NIH Clinical Center logo     America's Clinical Research Hospital File folder iconExplore the NIH
Clinical Center
Search the Studies - NIH Clinical Research Studies

Protocol Details

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
Gender: Male & Female
Min Age: 50
Max Age: NA

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Atypical Hip Fracture;
Biosphosphonates;
Subtrochanteric Hip Fracture

Recruitment Keyword(s)

Osteoporosis

Condition(s)

Osteoporosis;
Bone Diseases, Metabolic;
Hip Fractures

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Arthritis and Musculoskeletal and Skin Diseases

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.

--Back to Top--

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.


--Back to Top--

Citations:

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.

Odvina 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. Epub 2004 Dec 14.

Armamento-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.

--Back to Top--

Contacts:

Principal Investigator

Referral Contact

For more information:

Michael M. Ward, M.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
BG 10-CRC RM 4-1339
10 CENTER DR
BETHESDA MD 20814
(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

--Back to Top--

QUESTIONS?

Contact the Patient Recruitment and Public Liaison Office for:

  • Details on how to participate in a study
  • Details on how to refer a patient to a study

NIH Clinical Studies Information Request


Contact the Office of Communications for:

  • General information about the NIH Clinical Center

www.cc.nih.gov/contact.shtml


Contact the Department Clinical Research Informatics, (DCRI) for:

  • Technical questions about Adobe Acrobat and the PDF format
  • Technical questions about this web server

webmaster@cc.nih.gov