OsteoporosisPhase 3NCT00567294
Evaluating Ways to Improve Medication Use Among People With Osteoporosis
A Phase 3 study testing Mailed education, Telephone coaching program for patients and Medication adherence alert program for doctors in people with Osteoporosis, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Mailed education, Telephone coaching program for patients and Medication adherence alert program for doctors
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,087 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Jan 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- Unable to communicate over the telephone with health educators
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Improving Medication Adherence for Osteoporosis: A Community-Based Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Osteoporosis
- Being tested
- Mailed education, Telephone coaching program for patients, Medication adherence alert program for doctors
- Keywords
- Osteoporosis, Medication adherence, Telephonic education, Motivational interviewing
- Medical subject headings
- Osteoporosis, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mailed educationBehavioural
Mailed education materials on osteoporosis and medication use over a 1-year period
Telephone coaching program for patientsBehavioural
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.
Medication adherence alert program for doctorsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Participants will receive mailed education materials on osteoporosis and medication use. Receives: Behavioral: Mailed education |
| B | Experimental | Participants will receive a telephone coaching program. Receives: Behavioral: Telephone coaching program for patients |
| C | Experimental | Participants will receive a telephone coaching program, and doctors of these participants will receive medication adherence alert notifications. Receives: Behavioral: Telephone coaching program for patients; Behavioral: Medication adherence alert program for doctors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence
Measured: At Month 12
Secondary outcomes (1)
Medication persistence
Measured: At Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2007 (estimated)
- Study startNov 2007
- Primary completionDec 2009
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,087 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Daniel H. Solomon, M.D.,MPH, Brigham and Women's Hospital
- Investigators
- Daniel H. Solomon, MD, MPH, Principal investigator, Brigham and Women's HospitalTimothy Gleeson, BS, Study director, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567294
- Sponsor's protocol ID
- P60AR047782
- Other IDs
- P60AR047782, P60AR047782-06A1
- Status last verified
- May 2012
- First submitted
- 30 Nov 2007
- Last updated
- 15 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1001/archinternmed.2011.1977. Epub 2012 Feb 27.
PubMed 22371876
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Medication Adherence for Osteoporosis: A Community-Based Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00567294
- Acronym / sponsor ID
- P60AR047782
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis, Medication adherence, Telephonic education, Motivational interviewing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,087 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Nov 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 4 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Behavioral: Mailed educationParticipants will receive mailed education materials on osteoporosis and medication use. |
| B | Experimental | Behavioral: Telephone coaching program for patientsParticipants will receive a telephone coaching program. |
| C | Experimental | Behavioral: Telephone coaching program for patients, Behavioral: Medication adherence alert program for doctorsParticipants will receive a telephone coaching program, and doctors of these participants will receive medication adherence alert notifications. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Unable to communicate over the telephone with health educators
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mailed educationMailed education materials on osteoporosis and medication use over a 1-year period | Behavioural | A |
| Telephone coaching program for patientsA 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. | Behavioural | B, C |
| Medication adherence alert program for doctorsDoctors 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. | Behavioural | C |
Primary outcome
Medication adherence
Time frame: At Month 12
1 secondary outcome
Medication persistence
Time frame: At Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2012.
- Results publication: PubMed 22371876Solomon 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. doi: 10.1001/archinternmed.2011.1977. Epub 2012 Feb 27.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel H. Solomon, MD, MPH principal investigator
Brigham and Women's Hospital
Timothy Gleeson, BS study director
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mailed education, Telephone coaching program for patients and Medication adherence alert program for doctors in people with Osteoporosis, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence (time frame: At Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00567294, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2012.