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

NCT ID: NCT01287533

Last Updated: 2014-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

167 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2014-04-30

Brief Summary

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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

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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.

Conditions

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Rheumatoid Arthritis Osteoporosis Osteopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ibandronate treatment

Ibandronate 150mg PO once every 4 weeks

Group Type EXPERIMENTAL

Ibandronate

Intervention Type DRUG

monthly dosage of ibandronate 150mg

Placebo arm

Placebo PO once every 4 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

monthly dosage of placebo

Interventions

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Ibandronate

monthly dosage of ibandronate 150mg

Intervention Type DRUG

Placebo

monthly dosage of placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Yeong-Wook Song

OTHER

Sponsor Role lead

Responsible Party

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Yeong-Wook Song

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 28161119 (View on PubMed)

Other Identifiers

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112942

Identifier Type: -

Identifier Source: org_study_id