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Evaluating Ways to Improve Medication Use Among People With Osteoporosis

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ClinicalTrials.gov Identifier: NCT00567294
Recruitment Status : Completed
First Posted : December 4, 2007
Last Update Posted : May 15, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Osteoporosis Behavioral: Mailed education Behavioral: Telephone coaching program for patients Behavioral: Medication adherence alert program for doctors Phase 3

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.

  • Group A participants will receive mailed education materials on osteoporosis and medication use throughout the 1-year study.
  • Group B participants will receive monthly 5- to 10-minute phone calls from a health educator who is specially trained in osteoporosis. The phone calls will involve coaching participants on behavioral reinforcement strategies that will help them to continue taking their medications on schedule. Participants will also receive specially tailored education on osteoporosis and fracture prevention during the phone calls. A close family member or friend of the participant will be contacted via phone two times during the study year. During these phone calls, the family member or friend will learn how to support the participant in such a way that medication adherence is more likely.
  • Group C participants will receive the same treatment as Group B. Doctors assigned to Group C will receive written educational information on the rates of medication adherence, implications of nonadherence, and methods for improving adherence among patients. Doctors will also receive alerts about any of their participating patients who are not filling medication prescriptions. The alert message will be provided in both paper and electronic format. The electronic format can be easily formatted, allowing the doctor to send a personalized letter to their patients.

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2087 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Medication Adherence for Osteoporosis: A Community-Based Randomized Controlled Trial
Study Start Date : November 2007
Primary Completion Date : December 2009
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: A
Participants will receive mailed education materials on osteoporosis and medication use.
Behavioral: Mailed education
Mailed education materials on osteoporosis and medication use over a 1-year period
Experimental: B
Participants will receive a telephone coaching program.
Behavioral: Telephone coaching program for patients
A telephone coaching program that will involve twelve monthly 5- to 10-minute phone calls from a health educator who is specially trained in osteoporosis. The phone calls will involve coaching participants on behavioral reinforcement strategies that will help them to continue taking their medications on schedule; phone calls will also include specially tailored education on osteoporosis and fracture prevention. A close family member or friend of the participant will also be contacted via phone two times during the study by the health educator. During these phone calls, the family member or friend will learn how to support the participant in such a way that medication adherence is more likely.
Experimental: C
Participants will receive a telephone coaching program, and doctors of these participants will receive medication adherence alert notifications.
Behavioral: Telephone coaching program for patients
A telephone coaching program that will involve twelve monthly 5- to 10-minute phone calls from a health educator who is specially trained in osteoporosis. The phone calls will involve coaching participants on behavioral reinforcement strategies that will help them to continue taking their medications on schedule; phone calls will also include specially tailored education on osteoporosis and fracture prevention. A close family member or friend of the participant will also be contacted via phone two times during the study by the health educator. During these phone calls, the family member or friend will learn how to support the participant in such a way that medication adherence is more likely.
Behavioral: Medication adherence alert program for doctors
Doctors of participants will receive written educational information on the rates of medication adherence, implications of nonadherence, and methods for improving adherence among people with osteoporosis. Doctors will also receive alerts on any patients who are not filling their medication prescriptions.


Outcome Measures

Primary Outcome Measures :
  1. Medication adherence [ Time Frame: At Month 12 ]

Secondary Outcome Measures :
  1. Medication persistence [ Time Frame: At Month 12 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients enrolled in the Pharmaceutical Assistance Contract for the Elderly (PACE) program at the Pennsylvania Department of Aging who begin taking a medication for osteoporosis

Exclusion Criteria:

  • Unable to communicate over the telephone with health educators
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00567294


Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Principal Investigator: Daniel H. Solomon, MD, MPH Brigham and Women's Hospital
Study Director: Timothy Gleeson, BS Brigham and Women's Hospital
More Information

Publications:
Responsible Party: Daniel H. Solomon, M.D.,MPH, Associate Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00567294     History of Changes
Other Study ID Numbers: P60AR047782 ( U.S. NIH Grant/Contract )
P60AR047782-06A1 ( U.S. NIH Grant/Contract )
First Posted: December 4, 2007    Key Record Dates
Last Update Posted: May 15, 2012
Last Verified: May 2012

Keywords provided by Daniel H. Solomon, M.D.,MPH, Brigham and Women's Hospital:
Osteoporosis
Medication adherence
Telephonic education
Motivational interviewing

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases