NCT00609830

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
273

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 7, 2008

Completed
Last Updated

June 16, 2015

Status Verified

January 1, 2008

First QC Date

January 24, 2008

Last Update Submit

June 12, 2015

Conditions

OsteoporosisRheumatoid Arthritis

Keywords

GlucocorticoidsOsteoporosisRheumatoid ArthritisPreventionGIOPPatient Education

Outcome Measures

Primary Outcomes (4)

  • Calcium Intake

    One Year

  • Vitamin D Intake

    One Year

  • Bone Mineral Density Testing

    One Year

  • Use of prophylactic medications (e.g., bisphosphonates)

    One Year

Study Arms (4)

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

Participants receive no information

Behavioral: No Information

Interventions

Tailored MaterialsBEHAVIORAL

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
Tailored Materials Plus Physician FeedbackBEHAVIORAL

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.

Physician Feedback
Generic MaterialsBEHAVIORAL

Participants received generic written educational materials about osteoporosis prevention.

Generic Materials
No InformationBEHAVIORAL

Participants received no informational materials.

Placebo Comparator

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Chapel Hill School of Pharmacy

Chapel Hill, North Carolina, 27599-7360, United States

Location

Related Publications (1)

  • 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.

    PMID: 16208664RESULT

MeSH Terms

Conditions

OsteoporosisArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesArthritisJoint DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Susan J. Blalock, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 24, 2008

First Posted

February 7, 2008

Study Start

July 1, 2001

Study Completion

February 1, 2006

Last Updated

June 16, 2015

Record last verified: 2008-01

Locations

US(1)