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

Kichul Shin, Sung Hwan Park, Won Park, Han Joo Baek, Yun Jong Lee, Seong Wook Kang, Jung Yoon Choe, Wan Hee Yoo, Yong Beom Park, Jung Soo Song, Seung Geun Lee, Bin Yoo, Dae Hyun Yoo, Yeong Wook Song

Research output: Contribution to journalArticle

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Abstract

Purpose 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. Methods 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. Findings 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. Implications 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.

Original languageEnglish
Pages (from-to)268-278.e2
JournalClinical Therapeutics
Volume39
Issue number2
DOIs
Publication statusPublished - 2017 Feb 1

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Metabolic Bone Diseases
Glucocorticoids
Rheumatoid Arthritis
Placebos
Research Personnel
Bone and Bones
Bone Density
Fracture Fixation
Calcium Carbonate
Cholecalciferol
Femur Neck
Collagen Type I
Prednisolone
Minerals
ibandronic acid
Hip
Spine
Safety
Serum

All Science Journal Classification (ASJC) codes

  • Pharmacology
  • Pharmacology (medical)

Cite this

Shin, Kichul ; Park, Sung Hwan ; Park, Won ; Baek, Han Joo ; Lee, Yun Jong ; Kang, Seong Wook ; Choe, Jung Yoon ; Yoo, Wan Hee ; Park, Yong Beom ; Song, Jung Soo ; Lee, Seung Geun ; Yoo, Bin ; Yoo, Dae Hyun ; Song, Yeong Wook. / 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. In: Clinical Therapeutics. 2017 ; Vol. 39, No. 2. pp. 268-278.e2.
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abstract = "Purpose 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. Methods 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. Findings 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. Implications 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.",
author = "Kichul Shin and Park, {Sung Hwan} and Won Park and Baek, {Han Joo} and Lee, {Yun Jong} and Kang, {Seong Wook} and Choe, {Jung Yoon} and Yoo, {Wan Hee} and Park, {Yong Beom} and Song, {Jung Soo} and Lee, {Seung Geun} and Bin Yoo and Yoo, {Dae Hyun} and Song, {Yeong Wook}",
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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. / Shin, Kichul; Park, Sung Hwan; Park, Won; Baek, Han Joo; Lee, Yun Jong; Kang, Seong Wook; Choe, Jung Yoon; Yoo, Wan Hee; Park, Yong Beom; Song, Jung Soo; Lee, Seung Geun; Yoo, Bin; Yoo, Dae Hyun; Song, Yeong Wook.

In: Clinical Therapeutics, Vol. 39, No. 2, 01.02.2017, p. 268-278.e2.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Monthly Oral Ibandronate Reduces Bone Loss in Korean Women With Rheumatoid Arthritis and Osteopenia Receiving Long-term Glucocorticoids

T2 - A 48-week Double-blinded Randomized Placebo-controlled Investigator-initiated Trial

AU - Shin, Kichul

AU - Park, Sung Hwan

AU - Park, Won

AU - Baek, Han Joo

AU - Lee, Yun Jong

AU - Kang, Seong Wook

AU - Choe, Jung Yoon

AU - Yoo, Wan Hee

AU - Park, Yong Beom

AU - Song, Jung Soo

AU - Lee, Seung Geun

AU - Yoo, Bin

AU - Yoo, Dae Hyun

AU - Song, Yeong Wook

PY - 2017/2/1

Y1 - 2017/2/1

N2 - Purpose 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. Methods 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. Findings 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. Implications 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.

AB - Purpose 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. Methods 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. Findings 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. Implications 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.

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