Efficacy of Monthly Ibandronate in Women With RA and Reduced Bone Mineral Density Receiving Long-term Steroids
Primary Purpose
Rheumatoid Arthritis, Osteoporosis, Osteopenia
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ibandronate
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Rheumatoid Arthritis focused on measuring Rheumatoid arthritis, Glucocorticoid induced osteoporosis, Vertebral fracture
Eligibility Criteria
Inclusion Criteria:
- Rheumatoid arthritis fulfilling the 1987 ACR criteria
- Women equal and above 18 years, less than 75 years old
- L1-4 T score less than -1.0 and equal or above -3.0 SD measured by DXA (Dual Energy X-ray Absorptiometry)
- Patient must have taken prednisolone 5mg or its equivalent for more than 3 consecutive months within 1 year
- Patient who would be taking glucocorticoids for more than 3 months after enrollment
Exclusion Criteria:
- Patient with vertebral fractures or nonvertebral fractures associated with osteoporosis
- Patient diagnosed with malignancy within 5 years
- Patient with endocrine dysfunction
- RA functional class 4
- Patient who took bisphosphonates within 6 months
- Patient on medication affecting bone mineral metabolism
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ibandronate treatment
Placebo arm
Arm Description
Ibandronate 150mg PO once every 4 weeks
Placebo PO once every 4 weeks
Outcomes
Primary Outcome Measures
Changes in L1-4 bone mineral density compared with baseline
Secondary Outcome Measures
Changes in femur bone mineral density compared with baseline
Changes in L1-4 and femur bone mineral density compared with baseline
Changes in C-telopeptide compared with baseline
Cumulative incidence of vertebral fracture
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01287533
Brief Title
Efficacy of Monthly Ibandronate in Women With RA and Reduced Bone Mineral Density Receiving Long-term Steroids
Official Title
Efficacy of Monthly Ibandronate in Women With Rheumatoid Arthritis and Reduced Bone Mineral Density Receiving Long-term Glucocorticoids
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yeong-Wook Song
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study was to investigate the efficacy of oral monthly ibandronate in the management of glucocorticoid induced osteoporosis in women with rheumatoid arthritis.
Detailed Description
Glucocorticoid therapy is associated with a number of significant side effects, of which bone loss resulting in glucocorticoid-induced osteoporosis and an increase in fracture risk is the most serious. However studies show that many patients treated with glucocorticoids do not receive treatment to prevent bone loss. There exist 5 large randomized controlled clinical trials providing evidence that the bisphosphonates etidronate, alendronate, and risedronate are effective in both the prevention and the treatment of glucocorticoid-induced osteoporosis. Significant increases in BMD with bisphosphonate treatment, most consistently observed in lumbar spine, were seen in patients with many different glucocorticoid-treated disorders; most often RA and polymyalgia rheumatica, and occurred generally irrespective of patient age, sex and menopausal status in women. In addition, statically significant reductions in the absolute risk and relative risk of incident radiographic vertebral fractures were demonstrated after 1 year of treatment with risedronate. A similar significant reduction in the risk of incident radiographic vertebral fractures was seen in alendronate treated patients who completed 2 years of a study of alendronate in the prevention and treatment of glucocorticoid-induced osteoporosis. There exists a data about Ibandronate which reported that intermittent intravenous ibandronate reduced vertebral fracture risk in corticosteroid-induced osteoporosis. However, there is no report about oral monthly ibandronate. Current oral bisphosphonates, which are given either daily or weekly, are associated with stringent, inconvenient dosing schedules. Less frequent dosing may provide great acceptability. The objective of this study was to investigate the efficacy of oral monthly ibandronate in women receiving long-term glucocorticoids.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Osteoporosis, Osteopenia
Keywords
Rheumatoid arthritis, Glucocorticoid induced osteoporosis, Vertebral fracture
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
167 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ibandronate treatment
Arm Type
Experimental
Arm Description
Ibandronate 150mg PO once every 4 weeks
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
Placebo PO once every 4 weeks
Intervention Type
Drug
Intervention Name(s)
Ibandronate
Intervention Description
monthly dosage of ibandronate 150mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
monthly dosage of placebo
Primary Outcome Measure Information:
Title
Changes in L1-4 bone mineral density compared with baseline
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Changes in femur bone mineral density compared with baseline
Time Frame
48 weeks
Title
Changes in L1-4 and femur bone mineral density compared with baseline
Time Frame
24 weeks
Title
Changes in C-telopeptide compared with baseline
Time Frame
24 and 48 weeks
Title
Cumulative incidence of vertebral fracture
Time Frame
48 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Rheumatoid arthritis fulfilling the 1987 ACR criteria
Women equal and above 18 years, less than 75 years old
L1-4 T score less than -1.0 and equal or above -3.0 SD measured by DXA (Dual Energy X-ray Absorptiometry)
Patient must have taken prednisolone 5mg or its equivalent for more than 3 consecutive months within 1 year
Patient who would be taking glucocorticoids for more than 3 months after enrollment
Exclusion Criteria:
Patient with vertebral fractures or nonvertebral fractures associated with osteoporosis
Patient diagnosed with malignancy within 5 years
Patient with endocrine dysfunction
RA functional class 4
Patient who took bisphosphonates within 6 months
Patient on medication affecting bone mineral metabolism
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
28161119
Citation
Shin K, Park SH, Park W, Baek HJ, Lee YJ, Kang SW, Choe JY, Yoo WH, Park YB, Song JS, Lee SG, Yoo B, Yoo DH, Song YW. Monthly Oral Ibandronate Reduces Bone Loss in Korean Women With Rheumatoid Arthritis and Osteopenia Receiving Long-term Glucocorticoids: A 48-week Double-blinded Randomized Placebo-controlled Investigator-initiated Trial. Clin Ther. 2017 Feb;39(2):268-278.e2. doi: 10.1016/j.clinthera.2017.01.008. Epub 2017 Feb 1.
Results Reference
derived
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Efficacy of Monthly Ibandronate in Women With RA and Reduced Bone Mineral Density Receiving Long-term Steroids
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