Bisphosphonate Users Radiographic Characteristics of the Hip (BURCH) Study
|ClinicalTrials.gov Identifier: NCT01360099|
Recruitment Status : Completed
First Posted : May 25, 2011
Last Update Posted : July 2, 2017
|First Submitted Date||May 20, 2011|
|First Posted Date||May 25, 2011|
|Last Update Posted Date||July 2, 2017|
|Study Start Date||May 4, 2011|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||Difference in prevalence of cortical thickening and beaking between long term users vs. short term or non-users of bisphosphonates.|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT01360099 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Bisphosphonate Users Radiographic Characteristics of the Hip (BURCH) Study|
|Official Title||Bisphosphonate Users Radiographic Characteristics of the Hip (BURCH) Study|
- 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.
- 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.
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.
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.
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.
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.
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|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Original Estimated Enrollment
|Study Completion Date||January 11, 2017|
|Primary Completion Date||Not Provided|
EXCLUSION CRITERIA - LONGITUDINAL STUDY GROUP:
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).
|Ages||50 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||Yes|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||110156
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) )|
|Study Sponsor||National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||January 11, 2017|