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

Rheumatoid Arthritis Clinical Trial

Official title:

Efficacy of Monthly Ibandronate in Women With Rheumatoid Arthritis and Reduced Bone Mineral Density Receiving Long-term Glucocorticoids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01287533
• Other study ID #: 112942
• 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Osteopenia
• Osteoporosis
• Rheumatoid Arthritis

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