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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01287533
Other study ID # 112942
Secondary ID
Status Completed
Phase Phase 4
First received January 30, 2011
Last updated November 18, 2014
Start date April 2010
Est. completion date April 2014

Study information

Verified date November 2014
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug AdministrationKorea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 167
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Intervention

Drug:
Ibandronate
monthly dosage of ibandronate 150mg
Placebo
monthly dosage of placebo

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yeong-Wook Song

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in L1-4 bone mineral density compared with baseline 48 weeks No
Secondary Changes in femur bone mineral density compared with baseline 48 weeks No
Secondary Changes in L1-4 and femur bone mineral density compared with baseline 24 weeks No
Secondary Changes in C-telopeptide compared with baseline 24 and 48 weeks No
Secondary Cumulative incidence of vertebral fracture 48 weeks No
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