Bisphosphonate Users Radiographic Characteristics of the Hip (BURCH) Study
| Status: | Completed |
|---|---|
| Conditions: | Osteoporosis, Orthopedic, Endocrine, Gastrointestinal |
| Therapuetic Areas: | Endocrinology, Gastroenterology, Rheumatology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 4/22/2017 |
| Start Date: | May 4, 2011 |
| End Date: | January 11, 2017 |
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.
- 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.
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.
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.
- INCLUSION CRITERIA - LONGITUDINAL STUDY GROUP:
- For the respective groups, individuals need to be either:
1. Diagnosis of Osteoporosis or Osteopenia AND have received bisphosphonate therapy
for at least 5 years
2. Diagnosis of Osteoporosis or Osteopenia AND have received bisphosphonate therapy
for less than 1 year
3. Diagnosis of Osteoporosis or Osteopenia AND have received bisphosphonate therapy
for 1 to 5 years
4. No Diagnosis of Osteoporosis or Osteopenia AND have never received
bisphosphonate therapy
- Inclusion Criteria In Common Will Be:
1. Age 50 or older
2. Ambulatory
3. Living independently
EXCLUSION CRITERIA - LONGITUDINAL STUDY GROUP:
- Exclusion Criteria Will Be:
1. Inability to provide informed consent
2. Cognitive Impairment (MCI/dementia)
3. Current diagnosis of cancer including: breast, prostate, lung, colon, stomach,
bladder, uterus, rectum, thyroid, and kidney
4. Previous bilateral hip fractures
5. Pregnancy
6. Small bowel resections
7. Malabsorption
8. Paget s Disease of the Bone
9. Preexisting osteomalacia, active malignancy, prior bone metastasis, osteogenesis
imperfecta, fibrous dysplasia, history of kidney failure.
INCLUSION CRITERIA - GENETICS STUDY GROUP:
For the respective groups, individuals need to be either:
1. Diagnosis of atypical femur fracture within the past 10 years, regardless of
bisphosphonate use.
OR
2. Diagnosis of Osteoporosis or Osteopenia AND have received bisphosphonate therapy
for at least 5 years without atypical femur fracture.
- Inclusion Criteria In Common Will Be:
1. Age 45 or older
2. Ambulatory
3. Living independently
EXCLUSION CRITERIA - GENETICS STUDY GROUP:
- Exclusion Criteria will be:
1. Inability to provide informed consent
2. Cognitive Impairment (MCI/dementia)
3. Current diagnosis of cancer including: breast, prostate, lung, colon, stomach,
bladder, uterus, rectum, thyroid, and kidney
4. Pregnancy
5. Small bowel resections
6. Malabsorption
7. 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).
We found this trial at
2
sites
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9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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