NCT01360099

Bisphosphonate Users Radiographic Characteristics of the Hip (BURCH) Study

Completed Last updated 2 July 2017

What this trial tests

trial in Osteoporosis in 120 participants. Completed in 11 January 2017.

Timeline

4 May 2011

11 January 2017

Quick facts

Lead sponsor	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	120
Start date	4 May 2011
Estimated completion	11 January 2017
Sites	2 locations across United States

Conditions studied

• Osteoporosis — all drugs for Osteoporosis →
• Bone Diseases, Metabolic — all drugs for Bone Diseases, Metabolic →
• Hip Fractures — all drugs for Hip Fractures →

Sponsor

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

Who can join

50 and older, any sex, with Osteoporosis or Bone Diseases, Metabolic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Hypophosphatasia and the risk of atypical femur fractures: a case-control study.
   Bhattacharyya T, Jha S, Wang H, Kastner DL, et al · · 2016 · cited 19× · PMID 27507156 · DOI 10.1186/s12891-016-1191-8