Atypical Femoral Fractures, Osteoporosis, Prodromal Bone Deterioration
Conditions
Brief summary
The purpose of this protocol is to determine the risk of atypical femoral shaft (thigh bone) fractures after long term fracture prevention therapy with a class of drugs called bisphosphonates, colloquially referred to as Alendronate, risedronate, Ibandronate, and Zoledronate. In addition, the study is designed to find out which patient is most likely to develop this potential life changing complication and why. Finally, the results of this study will help clinicians to better understand the reason and thus tailor patient specific treatments…i.e., the right treatment for the right patient for right duration.
Interventions
OTHER500 without BP treatment
lab tests, X-ray, bone scan or MRI, as needed
OTHER500 with BP treatment
lab tests, X-ray, bone scan or MRI, as needed (90 of these individuals can opt for iliac crest bone biopsy)
Sponsors
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Henry Ford Health System
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* women with a diagnosis of osteopenia or osteoporosis as defined by Bone Mineral density (BMD) * patient treated with BPs for \>5 years * patients treated with non-BP anti-fracture medications such as... * estrogens, raloxifene, calcitonin * treatment naive patients
Exclusion criteria
* all men regardless of BMD result * patients with obvious traumatic AFF * patients with normal BMD (better than -1.0 T-score at spine or proximal hip) * unable to take tetracycline * previous use of teriparatide * known allergies to the following: * tetracycline antibiotics * meperidine * midazolam
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prodromal bone deterioration (PBD) | 5 years | Determine the prevalence of PBD and/or Atypical Femoral Fractures (AFF) in patients with post-menopausal or glucocorticoid related osteoporosis, either treated with bisphosphonate (BP) for more than 2 years or never treated with a BP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnosis of PBD | 5 years | Refine diagnostic criteria for the diagnosis of PBD |
Other
| Measure | Time frame | Description |
|---|---|---|
| Osteocyte lacunae | 5 years | Determine the prevalence of osteocyte lacunae. In BP treated patients with Severely Suppressed Bone Turnover (SSBT), PBD, or AFF, or with none of these complications, determine the prevalence of osteocyte lacunae in osteonal and interstitial iliac cortical bone |
Countries
United States
Outcome results
None listed