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CompletedNCT01287533Updated Nov 19, 2014

Efficacy of Monthly Ibandronate in Women With RA and Reduced Bone Mineral Density Receiving Long-term Steroids

A Phase 4 interventional study of Ibandronate and Placebo in Rheumatoid Arthritis, Osteoporosis and Osteopenia, sponsored by Yeong-Wook Song. Completed at 1 site in South Korea. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-11-19.

Sponsored by Yeong-Wook Song · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
167
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Female
01

Study summary

This study was to investigate the efficacy of oral monthly ibandronate in the management of glucocorticoid induced osteoporosis in women with rheumatoid arthritis.

Read the 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.

02

Conditions studied

  • Rheumatoid Arthritis
  • Osteoporosis
  • Osteopenia

Keywords

  • Rheumatoid arthritis
  • Glucocorticoid induced osteoporosis
  • Vertebral fracture
03

In context

Arthritis, Rheumatoid

2,962 studies on the registry are indexed under Arthritis, Rheumatoid; 396 are open to participants now.

This study's enrollment of 167 is above the median of 94 across 2,027 interventional studies indexed under Arthritis, Rheumatoid.

Browse Arthritis, Rheumatoid studies →

Lead sponsor

This is the only study on the registry with Yeong-Wook Song as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
167 participants (actual)

Study arms

  • Experimental
    Ibandronate treatment

    Ibandronate 150mg PO once every 4 weeks

    Drug: Ibandronate

  • Placebo comparator
    Placebo arm

    Placebo PO once every 4 weeks

    Drug: Placebo

Interventions

  • monthly dosage of ibandronate 150mg

  • DrugPlacebo

    monthly dosage of placebo

06

What researchers measure

Primary outcomes

  1. Changes in L1-4 bone mineral density compared with baseline

    Time frame: 48 weeks

Secondary outcomes

  1. Changes in femur bone mineral density compared with baseline

    Time frame: 48 weeks

  2. Changes in L1-4 and femur bone mineral density compared with baseline

    Time frame: 24 weeks

  3. Changes in C-telopeptide compared with baseline

    Time frame: 24 and 48 weeks

  4. Cumulative incidence of vertebral fracture

    Time frame: 48 weeks

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, 110-744, South Korea
08

References and documents

Publications

  • 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. PubMed 28161119 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01287533
Lead sponsor
Yeong-Wook Song
Responsible party
Yeong-Wook Song (Professor, Seoul National University Hospital) — Sponsor-investigator
First posted
Feb 1, 2011
Start date
Apr 2010
Primary completion
Apr 2014
Completion
Apr 2014
Last update
Nov 19, 2014

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Ibandronic Acid

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