NCT02239523

Brief Summary

Patients who present with fragility fractures are consistently under-evaluated and under-treated for underlying osteoporosis. This point of care represents a lost opportunity to prevent future fractures. The medical field treats the fracture as if the fall is the problem, but bone quality is the real problem. Studies have consistently shown that the recommendations of the International Osteoporosis Foundation and World Health Organization are not being followed. Orthopedics treats the patients for their fractures and primary care physicians focus on general health but no one is taking responsibility for bone health. Strategies to convince primary care to assume care have not succeeded. On the other hand, strategies where orthopedics takes some responsibility have shown success. This prospective 2-arm study will evaluate the success of effort by an academic orthopedic department in osteoporosis evaluation and treatment. We hypothesize that with greater effort by the orthopedic department, the better the adherence to standards of care. A cost benefit analysis will be made in parallel.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

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

September 10, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 12, 2014

Completed
2.4 years until next milestone

Study Start

First participant enrolled

February 21, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

April 5, 2019

Status Verified

September 1, 2018

Enrollment Period

1.9 years

First QC Date

September 10, 2014

Last Update Submit

April 3, 2019

Conditions

Osteoporotic Fracture

Keywords

Pathologic fractureInsufficiency fractureSecondary fractureFracture with bone fragilityOsteoporosisBone lossOsteopeniaMetabolic Bone DiseaseFragility fracture

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients with osteoporosis that are appropriately treated

    Treatment will be determined based on a pre-determined algorithm by our endocrinology department. This will be based on patient factors and results of DEXA is not part of the algorithm. All patients with a fragility fracture of the hip, regardless of DEXA results will be considered for treatment.

    Determination of proper treatment will be made at 4 months after the fracture.

Secondary Outcomes (1)

  • Percentage of patients who undergo DEXA scan.

    Evaluation will be made 4 months after the initial fracture event.

Other Outcomes (1)

  • Cost benefit analysis

    Evaluation will be made at time of discharge and up to 4 months from the fracture event.

Study Arms (2)

Letter Group

ACTIVE COMPARATOR

Patients will be given discharge letter that includes recommendation to discuss further testing and treatment with their primary care physician.

Procedure: Letter Group

Intervention Group

EXPERIMENTAL

Patients will be given a pamphlet about osteoporosis and importance of treatment, have a bone density test (DEXA) arranged, be given a specific medication recommendation and monthly followup phone calls.

Procedure: Intervention Group

Interventions

Letter GroupPROCEDURE

At time of discharge from the hospital, patients will be sent home with a letter that includes standard recommendations for evaluation and treatment for osteoporosis. This will be asked to give the letter to their primary care physician.

Letter Group
Intervention GroupPROCEDURE

The orthopedic department will be responsible for arranging bone density testing (DEXA) and recommending specific medication after discharge. A research assistant will call monthly to encourage treatment.

Also known as: Intervention, Dual-energy X-ray absorptiometry, Bone density scan, Bisphosphonate, Prolia, Denosumab, Forteo, Teriparatide
Intervention Group

Eligibility Criteria

Age50 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients over age 50 with fragility fracture defined as a fall from standing or walking position

You may not qualify if:

  • Patients with metastatic cancer
  • Known metabolic bone disease
  • End-of-life care
  • Inability to provide consent
  • Known MRSA carriers
  • Fractures of the trochanter alone, shaft or peri-prosthetic fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

Related Publications (4)

  • Rozental TD, Makhni EC, Day CS, Bouxsein ML. Improving evaluation and treatment for osteoporosis following distal radial fractures. A prospective randomized intervention. J Bone Joint Surg Am. 2008 May;90(5):953-61. doi: 10.2106/JBJS.G.01121.

    PMID: 18451385BACKGROUND

  • Edwards BJ, Koval K, Bunta AD, Genuario K, Hahr A, Andruszyn L, Williams M. Addressing secondary prevention of osteoporosis in fracture care: follow-up to "own the bone". J Bone Joint Surg Am. 2011 Aug 3;93(15):e87. doi: 10.2106/JBJS.I.00540.

    PMID: 21915530BACKGROUND

  • Gardner MJ, Brophy RH, Demetrakopoulos D, Koob J, Hong R, Rana A, Lin JT, Lane JM. Interventions to improve osteoporosis treatment following hip fracture. A prospective, randomized trial. J Bone Joint Surg Am. 2005 Jan;87(1):3-7. doi: 10.2106/JBJS.D.02289.

    PMID: 15634808BACKGROUND

  • Zinger G, Sylvetsky N, Levy Y, Steinberg K, Bregman A, Yudkevich G, Peyser A. Early benefits of a secondary fracture prevention programme. Hip Int. 2023 Mar;33(2):332-337. doi: 10.1177/11207000211027476. Epub 2021 Jun 27.

    PMID: 34180292DERIVED

MeSH Terms

Conditions

Osteoporotic FracturesFractures, SpontaneousFractures, StressOsteoporosisBone Diseases, Metabolic

Interventions

MethodsAbsorptiometry, PhotonDiphosphonatesDenosumabTeriparatide

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Investigative TechniquesRadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDensitometryPhotometryChemistry Techniques, AnalyticalOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsParathyroid HormonePeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptides

Study Officials

  • Gershon Zinger, MD MS

    Shaare Zedek Medical Center, Jerusalem Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2014

First Posted

September 12, 2014

Study Start

February 21, 2017

Primary Completion

January 17, 2019

Study Completion

February 28, 2019

Last Updated

April 5, 2019

Record last verified: 2018-09

Locations

IL(1)