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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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.

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 groups in NCT00609830
Study groupRoleWhat they receive
Tailored MaterialsExperimentalNot described
Receives: Behavioral: Tailored Materials
Physician FeedbackExperimentalNot described
Receives: Behavioral: Tailored Materials Plus Physician Feedback
Generic MaterialsActive comparatorNot described
Receives: Behavioral: Generic Materials
Placebo ComparatorPlacebo comparatorParticipants receive no information
Receives: Behavioral: No Information

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Calcium Intake

    Measured: One Year

  2. Vitamin D Intake

    Measured: One Year

  3. Bone Mineral Density Testing

    Measured: One Year

  4. 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.

  1. First posted7 Feb 2008 (estimated)
  2. Study startJul 2001
  3. Study completionFeb 2006

Resources

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)
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

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.

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