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Completed

NCT Number: NCT02155595

Pathogenesis of Atypical Femur Fractures on Long Term Bisphosphonate Therapy

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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Key information

Conditions

Osteoporosis Atypical Femoral Fractures Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Prodromal Bone Deterioration

Age range

50 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Henry Ford Medical Center, New Center One

Detroit, Michigan, 48202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

500 without BP treatment

Other

lab tests, X-ray, bone scan or MRI, as needed

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)

Primary outcomes

  1. Prodromal bone deterioration (PBD)

    Time frame: 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 outcomes

  1. Diagnosis of PBD

    Time frame: 5 years

    Refine diagnostic criteria for the diagnosis of PBD

Other outcomes

  1. Osteocyte lacunae

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Collaborators

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

Registry information

Acronym: NIH fracture

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jun 4, 2014
Registry last updated
Mar 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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