OsteoporosisNCT00609830
GIOP Prevention Among People With Rheumatoid Arthritis
A study testing Tailored Materials, Tailored Materials Plus Physician Feedback and Generic Materials in people with Osteoporosis and Rheumatoid Arthritis, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The ultimate objective of the proposed research is to improve the health-related quality of life of individuals with rheumatoid arthritis by reducing their risk of developing osteoporosis secondary to glucocorticoid therapy. The study has four specific aims. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoporosis, Rheumatoid Arthritis
- What is being tested?
- Tailored Materials, Tailored Materials Plus Physician Feedback and Generic Materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 273 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2001to Feb 2006
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet American College of Rheumatology criteria for rheumatoid arthritis
- Taking an oral glucocorticoid equivalent to 5 mg/day of prednisone for at least one month prior to study entry
- Age 18 or older
Who cannot join
- Existing osteoporosis
- Pregnancy
- Breast feeding
- History of breast cancer
- Physician recommendation to limit calcium intake
- Class IV rheumatoid arthritis
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill School of Pharmacy
Chapel Hill, North Carolina, 27599-7360
About this study
Official title: Osteoporosis Prevention Among People With Rheumatoid Arthritis Receiving Oral Glucocorticoid Therapy
The ultimate objective of the proposed research is to improve the health-related quality of life of individuals with rheumatoid arthritis by reducing their risk of developing osteoporosis secondary to glucocorticoid therapy. The study has four specific aims.
Specific Aim 1: To obtain descriptive information concerning patients' knowledge, beliefs and behaviors with respect to osteoporosis and osteoporosis prevention.
Read more
Specific Aim 2: To identify factors that discriminate among patients in different stages of change with respect to each behavior of interest.
Specific Aim 3: To compare the effects of tailored versus generic educational materials on patient adherence to the ACR Guidelines for the Prevention of Glucocorticoid-Induced Osteoporosis.
Specific Aim 4: To determine if the effects of tailored educational materials are enhanced by concurrent feedback of information concerning patients' behavioral risk factor status to their physicians.
Read the detailed description
Therapy with oral glucocorticoids often plays an important role in the management of rheumatoid arthritis (RA). The American College of Rheumatology (ACR) Ad Hoc Committee on Clinical Guidelines recently concluded that glucocorticoids are highly effective in relieving symptoms among people with active RA and that these medications may retard the rate of joint damage. Despite these obvious benefits, therapy with oral glucocorticoids is a well-established risk factor for osteoporosis, as highlighted by the recently published ACR Guidelines on the Prevention of Glucocorticoid-induced Osteoporosis. The ultimate objective of the proposed research is to improve the health-related quality of life of individuals with RA by reducing their risk of developing osteoporosis secondary to glucocorticoid therapy. The study has four specific aims: (1) to obtain descriptive information concerning patients' knowledge, beliefs and behaviors with respect to osteoporosis and osteoporosis prevention; (2) to identify factors that discriminate among patients in different stages of change with respect to each behavior of interest; (3) to compare the effects of tailored versus generic educational materials on patient adherence to the ACR Guidelines for the Prevention Glucocorticoid-induced Osteoporosis; and (4) to determine if the effects of tailored educational materials is enhanced by concurrent feedback of information concerning patients' behavioral risk factor status to their physicians. A sample of 273 patients with RA currently taking an oral glucocorticoid were recruited to participate in the study. Data were collected via mailed questionnaires and telephone interviews. The study used an experimental research design. Following baseline data collection, participants were randomly assigned to one of four experimental groups. Patients in one group received standard care only. Patients in the second group received generic educational materials about osteoporosis and osteoporosis prevention in addition to standard care. Patients in the third group received educational materials tailored to their stage in the behavior change process in addition to standard care. Finally, patients in the fourth group received the same tailored educational materials and care received by patients in the third group. In addition, each patient's physician received feedback concerning the patient's status with respect to behavioral risk factors for osteoporosis (e.g., inadequate calcium intake). Follow-up data were collected one year after baseline data collection. Variables assessed included: (1) behavior, (2) stage of change, (3) knowledge and counseling received concerning osteoporosis, (4) health beliefs, (5) physical health status, (6) osteoporosis risk factors, (7) background characteristics, and (8) information seeking. To accomplish the specific aims of the study, data will be analyzed using descriptive statistics, multivariate analysis of variance, and discriminant analyses.
- Conditions
- Osteoporosis, Rheumatoid Arthritis
- Being tested
- Tailored Materials, Tailored Materials Plus Physician Feedback, Generic Materials, No Information
- Keywords
- Glucocorticoids, Osteoporosis, Rheumatoid Arthritis, Prevention, GIOP, Patient Education
- Medical subject headings
- Osteoporosis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored MaterialsBehavioural
Participants received written educational materials concerning each behavior targeted. The materials were tailored to the participants' stage of change with respect to each behavior.
Tailored Materials Plus Physician FeedbackBehavioural
Participants received written educational materials concerning each behavior targeted. The materials were tailored to the participant's stage of change with respect to each behavior. In additon, the participant's physician received information concerning the participant's status on each behavior targeted.
Generic MaterialsBehavioural
Participants received generic written educational materials about osteoporosis prevention.
No InformationBehavioural
Participants received no informational materials.
| Study group | Role | What they receive |
|---|---|---|
| Tailored Materials | Experimental | Not described Receives: Behavioral: Tailored Materials |
| Physician Feedback | Experimental | Not described Receives: Behavioral: Tailored Materials Plus Physician Feedback |
| Generic Materials | Active comparator | Not described Receives: Behavioral: Generic Materials |
| Placebo Comparator | Placebo comparator | Participants receive no information Receives: Behavioral: No Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calcium Intake
Measured: One Year
Vitamin D Intake
Measured: One Year
Bone Mineral Density Testing
Measured: One Year
Use of prophylactic medications (e.g., bisphosphonates)
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study startJul 2001
- Study completionFeb 2006
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 University of North Carolina, Chapel HillThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Investigators
- Susan J. Blalock, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00609830
- Sponsor's protocol ID
- Arthritis Foundation
- Status last verified
- Jan 2008
- First submitted
- 24 Jan 2008
- Last updated
- 16 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Blalock SJ, Norton LL, Patel RA, Dooley MA. Patient knowledge, beliefs, and behavior concerning the prevention and treatment of glucocorticoid-induced osteoporosis. Arthritis Rheum. 2005 Oct 15;53(5):732-9. doi: 10.1002/art.21446.
PubMed 16208664
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteoporosis Prevention Among People With Rheumatoid Arthritis Receiving Oral Glucocorticoid Therapy
- ClinicalTrials.gov ID
- NCT00609830
- Acronym / sponsor ID
- Arthritis Foundation
- Conditions
- Osteoporosis, Rheumatoid Arthritis
- Keywords
- Glucocorticoids, Osteoporosis, Rheumatoid Arthritis, Prevention, GIOP, Patient Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Jul 2001
- Study completion
- Feb 2006 (actual)
- First posted
- 7 Feb 2008 (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.
The ultimate objective of the proposed research is to improve the health-related quality of life of individuals with rheumatoid arthritis by reducing their risk of developing osteoporosis secondary to glucocorticoid therapy. The study has four specific aims.
Specific Aim 1: To obtain descriptive information concerning patients' knowledge, beliefs and behaviors with respect to osteoporosis and osteoporosis prevention.
Specific Aim 2: To identify factors that discriminate among patients in different stages of change with respect to each behavior of interest.
Specific Aim 3: To compare the effects of tailored versus generic educational materials on patient adherence to the ACR Guidelines for the Prevention of Glucocorticoid-Induced Osteoporosis.
Specific Aim 4: To determine if the effects of tailored educational materials are enhanced by concurrent feedback of information concerning patients' behavioral risk factor status to their physicians.
Detailed description
Therapy with oral glucocorticoids often plays an important role in the management of rheumatoid arthritis (RA). The American College of Rheumatology (ACR) Ad Hoc Committee on Clinical Guidelines recently concluded that glucocorticoids are highly effective in relieving symptoms among people with active RA and that these medications may retard the rate of joint damage. Despite these obvious benefits, therapy with oral glucocorticoids is a well-established risk factor for osteoporosis, as highlighted by the recently published ACR Guidelines on the Prevention of Glucocorticoid-induced Osteoporosis. The ultimate objective of the proposed research is to improve the health-related quality of life of individuals with RA by reducing their risk of developing osteoporosis secondary to glucocorticoid therapy. The study has four specific aims: (1) to obtain descriptive information concerning patients' knowledge, beliefs and behaviors with respect to osteoporosis and osteoporosis prevention; (2) to identify factors that discriminate among patients in different stages of change with respect to each behavior of interest; (3) to compare the effects of tailored versus generic educational materials on patient adherence to the ACR Guidelines for the Prevention Glucocorticoid-induced Osteoporosis; and (4) to determine if the effects of tailored educational materials is enhanced by concurrent feedback of information concerning patients' behavioral risk factor status to their physicians. A sample of 273 patients with RA currently taking an oral glucocorticoid were recruited to participate in the study. Data were collected via mailed questionnaires and telephone interviews. The study used an experimental research design. Following baseline data collection, participants were randomly assigned to one of four experimental groups. Patients in one group received standard care only. Patients in the second group received generic educational materials about osteoporosis and osteoporosis prevention in addition to standard care. Patients in the third group received educational materials tailored to their stage in the behavior change process in addition to standard care. Finally, patients in the fourth group received the same tailored educational materials and care received by patients in the third group. In addition, each patient's physician received feedback concerning the patient's status with respect to behavioral risk factors for osteoporosis (e.g., inadequate calcium intake). Follow-up data were collected one year after baseline data collection. Variables assessed included: (1) behavior, (2) stage of change, (3) knowledge and counseling received concerning osteoporosis, (4) health beliefs, (5) physical health status, (6) osteoporosis risk factors, (7) background characteristics, and (8) information seeking. To accomplish the specific aims of the study, data will be analyzed using descriptive statistics, multivariate analysis of variance, and discriminant analyses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tailored Materials | Experimental | Behavioral: Tailored Materials |
| Physician Feedback | Experimental | Behavioral: Tailored Materials Plus Physician Feedback |
| Generic Materials | Active comparator | Behavioral: Generic Materials |
| Placebo Comparator | Placebo comparator | Behavioral: No InformationParticipants receive no information |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Meet American College of Rheumatology criteria for rheumatoid arthritis
- Taking an oral glucocorticoid equivalent to 5 mg/day of prednisone for at least one month prior to study entry
- Age 18 or older
Key exclusion criteria (6 listed)
- Existing osteoporosis
- Pregnancy
- Breast feeding
- History of breast cancer
- Physician recommendation to limit calcium intake
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 |
|---|---|---|
| Tailored MaterialsParticipants received written educational materials concerning each behavior targeted. The materials were tailored to the participants' stage of change with respect to each behavior. | Behavioural | Tailored Materials |
| Tailored Materials Plus Physician FeedbackParticipants received written educational materials concerning each behavior targeted. The materials were tailored to the participant's stage of change with respect to each behavior. In additon, the participant's physician received information concerning the participant's status on each behavior targeted. | Behavioural | Physician Feedback |
| Generic MaterialsParticipants received generic written educational materials about osteoporosis prevention. | Behavioural | Generic Materials |
| No InformationParticipants received no informational materials. | Behavioural | Placebo Comparator |
Primary outcome
Calcium Intake
Time frame: One Year
Vitamin D Intake
Time frame: One Year
Bone Mineral Density Testing
Time frame: One Year
Use of prophylactic medications (e.g., bisphosphonates)
Time frame: One Year
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 Jun 2015.
- Results publication: PubMed 16208664Blalock SJ, Norton LL, Patel RA, Dooley MA. Patient knowledge, beliefs, and behavior concerning the prevention and treatment of glucocorticoid-induced osteoporosis. Arthritis Rheum. 2005 Oct 15;53(5):732-9. doi: 10.1002/art.21446.
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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.
Susan J. Blalock, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored Materials, Tailored Materials Plus Physician Feedback and Generic Materials in people with Osteoporosis and Rheumatoid Arthritis, run by University of North Carolina, Chapel Hill 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 3 inclusion and 6 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 Jun 2015. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Calcium Intake (time frame: One Year). The study lists 4 primary outcomes in all. 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 NCT00609830, 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 16 Jun 2015.