Evaluating Ways to Improve Medication Use Among People With Osteoporosis
| Tracking Information | |||||||||
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| First Received Date ICMJE | November 30, 2007 | ||||||||
| Last Updated Date | May 14, 2012 | ||||||||
| Start Date ICMJE | November 2007 | ||||||||
| Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Medication adherence [ Time Frame: At Month 12 ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Medication adherence [ Time Frame: Month 12 ] [ Designated as safety issue: No ] | ||||||||
| Change History | Complete list of historical versions of study NCT00567294 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Medication persistence [ Time Frame: At Month 12 ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
Medication persistence [ Time Frame: Month 12 ] [ Designated as safety issue: No ] | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Evaluating Ways to Improve Medication Use Among People With Osteoporosis | ||||||||
| Official Title ICMJE | Improving Medication Adherence for Osteoporosis: A Community-Based Randomized Controlled Trial | ||||||||
| Brief Summary | Osteoporosis is a common bone disease in older adults in which the bones become weaker and prone to fracture. Medications are available to slow or even stop disease progression. However, very few adults who are prescribed osteoporosis medications actually follow through with filling their prescriptions and taking the medications. Ways to improve medication use have not been well developed or adequately tested. The purpose of this study is to evaluate a telephone coaching program, with or without helpful adherence notifications to doctors, in improving treatment adherence in older adults who are starting an osteoporosis medication. |
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| Detailed Description | Fractures associated with osteoporosis are expected to rise to 3 million by 2025 with a cost of $25 billion in medical costs. Many of these fractures could be avoided through preventive measures, such as improved implementation of fall reduction strategies and use of effective medications. While medications can significantly reduce the chance of fractures among adults with osteoporosis, alarmingly few at-risk adults use osteoporosis treatments regularly. Only 10% to 30% of at-risk adults ever initiate osteoporosis medications, and of those, only 40% to 50% continue to fill their prescriptions after 1 year. There is a clear need to develop ways for improving adherence with osteoporosis medication regimens. The purpose of this study is to evaluate a telephone coaching program, with or without helpful adherence notifications to doctors, in improving treatment adherence in older adults who are starting an osteoporosis medication. Participation in this study will last 1 year. Through random assignment of doctor practices, participants will fall into one of three groups.
At the end of the study, all participants will complete a mailed questionnaire on their behaviors and demographics. Doctors will complete a mailed questionnaire aimed at determining what parts of the interventions were well received. The occurrence of hip, forearm, and/or upper arm fractures will be evaluated using Medicare claims data. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Osteoporosis | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Solomon DH, Iversen MD, Avorn J, Gleeson T, Brookhart MA, Patrick AR, Rekedal L, Shrank WH, Lii J, Losina E, Katz JN. Osteoporosis telephonic intervention to improve medication regimen adherence: a large, pragmatic, randomized controlled trial. Arch Intern Med. 2012 Mar 26;172(6):477-83. Epub 2012 Feb 27. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 2087 | ||||||||
| Completion Date | January 2011 | ||||||||
| Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 65 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00567294 | ||||||||
| Other Study ID Numbers ICMJE | P60 AR047782, P60AR047782, P60 AR047782-06A1 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Daniel H. Solomon, M.D.,MPH, Brigham and Women's Hospital | ||||||||
| Study Sponsor ICMJE | Brigham and Women's Hospital | ||||||||
| Collaborators ICMJE | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||||||
| Investigators ICMJE |
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| Information Provided By | Brigham and Women's Hospital | ||||||||
| Verification Date | May 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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