OsteoporosisNCT01360099
Bisphosphonate Users Radiographic Characteristics of the Hip (BURCH) Study
An observational study of Osteoporosis and Bone Diseases, Metabolic, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 2 sites in United States.
Trial summary
Background: Osteoporosis is a condition where the bone becomes more brittle and more likely to break as a person ages. The drugs that people take to treat this condition have prevented many common hip fractures. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Bone Diseases, Metabolic, Hip Fractures
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 May 2011to 11 Jan 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For the respective groups, individuals need to be either:
- Diagnosis of Osteoporosis or Osteopenia AND have received bisphosphonate therapy for at least 5 years
- Diagnosis of Osteoporosis or Osteopenia AND have received bisphosphonate therapy for less than 1 year
- Diagnosis of Osteoporosis or Osteopenia AND have received bisphosphonate therapy for 1 to 5 years
- No Diagnosis of Osteoporosis or Osteopenia AND have never received bisphosphonate therapy
- Age 50 or older
Show all 16Show fewer
- Ambulatory
- Living independently
- For the respective groups, individuals need to be either:
- <!-- -->
- Diagnosis of atypical femur fracture within the past 10 years, regardless of bisphosphonate use.
- OR
- Diagnosis of Osteoporosis or Osteopenia AND have received bisphosphonate therapy for at least 5 years without atypical femur fracture.
- Age 45 or older
- Ambulatory
- Living independently
Who cannot join
- Inability to provide informed consent
- Cognitive Impairment (MCI/dementia)
- Current diagnosis of cancer including: breast, prostate, lung, colon, stomach, bladder, uterus, rectum, thyroid, and kidney
- Previous bilateral hip fractures
- Pregnancy
- Small bowel resections
Show all 22Show fewer
- Malabsorption
- Paget s Disease of the Bone
- Preexisting osteomalacia, active malignancy, prior bone metastasis, osteogenesis imperfecta, fibrous dysplasia, history of kidney failure.
- Inability to provide informed consent
- Cognitive Impairment (MCI/dementia)
- Current diagnosis of cancer including: breast, prostate, lung, colon, stomach, bladder, uterus, rectum, thyroid, and kidney
- Pregnancy
- Small bowel resections
- Malabsorption
- Paget s Disease of the Bone
- The following information pertains to individuals in the Longitudinal Group.
- Individuals who currently have thigh pain will not be excluded from this study. As the goal of this study is to correlate medication usage with a radiographic feature, individuals concurrently with thigh pain will still be considered, but we will take note of the duration of medication usage and the start of thigh pain per participant history. Duration of thigh pain prior to fracture will likewise be considered. If a current fracture is found on radiographs or suspicion is high for a fracture, selected participants will be sent for MRI of bilateral femurs and participant will be referred back to their primary provider for additional evaluation and treatment.
- Individuals who have previously had a unilateral hip fracture or arthroplasty will also not be excluded. As several previous studies have shown, bilateral fractures are not uncommon. We will continue to monitor the progress on the contralateral hip. We will query for details regarding history of first fracture and medication usage. These participants will be subanalyzed for medication usage and time between fractures. Individuals with bilateral (but not unilateral) fractures and bilateral arthroplasty initially will be excluded. However, individuals who are found to have unilateral or bilateral fractures during radiographic studies or undergo unilateral or bilateral arthroplasty during their three years of participation will be allowed to remain in the protocol, and we will assess for change in their anatomy.
- Individuals who are being treated with corticosteroids or other types of medications will not be excluded from this study. These variables will be considered confounders and will be analyzed by univariate analysis.
- Individuals with anatomical variations such as coxa vara or coxa valga will not be excluded. We will assume that they will be equally distributed into control and treatment groups. These individuals may be at higher risk for atypical fractures, and will be subanalyzed with appropriate femoral-angle matched controls.
- Controls that choose to begin bisphosphonate during the study will not be excluded from the study, but will be included in a subanalysis of individuals with less than 3 years of bisphosphonate exposure. Likewise, participants who choose to discontinue bisphosphonate usage will also not be dropped from the study. Analysis will be carried through with groups designated by intent to treat. Users who have taken the drug for 5 years and more who are currently on a drug holiday are eligible (because the drug stays in the bone for so long).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Background:
- Osteoporosis is a condition where the bone becomes more brittle and more likely to break as a person ages. The drugs that people take to treat this condition have prevented many common hip fractures. But these drugs may be associated with problems in the shape and structure of the hip bone after many years of use. These changes in the hip bone may lead to an unusual kind of hip fracture. These fractures are very rare, so it is hard to study them. Researchers want to learn more about these fractures.
Read more
Objectives:
- To compare hip x-rays of three groups: people who have been taking osteoporosis drugs for several years, those who have just started taking them, and those who have never taken these drugs.
Eligibility:
- People at least 50 years of age who have been taking osteoporosis drugs for at least 5 years.
- People at least 50 years of age who have been taking these drugs for less than 1 year.
- People at least 50 years of age who have never taken these drugs.
Design:
- All participants will have three total visits over 3 years.
- At the first visit, those taking part will have a medical history and physical exam. They will complete a questionnaire about medication use and bone health. They will also have an x-ray of the hips and pelvis, and have a bone density scan (the kind used to test for osteoporosis) of the hips.
Those in the study will repeat these exams and medical history questions at followup visits. These visits will take place 18 months and 36 months after the first study visit.
- At any of these visits, participants who may have a hip fracture that does not show up on the x-rays will have an imaging study to examine the bone more closely.
- Participants who receive a hip replacement or suffer from a broken bone at any time should inform the study researchers as soon as possible.
Read the detailed description
Objective:
Bisphosphonates are a class of medications that treat osteoporosis and prevent fractures, and have been available for more than a decade. However, there have been recent studies that have shown that, on rare occasions, they may be associated with an atypical hip fracture after long-term use. Radiographic features such as beaking and thickening along the side of the hip bone have been frequently observed with these atypical femur fractures, but most of the studies to date have only been focused on finding the fractures, not the x-ray features. It is not known how common these x-ray features and pain symptoms are amongst bisphosphonate users that have not yet experienced a fracture. If there is a difference between users and non-users, these features may be a valuable finding to help catch fractures before they happen. A recent hypothesis has emerged that a genetic condition, hypophosphatasia, may play a role.
Study population:
This study will evaluate the presence of these features in users of bisphosphonates and the general population. Individuals from the community who have taken bisphosphonates for five or more years (and still taking or have since stopped) will be compared with individuals recently starting bisphosphonate treatment and individuals without osteoporosis and not taking bisphosphonates but similar in age. Another cohort of patients who have sustained atypical femur fractures will also be recruited.
Design:
This study will be look at the frequency of subtrochanteric beaking and cortical thickening between three groups of people: long-term users, short-term users, and non-users. Thorough medication usage history, physical examination of the hip and radiographs (x-rays) will be taken three times over the course of three years, and a one time bone density scan will be performed upon enrolling. We will also perform genetic testing for hypophosphatasia in long term asymptomatic users and patients who have sustained the atypical femur fracture.
Outcome measures:
We will be looking for the presence of these "beaks" and measuring the thickness of the hip bone at a certain spot. We are interested in seeing if there is a difference between our three groups of people at first and also if these two features change over three years. We will also monitor for thigh pain, a feature of impending fracture, and if any fractures are found on x-rays. We will compare the prevalence of hypophosphatasia mutations in asymptomatic bisphosphonate users and subjects who have sustained the atypical femur fracture.
- Conditions
- Osteoporosis, Bone Diseases, Metabolic, Hip Fractures
- Keywords
- Atypical Hip Fracture, Biosphosphonates, Subtrochanteric Hip Fracture, Osteoporosis
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic, Hip Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in prevalence of cortical thickening and beaking between long term users vs. short term or non-users of bisphosphonates.
Secondary outcomes (2)
Difference in rates of cortical thickening over three years between long term users vs. short term or nonusers of bisphosphonates.
Difference in rates of subtrochanteric fractures over three years between long term users vs. short term or nonusers of bisphosphonates.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2011 (estimated)
- Study start4 May 2011
- Study completion11 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies 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
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Michael M Ward, M.D., Principal investigator, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01360099
- Sponsor's protocol ID
- 110156
- Other IDs
- 11-AR-0156
- Status last verified
- 11 Jan 2017
- First submitted
- 20 May 2011
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Shane E, Burr D, Ebeling PR, Abrahamsen B, Adler RA, Brown TD, Cheung AM, Cosman F, Curtis JR, Dell R, Dempster D, Einhorn TA, Genant HK, Geusens P, Klaushofer K, Koval K, Lane JM, McKiernan F, McKinney R, Ng A, Nieves J, O'Keefe R, Papapoulos S, Sen HT, van der Meulen MC, Weinstein RS, Whyte M; American Society for Bone and Mineral Research. Atypical subtrochanteric and diaphyseal femoral fractures: report of a task force of the American Society for Bone and Mineral Research. J Bone Miner Res. 2010 Nov;25(11):2267-94. doi: 10.1002/jbmr.253.
PubMed 20842676Odvina CV, Zerwekh JE, Rao DS, Maalouf N, Gottschalk FA, Pak CY. Severely suppressed bone turnover: a potential complication of alendronate therapy. J Clin Endocrinol Metab. 2005 Mar;90(3):1294-301. doi: 10.1210/jc.2004-0952. Epub 2004 Dec 14.
PubMed 15598694Armamento-Villareal R, Napoli N, Panwar V, Novack D. Suppressed bone turnover during alendronate therapy for high-turnover osteoporosis. N Engl J Med. 2006 Nov 9;355(19):2048-50. doi: 10.1056/NEJMc062268. No abstract available.
PubMed 17093260Bhattacharyya T, Jha S, Wang H, Kastner DL, Remmers EF. Hypophosphatasia and the risk of atypical femur fractures: a case-control study. BMC Musculoskelet Disord. 2016 Aug 9;17:332. doi: 10.1186/s12891-016-1191-8.
PubMed 27507156
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bisphosphonate Users Radiographic Characteristics of the Hip (BURCH) Study
- ClinicalTrials.gov ID
- NCT01360099
- Acronym / sponsor ID
- 110156
- Conditions
- Osteoporosis, Bone Diseases, Metabolic, Hip Fractures
- Keywords
- Atypical Hip Fracture, Biosphosphonates, Subtrochanteric Hip Fracture, Osteoporosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)US National Institutes of Health
- Study start
- 4 May 2011
- Study completion
- 11 Jan 2017
- First posted
- 25 May 2011 (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.
Background:
- Osteoporosis is a condition where the bone becomes more brittle and more likely to break as a person ages. The drugs that people take to treat this condition have prevented many common hip fractures. But these drugs may be associated with problems in the shape and structure of the hip bone after many years of use. These changes in the hip bone may lead to an unusual kind of hip fracture. These fractures are very rare, so it is hard to study them. Researchers want to learn more about these fractures.
Objectives:
- To compare hip x-rays of three groups: people who have been taking osteoporosis drugs for several years, those who have just started taking them, and those who have never taken these drugs.
Eligibility:
- People at least 50 years of age who have been taking osteoporosis drugs for at least 5 years.
- People at least 50 years of age who have been taking these drugs for less than 1 year.
- People at least 50 years of age who have never taken these drugs.
Design:
- All participants will have three total visits over 3 years.
- At the first visit, those taking part will have a medical history and physical exam. They will complete a questionnaire about medication use and bone health. They will also have an x-ray of the hips and pelvis, and have a bone density scan (the kind used to test for osteoporosis) of the hips.
Those in the study will repeat these exams and medical history questions at followup visits. These visits will take place 18 months and 36 months after the first study visit.
- At any of these visits, participants who may have a hip fracture that does not show up on the x-rays will have an imaging study to examine the bone more closely.
- Participants who receive a hip replacement or suffer from a broken bone at any time should inform the study researchers as soon as possible.
Detailed description
Objective:
Bisphosphonates are a class of medications that treat osteoporosis and prevent fractures, and have been available for more than a decade. However, there have been recent studies that have shown that, on rare occasions, they may be associated with an atypical hip fracture after long-term use. Radiographic features such as beaking and thickening along the side of the hip bone have been frequently observed with these atypical femur fractures, but most of the studies to date have only been focused on finding the fractures, not the x-ray features. It is not known how common these x-ray features and pain symptoms are amongst bisphosphonate users that have not yet experienced a fracture. If there is a difference between users and non-users, these features may be a valuable finding to help catch fractures before they happen. A recent hypothesis has emerged that a genetic condition, hypophosphatasia, may play a role.
Study population:
This study will evaluate the presence of these features in users of bisphosphonates and the general population. Individuals from the community who have taken bisphosphonates for five or more years (and still taking or have since stopped) will be compared with individuals recently starting bisphosphonate treatment and individuals without osteoporosis and not taking bisphosphonates but similar in age. Another cohort of patients who have sustained atypical femur fractures will also be recruited.
Design:
This study will be look at the frequency of subtrochanteric beaking and cortical thickening between three groups of people: long-term users, short-term users, and non-users. Thorough medication usage history, physical examination of the hip and radiographs (x-rays) will be taken three times over the course of three years, and a one time bone density scan will be performed upon enrolling. We will also perform genetic testing for hypophosphatasia in long term asymptomatic users and patients who have sustained the atypical femur fracture.
Outcome measures:
We will be looking for the presence of these "beaks" and measuring the thickness of the hip bone at a certain spot. We are interested in seeing if there is a difference between our three groups of people at first and also if these two features change over three years. We will also monitor for thigh pain, a feature of impending fracture, and if any fractures are found on x-rays. We will compare the prevalence of hypophosphatasia mutations in asymptomatic bisphosphonate users and subjects who have sustained the atypical femur fracture.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- For the respective groups, individuals need to be either:
- <!-- -->
- OR
Key exclusion criteria (22 listed)
- The following information pertains to individuals in the Longitudinal Group.
- Individuals who currently have thigh pain will not be excluded from this study. As the goal of this study is to correlate medication usage with a radiographic feature, individuals concurrently with thigh pain will still be considered, but we will take note of the duration of medication usage and the start of thigh pain per participant history. Duration of thigh pain prior to fracture will likewise be considered. If a current fracture is found on radiographs or suspicion is high for a fracture, selected participants will be sent for MRI of bilateral femurs and participant will be referred back to their primary provider for additional evaluation and treatment.
- Individuals who have previously had a unilateral hip fracture or arthroplasty will also not be excluded. As several previous studies have shown, bilateral fractures are not uncommon. We will continue to monitor the progress on the contralateral hip. We will query for details regarding history of first fracture and medication usage. These participants will be subanalyzed for medication usage and time between fractures. Individuals with bilateral (but not unilateral) fractures and bilateral arthroplasty initially will be excluded. However, individuals who are found to have unilateral or bilateral fractures during radiographic studies or undergo unilateral or bilateral arthroplasty during their three years of participation will be allowed to remain in the protocol, and we will assess for change in their anatomy.
- Individuals who are being treated with corticosteroids or other types of medications will not be excluded from this study. These variables will be considered confounders and will be analyzed by univariate analysis.
- Individuals with anatomical variations such as coxa vara or coxa valga will not be excluded. We will assume that they will be equally distributed into control and treatment groups. These individuals may be at higher risk for atypical fractures, and will be subanalyzed with appropriate femoral-angle matched controls.
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
Difference in prevalence of cortical thickening and beaking between long term users vs. short term or non-users of bisphosphonates.
2 secondary outcomes
Difference in rates of cortical thickening over three years between long term users vs. short term or nonusers of bisphosphonates.
Difference in rates of subtrochanteric fractures over three years between long term users vs. short term or nonusers of bisphosphonates.
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 2 Jul 2017.
- Background: PubMed 20842676Shane E, Burr D, Ebeling PR, Abrahamsen B, Adler RA, Brown TD, Cheung AM, Cosman F, Curtis JR, Dell R, Dempster D, Einhorn TA, Genant HK, Geusens P, Klaushofer K, Koval K, Lane JM, McKiernan F, McKinney R, Ng A, Nieves J, O'Keefe R, Papapoulos S, Sen HT, van der Meulen MC, Weinstein RS, Whyte M; American Society for Bone and Mineral Research. Atypical subtrochanteric and diaphyseal femoral fractures: report of a task force of the American Society for Bone and Mineral Research. J Bone Miner Res. 2010 Nov;25(11):2267-94. doi: 10.1002/jbmr.253.
- Background: PubMed 15598694Odvina CV, Zerwekh JE, Rao DS, Maalouf N, Gottschalk FA, Pak CY. Severely suppressed bone turnover: a potential complication of alendronate therapy. J Clin Endocrinol Metab. 2005 Mar;90(3):1294-301. doi: 10.1210/jc.2004-0952. Epub 2004 Dec 14.
- Background: PubMed 17093260Armamento-Villareal R, Napoli N, Panwar V, Novack D. Suppressed bone turnover during alendronate therapy for high-turnover osteoporosis. N Engl J Med. 2006 Nov 9;355(19):2048-50. doi: 10.1056/NEJMc062268. No abstract available.
- Derived from this study: PubMed 27507156Bhattacharyya T, Jha S, Wang H, Kastner DL, Remmers EF. Hypophosphatasia and the risk of atypical femur fractures: a case-control study. BMC Musculoskelet Disord. 2016 Aug 9;17:332. doi: 10.1186/s12891-016-1191-8.
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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.
Michael M Ward, M.D. principal investigator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
2 sites 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 Bone Diseases, Metabolic, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 2 sites in United States.
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 16 inclusion and 22 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 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Difference in prevalence of cortical thickening and beaking between long term users vs. short term or non-users of bisphosphonates.. 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 NCT01360099, which also lists 4 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 2 Jul 2017.