MedTrace Logo

Bisphosphonate Users Radiographic Characteristics of the Hip (BURCH) Study

NCT01360099 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2017-07-02

No results posted yet for this study

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

Sponsors & Collaborators

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

    lead NIH

Principal Investigators

  • Michael M Ward, M.D. · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-05-04
Completion
2017-01-11

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01360099 on ClinicalTrials.gov