NCT01123421

Brief Summary

Study to demonstrate that the Bone UltraSonic Scanner (BUSS) can aid in detection of osteoporosis and predict prevalent osteoporotic fractures. Measurements derived from the BUSS parameters will be able to discriminate between postmenopausal women with osteoporotic fractures when compared to matched controls without history of osteoporotic fracture.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
113

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2010

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

Study Start

First participant enrolled

May 1, 2010

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 14, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

October 15, 2012

Status Verified

October 1, 2012

Enrollment Period

11 months

First QC Date

May 12, 2010

Last Update Submit

October 11, 2012

Conditions

OsteoporosisFractureAging

Keywords

osteoporosisfracture riskagingtibiasonometerultrasoundBMDbone mineral densityDXA3D-HRpQTwaveform profiles

Outcome Measures

Primary Outcomes (1)

  • Determine whether BUSS testing is equivalent or superior to DXA for fracture risk assessment in postmenopausal women.

    1 year

Study Arms (2)

With osteoporotic fracture

Approximately 100 postmenopausal women that have been enrolled in a population-based case-control study that have experienced a clinically-diagnosed fracture of thoracolumbar spine or distal forearm due to minimal or moderate trauma based on review on their inpatient and outpatient medical records will be enrolled.

Without osteoporotic fracture

Approximately 100 control women will have no history of a prior spine, hip, or wrist fracture.

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Both groups

You may qualify if:

  • postmenopausal women with osteoporotic fracture at spine or wrist
  • postmenopausal women no history of fracture at spine or wrist

You may not qualify if:

  • women with a history of metabolic disease
  • stroke
  • tibia fracture or surgery
  • BMI ≥ 35 kg/m2
  • Teriparatide use currently or within the past 6 months,
  • Any skin issues (open wounds or rashes, and/or skin infections) of the tibial area.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

OsteoporosisFractures, Bone

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesWounds and Injuries

Study Officials

  • Armen Sarvazyan, Ph.D., D.Sc.

    Artann Laboratories, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2010

First Posted

May 14, 2010

Study Start

May 1, 2010

Primary Completion

April 1, 2011

Study Completion

February 1, 2012

Last Updated

October 15, 2012

Record last verified: 2012-10

Locations

US(1)