Pathogenesis of Atypical Femur Fractures on Long Term Bisphosphonate Therapy

Osteoporosis Clinical Trial

— NIH fracture  

Official title:

Pathogenesis of Atypical Femur Fractures on Long Term Bisphosphonate Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02155595
• Other study ID #: 1R01AR062103-01A1
• Status: Completed
• Start date: May 2014
• Est. completion date: August 31, 2018

Study information

• Verified date: March 2019
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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."

Recruitment information / eligibility

• Status: Completed
• Enrollment: 738
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atypical Femoral Fractures
• Femoral Fractures
• Fractures, Bone
• Osteoporosis
• Prodromal Bone Deterioration

Intervention

Other:
• 500 without BP treatment
lab tests, X-ray, bone scan or MRI, as needed
• 500 with BP treatment
lab tests, X-ray, bone scan or MRI, as needed (90 of these individuals can opt for iliac crest bone biopsy)

Locations

Country	Name	City	State
United States	Henry Ford Medical Center, New Center One	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Henry Ford Health System	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Secondary	Diagnosis of PBD	Refine diagnostic criteria for the diagnosis of PBD	5 years