NCT02155595

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."

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
738

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 4, 2014

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

March 29, 2019

Status Verified

March 1, 2019

Enrollment Period

4.3 years

First QC Date

January 29, 2014

Last Update Submit

March 28, 2019

Conditions

OsteoporosisAtypical Femoral FracturesProdromal Bone Deterioration

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Diagnosis of PBD

    5 years

Other Outcomes (1)

  • Osteocyte lacunae

    5 years

Study Arms (2)

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)

Other: 500 with BP treatment

500 without BP treatment

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

Other: 500 without BP treatment

Interventions

500 without BP treatmentOTHER

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

500 without BP treatment
500 with BP treatmentOTHER

lab tests, X-ray, bone scan or MRI, as needed (90 of these individuals can opt for iliac crest bone biopsy)

500 with BP treatment

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients will be found within the Henry Ford Health System Division of Endocrinology, Diabetes, Bone \& Mineral Disorders

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Medical Center, New Center One

Detroit, Michigan, 48202, United States

Location

Related Publications (1)

  • 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.

    PMID: 33434290DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bone \& serum to be retained per institutional guidelines and clinical practice

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Sudhaker D. Rao, M.B;B.S.

    Henry Ford Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior staff physician

Study Record Dates

First Submitted

January 29, 2014

First Posted

June 4, 2014

Study Start

May 1, 2014

Primary Completion

August 31, 2018

Study Completion

August 31, 2018

Last Updated

March 29, 2019

Record last verified: 2019-03

Locations

US(1)