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.
Our aim was to investigate the efficacy of monthly oral ibandronate in Korean women with rheumatoid arthritis and reduced bone mineral density (BMD) receiving long-term glucocorticoids.



Patients (n = 167 women) were randomly assigned (1:1) to receive ibandronate 150 mg or placebo every 4 weeks. Patients had taken glucocorticoid (equivalent of daily prednisolone ≥5 mg) for 3 or more consecutive months before enrollment, and had a lumbar spine 1 to 4 (L1-L4) T-score of < -1.0 and ≥ -2.5. Both groups were provided with daily calcium carbonate and cholecalciferol. The primary end point was the L1 to L4 BMD percent changes at 48 weeks compared with baseline.



Baseline characteristics were comparable between the 2 groups. BMD percent changes in L1 to L4 at 48 weeks were significantly different between the ibandronate versus the placebo group (+3.7% [5.1%] vs -1.9% [4.4%], respectively; P < 0.0001). BMD percent changes at 48 weeks in femur neck and total hip also had similar results (P = 0.0073 and P = 0.0031, respectively). Decrease of serum type 1 collagen C-terminal telopeptide was significant at both 24 and 48 weeks in the ibandronate group. 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.



Monthly oral ibandronate for 48 weeks is well tolerated and effective in reducing bone mineral loss in women with rheumatoid arthritis on long-term glucocorticoid therapy. Longer follow-up studies are needed to investigate the benefit of ibandronate on fracture rate reduction in this subset of patients. ClinicalTrials.gov identifier: NCT01287533.
Division of Rheumatology, Seoul Metropolitan Government, Seoul National University Boramae Medical Center, Seoul, Korea.
Kichul
K
Shin
Division of Rheumatology, Catholic University of Korea, Seoul St. Mary׳s Hospital, Seoul, Korea.
Sung-Hwan
SH
Park
Division of Rheumatology, Inha University Hospital, Incheon, Korea.
Won
W
Park
Division of Rheumatology, Gachon University Gil Medical Center, Incheon, Korea.
Han Joo
HJ
Baek
Division of Rheumatology, Seoul National University Bundang Hospital, Seoul, Korea.
Yun Jong
YJ
Lee
Division of Rheumatology, Chungnam National University Hospital, Daejeon, Korea.
Seong Wook
SW
Kang
Division of Rheumatology, Daegu Catholic University Medical Center, Daegu, Korea.
Jung-Yoon
JY
Choe
Division of Rheumatology, Chonbuk National University Hospital, Jeonju, Korea.
Wan-Hee
WH
Yoo
Division of Rheumatology, Yonsei University College of Medicine, Severance Hospital, Seoul, Korea.
Yong-Beom
YB
Park
Division of Rheumatology, Chung-Ang University Hospital, Seoul, Korea.
Jung-Soo
JS
Song
Division of Rheumatology, Department of Internal Medicine, Pusan National University Hospital Institutes, Pusan, Korea.
Seung-Geun
SG
Lee
Division of Rheumatology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
Bin
B
Yoo
Division of Rheumatology, Hanyang University Medical Center, Seoul, Korea.
Dae-Hyun
DH
Yoo
Divsion of Rheumatology, Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea; Department of Molecular Medicine and Biopharmaceutical Sciences, Graduate School of Convergence Science and Technology, Medical Research Center, Seoul National University, Seoul, Korea. Electronic address: ysong@snu.ac.kr.
Yeong Wook
YW
Song
D000328:Adult; D000368:Aged; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D015519:Bone Density / Q000187:drug effects; D001851:Bone Diseases, Metabolic / Q000188:drug therapy*; D024042:Collagen Type I / Q000097:blood; D004164:Diphosphonates / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D050723:Fractures, Bone / Q000453:epidemiology; D005938:Glucocorticoids / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D000077557:Ibandronic Acid; D008159:Lumbar Vertebrae; D008875:Middle Aged; D010455:Peptides / Q000097:blood
D024042:Collagen Type I; D004164:Diphosphonates; D005938:Glucocorticoids; D010455:Peptides; C052929:collagen type I trimeric cross-linked peptide; D000077557:Ibandronic Acid
bone mineral density; corticosteroids; osteoporosis; rheumatoid arthritis