Trial Outcomes & Findings for Patient Activation After DXA Result Notification (NCT NCT01507662)
NCT ID: NCT01507662
Last Updated: 2020-11-10
Results Overview
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.
COMPLETED
NA
7749 participants
12 weeks after DXA
2020-11-10
Participant Flow
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).
Participant milestones
| Measure |
BMD Result Letter and Brochure
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.
|
Control
Usual care
|
|---|---|---|
|
Overall Study
STARTED
|
3898
|
3851
|
|
Overall Study
COMPLETED
|
3082
|
3020
|
|
Overall Study
NOT COMPLETED
|
816
|
831
|
Reasons for withdrawal
| Measure |
BMD Result Letter and Brochure
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.
|
Control
Usual care
|
|---|---|---|
|
Overall Study
Death
|
26
|
18
|
|
Overall Study
Withdrawal by Subject
|
290
|
287
|
|
Overall Study
Lost to Follow-up
|
498
|
523
|
|
Overall Study
Proxy interview done
|
2
|
3
|
Baseline Characteristics
Patient Activation After DXA Result Notification
Baseline characteristics by cohort
| Measure |
BMD Result Letter and Brochure
n=3898 Participants
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.
|
Control
n=3851 Participants
Usual care
|
Total
n=7749 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.5 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
66.7 years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
66.6 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3259 Participants
n=5 Participants
|
3230 Participants
n=7 Participants
|
6489 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
639 Participants
n=5 Participants
|
621 Participants
n=7 Participants
|
1260 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
74 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3824 Participants
n=5 Participants
|
3774 Participants
n=7 Participants
|
7598 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
37 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
842 Participants
n=5 Participants
|
814 Participants
n=7 Participants
|
1656 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2981 Participants
n=5 Participants
|
2954 Participants
n=7 Participants
|
5935 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
34 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3898 participants
n=5 Participants
|
3851 participants
n=7 Participants
|
7749 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after DXAGuideline 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.
Outcome measures
| Measure |
BMD Result Letter and Brochure
n=3898 Participants
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.
|
Control
n=3851 Participants
Usual care
|
|---|---|---|
|
Guideline Concordant Osteoporosis Therapy
|
2537 Participants
|
2477 Participants
|
Adverse Events
BMD Result Letter and Brochure
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place