ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: L13

Monthly Ibandronate Reduces Bone Loss in Osteopenic Women with Rheumatoid Arthritis Receiving Long-Term Glucocorticoids: A 48-Week Double-Blinded Randomized Placebo-Controlled Investigator-Initiated Trial

Kichul Shin1, Sung-Hwan Park2, Won Park3, Han Joo Baek4, Yun Jong Lee5, Seong-Wook Kang6, Jung-Yoon Choe7, Wan-Hee Yoo8, Yong-Beom Park9, Jung-Soo Song10, Bin Yoo11, Dae-Hyun Yoo12 and Yeong Wook Song13, 1Rheumatology, SMG-SNU Boramae Medical Center, Seoul, South Korea, 2Division of Rheumatology, Department of Internal Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea, 3Medicine/Rheumatology, Inha University Hospital, Incheon, South Korea, 4Division of Rheumatology, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, South Korea, 5Division of Rheumatology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea, 6Department of Internal Medicine, Chungnam National University School of Medicine, Daejeon, South Korea, 7Division of Rheumatology, Catholic University of Daegu School of Medicine, Daegu, South Korea, 8Department of Internal Medicine, Chonbuk National University Medical School and Research Institute of Clinical Medicine, Jeonju, South Korea, 9Division of Rheumatology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea, 10Rheumatology, Chung-Ang Univ Hospital, Seoul, South Korea, 11Division of Rheumatology, Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea, 12Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea, 13Department of Molecular Medicine and Biopharmaceutical Sciences, BK 21 plus Graduate School of Convergence Science and Technology, and College of Medicine, Seoul National University, Seoul, South Korea

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: , , ,

Session Information

Session Title: ACR Late-breaking Abstract Poster Presentations

Session Type: Late-Breaking Abstracts

Background/Purpose:

Long-term use of glucocorticoids (GC) is problematic for patients with increased risk for vertebral fractures, especially those with rheumatoid arthritis (RA). Thus, prevention of GC-induced osteoporosis (GIOP) with bisphosphonates has now become an important strategy for reducing morbidity in RA patients. Ibandronate is indicated for the treatment and prevention of osteoporosis in postmenopausal women. However, evidence for ibandronate in GIOP prevention has been insufficient to date. This aim of this study was to investigate the efficacy of monthly oral ibandronate in RA women with reduced bone mineral density receiving long-term GCs.

Methods:

Female RA patients meeting the 1987 ACR classification criteria were enrolled in this 48-week double-blinded randomized placebo-controlled trial (clinicaltrials.gov NCT01287533). Patients that had taken GC (prednisolone-equivalent dose of 5 mg or higher) for 3 or more consecutive months and fulfilling L1-4 T-score of < -1.0 and -2.5 or higher by dual-energy X-ray absorptiometry were enrolled in this study. Patients were divided into 2 groups: 150 mg ibandronate versus placebo po every 4 weeks. Both groups were provided with daily 1500 mg of calcium carbonate and cholecalciferol of 400 IU. The primary end point was to compare the % changes of the L1-4 T-score at 48 weeks compared with baseline.

Results:

Two hundred eleven patients from 13 centers nationwide participated in this study. One hundred sixty seven patients were randomized. The mean age of patients in the ibandronate and placebo group were 54.5 and 55.1 years, respectively. Baseline characteristics were not dissimilar between the 2 groups. The result of the primary endpoint is shown below (table). Serum C-terminal telopeptide was significantly reduced at 48 weeks in the ibandronate group compared with placebo (-53.1 ± 46.2 % versus 4.23 ± 58.3 %, p<0.0001, mIIT set). There was no incident of fragility fracture in both groups during the study period. Safety profiles including adverse events were comparable between the 2 groups.


Conclusion:

Monthly oral ibandronate for 48 weeks was effective in reducing bone loss in RA women on long-term glucocorticoids. Longer follow-up studies would be needed to investigate the effect of ibandronate on fracture prevention in such clinical settings.

Disclosure:

K. Shin,
None;

S. H. Park,
None;

W. Park,
None;

H. J. Baek,
None;

Y. J. Lee,
None;

S. W. Kang,
None;

J. Y. Choe,
None;

W. H. Yoo,
None;

Y. B. Park,
None;

J. S. Song,
None;

B. Yoo,
None;

D. H. Yoo,
None;

Y. W. Song,
None.

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