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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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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."
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 500 with BP treatment | patients will undergo lab tests, X-ray, bone scan or MRI, as needed (90 of these individuals can opt for iliac crest bone biopsy) |
| |
| 500 without BP treatment | patients will undergo lab tests, X-ray, bone scan or MRI, as needed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 500 without BP treatment | Other | lab tests, X-ray, bone scan or MRI, as needed |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Prodromal bone deterioration (PBD) | 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 | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnosis of PBD | Refine diagnostic criteria for the diagnosis of PBD | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Osteocyte lacunae | 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 | 5 years |
Inclusion Criteria:
Exclusion Criteria:
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Patients will be found within the Henry Ford Health System Division of Endocrinology, Diabetes, Bone & Mineral Disorders
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| Name | Affiliation | Role |
|---|---|---|
| Sudhaker D. Rao, M.B;B.S. | Henry Ford Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Medical Center, New Center One | Detroit | Michigan | 48202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33434290 | Derived | Farlay D, Rizzo S, Ste-Marie LG, Michou L, Morin SN, Qiu S, Chavassieux P, Chapurlat RD, Rao SD, Brown JP, Boivin G. Duration-Dependent Increase of Human Bone Matrix Mineralization in Long-Term Bisphosphonate Users with Atypical Femur Fracture. J Bone Miner Res. 2021 Jun;36(6):1031-1041. doi: 10.1002/jbmr.4244. Epub 2021 Feb 11. |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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Bone & serum to be retained per institutional guidelines and clinical practice
| 500 with BP treatment |
| Other |
lab tests, X-ray, bone scan or MRI, as needed (90 of these individuals can opt for iliac crest bone biopsy) |
|
| D009750 |
| Nutritional and Metabolic Diseases |