N/A
Completed N=2,684
A Direct-to-patient Intervention to Increase Rates of Osteoporosis Care
Source: ClinicalTrials.gov NCT01907269 ↗Enrolled (actual)
2,684
Serious AEs
—
Results posted
Jun 2018
Primary outcomePrimary: Number of Participants That Initiate an Osteoporosis Prescription Medication — 157; 153 Participants
Summary
The purpose of this study is to conduct a randomized trial of a tailored intervention designed to provide personalized feedback regarding patients' risk of subsequent fractures, customized information regarding osteoporosis care, and messaging to activate patients to become more engaged in improving osteoporosis treatment and doctor-patient communication. This novel content will use "story-telling" delivered via the Internet and digital video discs (DVDs). The content will be uniquely tailored to each person based on barriers to care, age and race/ethnicity. We will conduct a controlled, cluster-randomized trial of this intervention to determine differences in post-intervention rates of osteoporosis care between two randomization arms.
We hypothesize that participants randomized to the intervention arm, compared to those randomized to a control arm, will receive more osteoporosis care at 6 months post-intervention, as evidenced by higher rates of: (H1) Prescription osteoporosis therapies, (H2) Non-prescription therapy with calcium and vitamin D, and (H3) Bone mineral density (BMD) testing.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants That Initiate an Osteoporosis Prescription Medication |
136; 131 | — |
| SECONDARY Number of Participants Who Reported Use of Calcium and Vitamin D |
554; 562; 427; 437; 475; 572 | — |
| SECONDARY Number of Participants Who Reported Receipt of Bone Mineral Density (BMD) Testing |
290; 268; 530; 522 | — |
| SECONDARY Number of Participants That Initiate an Osteoporosis Prescription Medication |
136; 131 | — |
Eligibility Criteria
Inclusion Criteria
- Self-reported history of fracture
Exclusion Criteria
- Self-reported current prescription osteoporosis treatment
Data sourced from ClinicalTrials.gov (NCT01907269). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.