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Bisphosphonate Users Radiographic Characteristics of the Hip (BURCH) Study
This study is currently recruiting participants.
Summary | Eligibility | Citations | Contacts
Summary
Number |
11-AR-0156 |
Sponsoring Institute |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
Recruitment Detail |
Type: Participants currently recruited/enrolled |
Referral Letter Required |
No |
Population Exclusion(s) |
Children |
Special Instructions |
Currently Not Provided |
Keywords |
Atypical Hip Fracture; |
Recruitment Keyword(s) |
Osteoporosis |
Condition(s) |
Osteoporosis; |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
|
- 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.
Eligibility
INCLUSION CRITERIA:
-Age 50 or older
-Ambulatory
-Living independently
EXCLUSION CRITERIA:
-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
-Malabsorption
-Paget's Disease of the Bone
-Preexisting osteomalacia, active malignancy, prior bone metastasis, osteogenesis imperfecta, fibrous dysplasia, history of kidney failure.
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 patient 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 patients will be sent for MRI of bilateral femurs and patient 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 patients 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 on steroids 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, patients 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.
Citations:
Contacts:
Principal Investigator |
Referral Contact |
For more information: |
| Michael M. Ward, M.D. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) National Institutes of Health 10 CENTER DRIVE BG 10 CRC RM 4-1339 MSC 1468 BETHESDA MD 20892-1468 (301) 496-7263 wardm1@mail.nih.gov |
Mildred Wilson, R.N. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) National Institutes of Health Building 10 Room 6N216 10 Center Drive Bethesda, Maryland 20892 (301) 402-4884 wilson1@mail.nih.gov |
Patient Recruitment and Public Liaison Office Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 prpl@mail.cc.nih.gov |
Clinical Trials Number:
NCT01360099
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