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GIOP Prevention Among People With Rheumatoid Arthritis

Osteoporosis Prevention Among People With Rheumatoid Arthritis Receiving Oral Glucocorticoid Therapy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00609830
Enrollment
273
Registered
2008-02-07
Start date
2001-07-31
Completion date
2006-02-28
Last updated
2015-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis, Rheumatoid Arthritis

Keywords

Glucocorticoids, Osteoporosis, Rheumatoid Arthritis, Prevention, GIOP, Patient Education

Brief 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. 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.

Interventions

BEHAVIORALTailored Materials

Participants received written educational materials concerning each behavior targeted. The materials were tailored to the participants' stage of change with respect to each behavior.

BEHAVIORALTailored Materials Plus Physician Feedback

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.

BEHAVIORALGeneric Materials

Participants received generic written educational materials about osteoporosis prevention.

BEHAVIORALNo Information

Participants received no informational materials.

Sponsors

University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Existing osteoporosis * Pregnancy * Breast feeding * History of breast cancer * Physician recommendation to limit calcium intake * Class IV rheumatoid arthritis

Design outcomes

Primary

MeasureTime frame
Calcium IntakeOne Year
Vitamin D IntakeOne Year
Bone Mineral Density TestingOne Year
Use of prophylactic medications (e.g., bisphosphonates)One Year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026