OsteoporosisPhase 1NCT00073190
Patient- and Physician-Based Osteoporosis Education
A Phase 1 study testing Osteoporosis Education in people with Osteoporosis and Osteoporosis, Postmenopausal, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Osteoporosis is an important public health problem. Osteoporosis can cause serious health complications and death and leads to increased medical costs. The purpose of this study is to identify an effective method of educating patients and health care professionals about the diagnosis and treatment of osteoporosis. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Osteoporosis, Postmenopausal
- What is being tested?
- Osteoporosis Education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30,000 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Jun 2006
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- PACE beneficiaries who filled at least one prescription for a drug of any type in the year prior to the study
- At high risk for osteoporosis: women and men 75 years or older, patients taking glucocorticoids or psychoactive medications, patients diagnosed with rheumatoid arthritis, and patients with a past fracture
- Have had an outpatient visit with a participating doctor based on Medicare outpatient claims
- Primary prescribing physicians for PACE beneficiaries
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Daniel H. Solomon MD, MPH
Boston, Massachusetts, 02115
About this study
Official title: Randomized Controlled Testing of Osteoporosis Education
Osteoporosis is an important public health problem. Osteoporosis can cause serious health complications and death and leads to increased medical costs. The purpose of this study is to identify an effective method of educating patients and health care professionals about the diagnosis and treatment of osteoporosis.
Read the detailed description
Osteoporosis affects a large and growing proportion of the population. Multiple drugs for the prevention and treatment of osteoporosis have been developed, tested, and proven effective in the last decade. However, these drugs may not always be adequately prescribed. Several effective nonpharmacological measures also exist for preventing fractures; strength and gait training, home safety modifications, and other lifestyle modifications have all been shown in carefully conducted trails to reduce the risk of falls that lead to osteoporotic fractures. Yet these interventions are under-utilized. Practical public health strategies are needed to bring these experimental findings to widespread use in typical populations of at-risk patients. This study will evaluate innovative fracture prevention interventions targeted to both patients and doctors. Specifically, the study will compare the effects of the patient and physician behavior change intervention alone and in combination on prescribing patterns for osteoporosis therapies and will examine the interventions' effects on fracture prevention behaviors other than medication use.
The patient intervention will consist of two mailings and will be targeted using clinical and demographic data from the State of Pennsylvania's Pharmaceutical Assistance Contract for the Elderly (PACE) and Medicare databases. The first mailing will introduce the topic of osteoporosis and explain why osteoporosis is an important topic for all those receiving the mailing. The second mailing, sent the following month, will reinforce the first mailing and contain patient-specific information based on demographic and clinical factors. This mailing will also focus on several proven prevention strategies, including strength and gait training, vision care, home safety improvements, calcium intake, and pharmaceutical enhancement of bone density.
The physician intervention will be multifaceted and will include a mailed practice audit and one-on-one education through academic detailing. The mail audit will contain information on the physician's PACE patients and an assessment of their osteoporosis risk based on clinical and drug data. Following the mailing, an academic detailer will meet with the physicians receiving the intervention.
Outcome measures will include questionnaires, medication use, Dual Energy X-ray Absorptiometry (DEXA) scans, and use of physical therapy.
- Conditions
- Osteoporosis, Osteoporosis, Postmenopausal
- Being tested
- Osteoporosis Education
- Keywords
- Patient Education, Physician Education
- Medical subject headings
- Osteoporosis, Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteoporosis EducationBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2003 (estimated)
- Study startSep 2003
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 1
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Enrolment
- 30,000 participants
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), Arthritis Foundation
- 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 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00073190
- Sponsor's protocol ID
- K23AR048616
- Other IDs
- K23AR048616, NIAMS-074
- Status last verified
- Dec 2013
- First submitted
- 17 Nov 2003
- Last updated
- 16 Dec 2013
- Results posted
- No
Publications
Solomon DH, Finkelstein JS, Katz JN, Mogun H, Avorn J. Underuse of osteoporosis medications in elderly patients with fractures. Am J Med. 2003 Oct 1;115(5):398-400. doi: 10.1016/s0002-9343(03)00357-7. No abstract available.
PubMed 14553876Solomon DH, Katz JN, La Tourette AM, Coblyn JS. Multifaceted intervention to improve rheumatologists' management of glucocorticoid-induced osteoporosis: a randomized controlled trial. Arthritis Rheum. 2004 Jun 15;51(3):383-7. doi: 10.1002/art.20403.
PubMed 15188323Warsi A, Wang PS, LaValley MP, Avorn J, Solomon DH. Self-management education programs in chronic disease: a systematic review and methodological critique of the literature. Arch Intern Med. 2004 Aug 9-23;164(15):1641-9. doi: 10.1001/archinte.164.15.1641.
PubMed 15302634
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Testing of Osteoporosis Education
- ClinicalTrials.gov ID
- NCT00073190
- Acronym / sponsor ID
- K23AR048616
- Conditions
- Osteoporosis, Osteoporosis, Postmenopausal
- Keywords
- Patient Education, Physician Education
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30,000 participants
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Arthritis Foundation
- Study start
- Sep 2003
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 18 Nov 2003 (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 an important public health problem. Osteoporosis can cause serious health complications and death and leads to increased medical costs. The purpose of this study is to identify an effective method of educating patients and health care professionals about the diagnosis and treatment of osteoporosis.
Detailed description
Osteoporosis affects a large and growing proportion of the population. Multiple drugs for the prevention and treatment of osteoporosis have been developed, tested, and proven effective in the last decade. However, these drugs may not always be adequately prescribed. Several effective nonpharmacological measures also exist for preventing fractures; strength and gait training, home safety modifications, and other lifestyle modifications have all been shown in carefully conducted trails to reduce the risk of falls that lead to osteoporotic fractures. Yet these interventions are under-utilized. Practical public health strategies are needed to bring these experimental findings to widespread use in typical populations of at-risk patients. This study will evaluate innovative fracture prevention interventions targeted to both patients and doctors. Specifically, the study will compare the effects of the patient and physician behavior change intervention alone and in combination on prescribing patterns for osteoporosis therapies and will examine the interventions' effects on fracture prevention behaviors other than medication use.
The patient intervention will consist of two mailings and will be targeted using clinical and demographic data from the State of Pennsylvania's Pharmaceutical Assistance Contract for the Elderly (PACE) and Medicare databases. The first mailing will introduce the topic of osteoporosis and explain why osteoporosis is an important topic for all those receiving the mailing. The second mailing, sent the following month, will reinforce the first mailing and contain patient-specific information based on demographic and clinical factors. This mailing will also focus on several proven prevention strategies, including strength and gait training, vision care, home safety improvements, calcium intake, and pharmaceutical enhancement of bone density.
The physician intervention will be multifaceted and will include a mailed practice audit and one-on-one education through academic detailing. The mail audit will contain information on the physician's PACE patients and an assessment of their osteoporosis risk based on clinical and drug data. Following the mailing, an academic detailer will meet with the physicians receiving the intervention.
Outcome measures will include questionnaires, medication use, Dual Energy X-ray Absorptiometry (DEXA) scans, and use of physical therapy.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- PACE beneficiaries who filled at least one prescription for a drug of any type in the year prior to the study
- At high risk for osteoporosis: women and men 75 years or older, patients taking glucocorticoids or psychoactive medications, patients diagnosed with rheumatoid arthritis, and patients with a past fracture
- Have had an outpatient visit with a participating doctor based on Medicare outpatient claims
- Primary prescribing physicians for PACE beneficiaries
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Osteoporosis Education | Behavioural | – |
Primary outcome
Not reported in the source record.
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 16 Dec 2013.
- Background: PubMed 14553876Solomon DH, Finkelstein JS, Katz JN, Mogun H, Avorn J. Underuse of osteoporosis medications in elderly patients with fractures. Am J Med. 2003 Oct 1;115(5):398-400. doi: 10.1016/s0002-9343(03)00357-7. No abstract available.
- Background: PubMed 15188323Solomon DH, Katz JN, La Tourette AM, Coblyn JS. Multifaceted intervention to improve rheumatologists' management of glucocorticoid-induced osteoporosis: a randomized controlled trial. Arthritis Rheum. 2004 Jun 15;51(3):383-7. doi: 10.1002/art.20403.
- Background: PubMed 15302634Warsi A, Wang PS, LaValley MP, Avorn J, Solomon DH. Self-management education programs in chronic disease: a systematic review and methodological critique of the literature. Arch Intern Med. 2004 Aug 9-23;164(15):1641-9. doi: 10.1001/archinte.164.15.1641.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Osteoporosis Education in people with Osteoporosis and Osteoporosis, Postmenopausal, 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 4 inclusion and 0 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 16 Dec 2013. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00073190, which also lists 3 linked publications.
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 16 Dec 2013.