Improving Osteoporosis Care in a Home Health Setting

Osteoporosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01109472
• Other study ID #: X080401004
• Secondary ID: B3D-US-X016
• Status: Completed
• Phase: N/A
• First received: April 21, 2010
• Last updated: December 20, 2013
• Start date: April 2009
• Est. completion date: November 2012

Study information

• Verified date: December 2013
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Study aims to improve osteoporosis care through patient tailored education materials in a group-randomized trial of patients referred to home health care with a history of fracture and/or an osteoporosis diagnosis. Project investigators will conduct telephone surveys and examine electronic medical record data to assess fracture related morbidity and mortality, osteoporosis treatment and adherence, and use of calcium and vitamin D supplements.

We hypothesize that patients that receive the intervention materials will be more likely to initiate or maintain osteoporosis treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1009
• Est. completion date: November 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• prior fracture

• osteoporosis diagnosis

• received home health care

Exclusion Criteria:

• hospice

• active cancer treatment

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Other:
• patient magazine
patient magazine individually tailored to patient's prior feedback

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Alacare Home Health and Hospice, Eli Lilly and Company

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Initiation/Maintenance of Anti-osteoporosis prescription medication		Three months post initial survey	No
Secondary	Initiation/Maintenance of calcium and vitamin D		Three months post initial survey	No