Clinical trial: Bisphosphonate Users Radiographic Characteristics of the Hip (BURCH) Study (NCT01360099)

Eligibility criteria:
-  INCLUSION CRITERIA - LONGITUDINAL STUDY GROUP:

          -  For the respective groups, individuals need to be either:

               1. Diagnosis of Osteoporosis or Osteopenia AND have received bisphosphonate therapy
                  for at least 5 years

               2. Diagnosis of Osteoporosis or Osteopenia AND have received bisphosphonate therapy
                  for less than 1 year

               3. Diagnosis of Osteoporosis or Osteopenia AND have received bisphosphonate therapy
                  for 1 to 5 years

               4. No Diagnosis of Osteoporosis or Osteopenia AND have never received bisphosphonate
                  therapy

          -  Inclusion Criteria In Common Will Be:

               1. Age 50 or older

               2. Ambulatory

               3. Living independently

        EXCLUSION CRITERIA - LONGITUDINAL STUDY GROUP:

          -  Exclusion Criteria Will Be:

               1. Inability to provide informed consent

               2. Cognitive Impairment (MCI/dementia)

               3. Current diagnosis of cancer including: breast, prostate, lung, colon, stomach,
                  bladder, uterus, rectum, thyroid, and kidney

               4. Previous bilateral hip fractures

               5. Pregnancy

               6. Small bowel resections

               7. Malabsorption

               8. Paget s Disease of the Bone

               9. Preexisting osteomalacia, active malignancy, prior bone metastasis, osteogenesis
                  imperfecta, fibrous dysplasia, history of kidney failure.

                  INCLUSION CRITERIA - GENETICS STUDY GROUP:

                  For the respective groups, individuals need to be either:

               1. Diagnosis of atypical femur fracture within the past 10 years, regardless of
                  bisphosphonate use.

                  OR

               2. Diagnosis of Osteoporosis or Osteopenia AND have received bisphosphonate therapy
                  for at least 5 years without atypical femur fracture.

          -  Inclusion Criteria In Common Will Be:

               1. Age 45 or older

               2. Ambulatory

               3. Living independently

                  EXCLUSION CRITERIA - GENETICS STUDY GROUP:

          -  Exclusion Criteria will be:

               1. Inability to provide informed consent

               2. Cognitive Impairment (MCI/dementia)

               3. Current diagnosis of cancer including: breast, prostate, lung, colon, stomach,
                  bladder, uterus, rectum, thyroid, and kidney

               4. Pregnancy

               5. Small bowel resections

               6. Malabsorption

               7. Paget s Disease of the Bone

        The following information pertains to individuals in the Longitudinal Group.

        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 participant 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 participants will be sent for
        MRI of bilateral femurs and participant 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 participants 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 being treated with corticosteroids 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, participants 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. Users who have taken the drug for 5 years and more who are
        currently on a drug holiday are eligible (because the drug stays in the bone for so long).
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 50 Years old.


Patient description (medical language): A 55-year-old white woman comes for a routine checkup.  She has no significant medical history and does not use tobacco, alcohol, or illicit drugs.  The patient's only medication is an over-the-counter multivitamin.  Family history is notable for a hip fracture in her mother.  Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis.

Patient description (patient's own words): I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis.

Does the patient match the trial criteria? Entailment