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Patient Activation After DXA Result Notification (PAADRN)

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ClinicalTrials.gov Identifier: NCT01507662
Recruitment Status : Completed
First Posted : January 11, 2012
Results First Posted : April 11, 2017
Last Update Posted : June 29, 2018
Sponsor:
Collaborators:
University of Alabama at Birmingham
Kaiser Permanente
University of Toronto
University of Pittsburgh
Information provided by (Responsible Party):
Fredric D Wolinsky, University of Iowa

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Health Services Research
Conditions Osteoporosis
Bone Diseases, Metabolic
Intervention Behavioral: Bone Mineral Density Result Letter and Bone Health Brochure
Enrollment 7749

Recruitment Details Patients presenting for DXA centers were recruited through February 2012 to August 2014 at three health centers—the University of Iowa (UI), the University of Alabama at Birmingham (UAB), and Kaiser Permanente of Georgia (KPGA).
Pre-assignment Details  
Arm/Group Title BMD Result Letter and Brochure Control
Hide Arm/Group Description

Patients who receive the intervention - BMD result letter with brochure

Bone Mineral Density Result Letter and Bone Health Brochure: Letter mailed to patient to include - Date of DXA, T-score, impression, 10 year major fracture risk with visual depiction of risk, basic bone health guidelines, instructions to follow-up with their healthcare provider. The brochure will include information on osteoporosis, calcium, vitamin D, medicines, exercise, tobacco and alcohol cessation and where to find more information.

Usual care
Period Title: Overall Study
Started 3898 3851
Completed 3082 3020
Not Completed 816 831
Reason Not Completed
Death             26             18
Withdrawal by Subject             290             287
Lost to Follow-up             498             523
Proxy interview done             2             3
Arm/Group Title BMD Result Letter and Brochure Control Total
Hide Arm/Group Description

Patients who receive the intervention - BMD result letter with brochure

Bone Mineral Density Result Letter and Bone Health Brochure: Letter mailed to patient to include - Date of DXA, T-score, impression, 10 year major fracture risk with visual depiction of risk, basic bone health guidelines, instructions to follow-up with their healthcare provider. The brochure will include information on osteoporosis, calcium, vitamin D, medicines, exercise, tobacco and alcohol cessation and where to find more information.

Usual care Total of all reporting groups
Overall Number of Baseline Participants 3898 3851 7749
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3898 participants 3851 participants 7749 participants
66.5  (8.4) 66.7  (8.2) 66.6  (8.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3898 participants 3851 participants 7749 participants
Female
3259
  83.6%
3230
  83.9%
6489
  83.7%
Male
639
  16.4%
621
  16.1%
1260
  16.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3898 participants 3851 participants 7749 participants
Hispanic or Latino
74
   1.9%
77
   2.0%
151
   1.9%
Not Hispanic or Latino
3824
  98.1%
3774
  98.0%
7598
  98.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3898 participants 3851 participants 7749 participants
American Indian or Alaska Native
4
   0.1%
3
   0.1%
7
   0.1%
Asian
37
   0.9%
43
   1.1%
80
   1.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   0.0%
1
   0.0%
Black or African American
842
  21.6%
814
  21.1%
1656
  21.4%
White
2981
  76.5%
2954
  76.7%
5935
  76.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
34
   0.9%
36
   0.9%
70
   0.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3898 participants 3851 participants 7749 participants
3898 3851 7749
1.Primary Outcome
Title Guideline Concordant Osteoporosis Therapy
Hide Description Guideline concordant was defined as those who prescribed a National Osteoporosis Foundation approved osteoporosis therapy for patients with osteoporosis (T-score of femoral neck, hip, or spine ≤−2.5 or FRAX ≥20 %), or patients with a self-reported history of low impact fracture, or patients with osteopenia (T-score between −1.0 and −2.5 at the femoral neck, hips, or lumbar spine) and a 10-year probability of a major osteoporosis-related fracture ≥20 % OR those who were not prescribed a therapy for patients with no self-reported history of prior DXA and study DXA shows normal BMD and no self-reported history of low impact fracture, or study DXA shows osteopenia (T-score of femoral neck, hip, or spine between −1 and −2.5) and FRAX <20 %) and no self-reported history of low impact fracture, or self-reported prior DXA but no self-reported history of low impact fracture and no self-reported history of osteoporosis.
Time Frame 12 weeks after DXA
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BMD Result Letter and Brochure Control
Hide Arm/Group Description:

Patients who receive the intervention - BMD result letter with brochure

Bone Mineral Density Result Letter and Bone Health Brochure: Letter mailed to patient to include - Date of DXA, T-score, impression, 10 year major fracture risk with visual depiction of risk, basic bone health guidelines, instructions to follow-up with their healthcare provider. The brochure will include information on osteoporosis, calcium, vitamin D, medicines, exercise, tobacco and alcohol cessation and where to find more information.

Usual care
Overall Number of Participants Analyzed 3898 3851
Measure Type: Count of Participants
Unit of Measure: Participants
2537
  65.1%
2477
  64.3%
Time Frame Due to the minimal risk nature of our study we did not collect adverse event data. We did track people for one year after enrollment.
Adverse Event Reporting Description Due to the minimal risk nature of our study we did not collect adverse event data.
 
Arm/Group Title BMD Result Letter and Brochure Control
Hide Arm/Group Description

Patients who receive the intervention - BMD result letter with brochure

Bone Mineral Density Result Letter and Bone Health Brochure: Letter mailed to patient to include - Date of DXA, T-score, impression, 10 year major fracture risk with visual depiction of risk, basic bone health guidelines, instructions to follow-up with their healthcare provider. The brochure will include information on osteoporosis, calcium, vitamin D, medicines, exercise, tobacco and alcohol cessation and where to find more information.

Usual care
All-Cause Mortality
BMD Result Letter and Brochure Control
Affected / at Risk (%) Affected / at Risk (%)
Total   26/3898 (0.67%)   18/3851 (0.47%) 
Show Serious Adverse Events Hide Serious Adverse Events
BMD Result Letter and Brochure Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
BMD Result Letter and Brochure Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Fredric Wolinsky
Organization: University of Iowa
Phone: (319) 384-3821
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fredric D Wolinsky, University of Iowa
ClinicalTrials.gov Identifier: NCT01507662     History of Changes
Other Study ID Numbers: 201107758
First Submitted: December 8, 2011
First Posted: January 11, 2012
Results First Submitted: February 24, 2017
Results First Posted: April 11, 2017
Last Update Posted: June 29, 2018