for the occurrence of a new fracture. A crucial observation is that fracture attracts fracture, ie, individuals who had a fragility fracture are twice as likely to suffer a second fracture and half of patients with a hip fracture had previously broken another bone. Therefore, a more rational approach currently used to minimize the costs of health care more effectively and in a short time uses firstly the strategy of preventing the occurrence of secondary fracture, followed by primary prevention strategies. In this context, the correct identification of fragility fractures and the consequent treatment of individuals makes it imperative. However, it is surprising and discouraging the information that despite the huge range of currently available treatments, most patients who sustain a fragility fracture does not receive treatment.
Vertebral fractures and hip has undoubtedly the greatest impact on walking ability of the elderly, and great attention is given to these two types of fracture. Consequently, there are currently insufficient data on the epidemiology and evolution of other fragility fractures, also known as non-vertebral non-hip fracture (NVNH). Among these, distal radius and proximal humerus fractures are the most frequent. There is a type of fracture, however, that is simply ignored by the medical community: the knee insufficiency fracture. The fact that no literature study even hypothesize that this type of fracture may be a fragility fracture may be because, until a few years ago, it was believed that this entity was a osteonecrosis of the knee. The knee insufficiency fracture usually occurs in older individuals and those with knee osteoarthritis. This study therefore aims to evaluate whether a relation between the knee insufficiency fracture and osteoporosis. Moreover, it is expected to find out if this fracture may be defined as a fragility fracture, electing the individuals affected by it to a prophylaxis for the occurrence of new osteoporotic fracture.
BACKGROUND
The knee insufficiency fracture usually occurs in older individuals and those with knee osteoarthritis. Currently no literature study even suggests the hypothesis that this type of fracture may be a fragility fracture. A possible explanation for this information gap could be the fact that, until a few years ago, this entity was believed to be a osteonecrosis of the knee. Only recently it is becoming clear that the cause of pain and marrow bone edema that occur subtly in older individuals is, in fact, a insufficiency fracture. This study therefore aims to evaluate whether a relation between the knee insufficiency fracture and osteoporosis. Moreover, it is expected to find out if this fracture may be defined as a fragility fracture, electing the individuals affected by it to a prophylaxis for the occurrence of new osteoporotic fracture.
OBJECTIVES
The objective of this study is to evaluate whether there is a relationship between the knee insufficiency fracture and osteoporosis.
EXPECTED FINDINGS
Patients with knee insufficiency fracture have a higher prevalence of osteoporosis than the general population.
Patients with knee insufficiency fracture have a higher risk of having a second osteoporotic fracture
- Conditions
- Osteoporosis, Osteoporotic Fractures, Osteonecrosis
- Medical subject headings
- Osteoporosis, Osteoporotic Fractures, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| With insufficiency fracture | Patients with acute pain that sustained a knee insufficiency fracture | |
| Without insufficiency fracture | Patients with acute pain that did not sustained a knee insufficiency fracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
New fracture
Occurrence of a new fragility fracture
Measured: 12 months
Secondary outcomes (1)
Bone Mineral Density
Evolution of bone mineral density results
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Campinas, Brazil
- Responsible party
- Sponsor
- Investigators
- Gustavo C Campos, Phd, Principal investigator, University of Campinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02332681
- Sponsor's protocol ID
- 38151514.8.0000.5404
- Status last verified
- Dec 2014
- First submitted
- 5 Jan 2015
- Last updated
- 7 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kanis JA, McCloskey EV, Johansson H, Cooper C, Rizzoli R, Reginster JY; Scientific Advisory Board of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) and the Committee of Scientific Advisors of the International Osteoporosis Foundation (IOF). European guidance for the diagnosis and management of osteoporosis in postmenopausal women. Osteoporos Int. 2013 Jan;24(1):23-57. doi: 10.1007/s00198-012-2074-y. Epub 2012 Oct 19.
PubMed 23079689Kanis JA, Johnell O, Oden A, Sembo I, Redlund-Johnell I, Dawson A, De Laet C, Jonsson B. Long-term risk of osteoporotic fracture in Malmo. Osteoporos Int. 2000;11(8):669-74. doi: 10.1007/s001980070064.
PubMed 11095169van Staa TP, Dennison EM, Leufkens HG, Cooper C. Epidemiology of fractures in England and Wales. Bone. 2001 Dec;29(6):517-22. doi: 10.1016/s8756-3282(01)00614-7.
PubMed 11728921Bouxsein ML, Kaufman J, Tosi L, Cummings S, Lane J, Johnell O. Recommendations for optimal care of the fragility fracture patient to reduce the risk of future fracture. J Am Acad Orthop Surg. 2004 Nov-Dec;12(6):385-95. doi: 10.5435/00124635-200411000-00003.
PubMed 15615504Friedman SM, Mendelson DA. Fragility fractures. Clin Geriatr Med. 2014 May;30(2):xiii-xiv. doi: 10.1016/j.cger.2014.01.019. Epub 2014 Mar 4. No abstract available.
PubMed 24721376
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteoporosis and Knee Insufficiency Fracture
- ClinicalTrials.gov ID
- NCT02332681
- Acronym / sponsor ID
- 38151514.8.0000.5404
- Conditions
- Osteoporosis, Osteoporotic Fractures, Osteonecrosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- University of Campinas, Brazil
- Study start
- Dec 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 7 Jan 2015 (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.
Osteoporosis is a systemic bone disease characterized by low bone mass and microarchitectural deterioration of bone tissue with consequent bone fragility and susceptibility to fracture. Fifty percent of women and 20% men older than 50 y.o. will have an osteoporotic fracture (fragility fracture). Fragility fracture is defined as one that results from a low-energy trauma such as a fall from body height. A previous fracture is an important predictor of a new fracture, especially in the first 5 years after initial fracture. A second fracture can be particularly devastating if it is a hip fracture. Low bone mineral density, measured by bone densitometry, as well as a previous osteoporotic fracture, are the two major risk factors for the occurrence of a new fracture.
A more rational approach currently used to minimize the costs of health care in a shorter period of time uses the strategy of firstly preventing the occurrence of secondary fracture, followed by primary prevention strategies. In this context, correct identification of fragility fractures and consequent treatment of those individuals is imperative. There are currently insufficient data about the epidemiology and evolution of other fragility fractures, also known as non-vertebral non-hip fracture (NVNH). Among these, distal radius fracture and proximal humerus fractures are the most frequent. There is a type of fracture, however, that is simply ignored by the medical community: the knee insufficiency fracture.A possible explanation for this information gap could be the fact that, until a few years ago, this entity was believed to be a osteonecrosis of the knee. Only recently it is becoming clear that the cause of pain and marrow bone edema that occur subtly in older individuals is, in fact, a insufficiency fracture. The perception that this lesion is actually a fracture is relatively new. The knee insufficiency fracture usually occurs in older individuals and those with knee osteoarthritis. This study therefore aims to evaluate whether there is a relation between knee insufficiency fracture and osteoporosis. Moreover, it is expected to find out if this fracture may be defined as a fragility fracture, electing the individuals affected by it to a prophylaxis for the occurrence of new osteoporotic fracture.
Detailed description
Osteoporosis is a systemic bone disease characterized by low bone mass and microarchitectural deterioration of bone tissue with consequent bone fragility and susceptibility to fractures. Fifty percent of women and 20% of men older than 50 y.o. will have an osteoporotic fracture (fragility fracture). Fragility fracture is defined as one that results from a low-energy trauma such as a fall from body height. A previous fracture is an important predictor of a new fracture, especially in the first 5 years after the initial fracture. A second fracture can be particularly devastating if a hip fracture. Approximately 25% of individuals with hip fracture die in five years and only half of them recover the pre-fracture status, meaning loss of ambulation ability and independence in domestic activities. In addition, fragility fractures generate significant cost to the health system - the annual cost of osteoporotic fractures in patients older than 50 years in the United States is estimated at 1.3 billion dollar.
Low bone mineral density, measured by bone densitometry, as well as a previous osteoporotic fracture, are the two major risk factors for the occurrence of a new fracture. A crucial observation is that fracture attracts fracture, ie, individuals who had a fragility fracture are twice as likely to suffer a second fracture and half of patients with a hip fracture had previously broken another bone. Therefore, a more rational approach currently used to minimize the costs of health care more effectively and in a short time uses firstly the strategy of preventing the occurrence of secondary fracture, followed by primary prevention strategies. In this context, the correct identification of fragility fractures and the consequent treatment of individuals makes it imperative. However, it is surprising and discouraging the information that despite the huge range of currently available treatments, most patients who sustain a fragility fracture does not receive treatment.
Vertebral fractures and hip has undoubtedly the greatest impact on walking ability of the elderly, and great attention is given to these two types of fracture. Consequently, there are currently insufficient data on the epidemiology and evolution of other fragility fractures, also known as non-vertebral non-hip fracture (NVNH). Among these, distal radius and proximal humerus fractures are the most frequent. There is a type of fracture, however, that is simply ignored by the medical community: the knee insufficiency fracture. The fact that no literature study even hypothesize that this type of fracture may be a fragility fracture may be because, until a few years ago, it was believed that this entity was a osteonecrosis of the knee. The knee insufficiency fracture usually occurs in older individuals and those with knee osteoarthritis. This study therefore aims to evaluate whether a relation between the knee insufficiency fracture and osteoporosis. Moreover, it is expected to find out if this fracture may be defined as a fragility fracture, electing the individuals affected by it to a prophylaxis for the occurrence of new osteoporotic fracture.
BACKGROUND
The knee insufficiency fracture usually occurs in older individuals and those with knee osteoarthritis. Currently no literature study even suggests the hypothesis that this type of fracture may be a fragility fracture. A possible explanation for this information gap could be the fact that, until a few years ago, this entity was believed to be a osteonecrosis of the knee. Only recently it is becoming clear that the cause of pain and marrow bone edema that occur subtly in older individuals is, in fact, a insufficiency fracture. This study therefore aims to evaluate whether a relation between the knee insufficiency fracture and osteoporosis. Moreover, it is expected to find out if this fracture may be defined as a fragility fracture, electing the individuals affected by it to a prophylaxis for the occurrence of new osteoporotic fracture.
OBJECTIVES
The objective of this study is to evaluate whether there is a relationship between the knee insufficiency fracture and osteoporosis.
EXPECTED FINDINGS
Patients with knee insufficiency fracture have a higher prevalence of osteoporosis than the general population.
Patients with knee insufficiency fracture have a higher risk of having a second osteoporotic fracture
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With insufficiency fracture | – | –Patients with acute pain that sustained a knee insufficiency fracture |
| Without insufficiency fracture | – | –Patients with acute pain that did not sustained a knee insufficiency fracture |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients older than 45 years, with sudden joint line knee pain without high trauma history, with or without a history of osteoarthritis and / or osteoporosis.
Key inclusion criteria (3 listed)
- patients who seek orthopedics service with sudden onset of pain in the knee;
- age of 45 y.o. or more
- acceptance by signing the informed consent form.
Key exclusion criteria (3 listed)
- acute trauma of knee
- other etiologies (post-traumatic, infectious, inflammatory diseases)
- pregnant women
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
New fracture
Time frame: 12 months
Occurrence of a new fragility fracture
1 secondary outcome
Bone Mineral Density
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2015.
- Results publication: PubMed 23079689Kanis JA, McCloskey EV, Johansson H, Cooper C, Rizzoli R, Reginster JY; Scientific Advisory Board of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) and the Committee of Scientific Advisors of the International Osteoporosis Foundation (IOF). European guidance for the diagnosis and management of osteoporosis in postmenopausal women. Osteoporos Int. 2013 Jan;24(1):23-57. doi: 10.1007/s00198-012-2074-y. Epub 2012 Oct 19.
- Results publication: PubMed 11095169Kanis JA, Johnell O, Oden A, Sembo I, Redlund-Johnell I, Dawson A, De Laet C, Jonsson B. Long-term risk of osteoporotic fracture in Malmo. Osteoporos Int. 2000;11(8):669-74. doi: 10.1007/s001980070064.
- Results publication: PubMed 11728921van Staa TP, Dennison EM, Leufkens HG, Cooper C. Epidemiology of fractures in England and Wales. Bone. 2001 Dec;29(6):517-22. doi: 10.1016/s8756-3282(01)00614-7.
- Results publication: PubMed 15615504Bouxsein ML, Kaufman J, Tosi L, Cummings S, Lane J, Johnell O. Recommendations for optimal care of the fragility fracture patient to reduce the risk of future fracture. J Am Acad Orthop Surg. 2004 Nov-Dec;12(6):385-95. doi: 10.5435/00124635-200411000-00003.
- Results publication: PubMed 24721376Friedman SM, Mendelson DA. Fragility fractures. Clin Geriatr Med. 2014 May;30(2):xiii-xiv. doi: 10.1016/j.cger.2014.01.019. Epub 2014 Mar 4. No abstract available.
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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.
Gustavo C Campos, Phd principal investigator
University of Campinas
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 Osteoporosis and Osteoporotic Fractures, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 3 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 7 Jan 2015. 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 Brazil. 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 Gustavo C Campos, Phd (+551983318000, gustavoccampos@terra.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New fracture (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02332681, which also lists 5 linked publications.
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 7 Jan 2015.