Bisphosphonate Users Radiographic Characteristics of the Hip (BURCH) Study

NCT01360099 | Completed

• 2 other identifiers: 11015611-AR-0156
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Osteoporosis; Bone Diseases, Metabolic; Hip Fractures

Keywords

Atypical Hip Fracture; Biosphosphonates; Subtrochanteric Hip Fracture; Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Difference in prevalence of cortical thickening and beaking between long term users vs. short term or non-users of bisphosphonates.

Secondary Outcomes (2)

• Difference in rates of cortical thickening over three years between long term users vs. short term or nonusers of bisphosphonates.

• Difference in rates of subtrochanteric fractures over three years between long term users vs. short term or nonusers of bisphosphonates.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For the respective groups, individuals need to be either:
• Diagnosis of Osteoporosis or Osteopenia AND have received bisphosphonate therapy for at least 5 years
• Diagnosis of Osteoporosis or Osteopenia AND have received bisphosphonate therapy for less than 1 year
• Diagnosis of Osteoporosis or Osteopenia AND have received bisphosphonate therapy for 1 to 5 years
• No Diagnosis of Osteoporosis or Osteopenia AND have never received bisphosphonate therapy
• Age 50 or older
• Ambulatory
• Living independently

You may not qualify if:

• 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.
• For the respective groups, individuals need to be either:
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• Diagnosis of atypical femur fracture within the past 10 years, regardless of bisphosphonate use.
• Diagnosis of Osteoporosis or Osteopenia AND have received bisphosphonate therapy for at least 5 years without atypical femur fracture.
• Age 45 or older
• Ambulatory

Sponsors & Collaborators

• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): lead

Study Sites (2)

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• 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. doi: 10.1002/jbmr.253.

  PMID: 20842676 BACKGROUND

• 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. doi: 10.1210/jc.2004-0952. Epub 2004 Dec 14.

  PMID: 15598694 BACKGROUND

• 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. doi: 10.1056/NEJMc062268. No abstract available.

  PMID: 17093260 BACKGROUND

• Bhattacharyya T, Jha S, Wang H, Kastner DL, Remmers EF. Hypophosphatasia and the risk of atypical femur fractures: a case-control study. BMC Musculoskelet Disord. 2016 Aug 9;17:332. doi: 10.1186/s12891-016-1191-8.

  PMID: 27507156 DERIVED

MeSH Terms

Conditions

Osteoporosis; Bone Diseases, Metabolic; Hip Fractures

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Michael M Ward, M.D.

  National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2011
• First Posted: May 25, 2011
• Study Start: May 4, 2011
• Study Completion: January 11, 2017
• Last Updated: July 2, 2017

Record last verified: 2017-01-11

Locations

US (2)