Osteoporosis Clinical Trial
Official title:
Bisphosphonate Users Radiographic Characteristics of the Hip (BURCH) 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.
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.
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