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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Yeong-Wook Song, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01287533
First received: January 30, 2011
Last updated: April 11, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention Phase
Rheumatoid Arthritis
Osteoporosis
Osteopenia
Drug: Ibandronate
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Monthly Ibandronate in Women With Rheumatoid Arthritis and Reduced Bone Mineral Density Receiving Long-term Glucocorticoids

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Changes in L1-4 bone mineral density compared with baseline [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in femur bone mineral density compared with baseline [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Changes in L1-4 and femur bone mineral density compared with baseline [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Changes in C-telopeptide compared with baseline [ Time Frame: 24 and 48 weeks ] [ Designated as safety issue: No ]
  • Cumulative incidence of vertebral fracture [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: April 2010
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ibandronate treatment
Ibandronate 150mg PO once every 4 weeks
Drug: Ibandronate
monthly dosage of ibandronate 150mg
Placebo Comparator: Placebo arm
Placebo PO once every 4 weeks
Drug: Placebo
monthly dosage of placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01287533

Contacts
Contact: Kichul Shin, MD kideb1@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Kichul Shin, MD       kideb1@gmail.com   
Principal Investigator: Yeong Wook Song, MD, PhD         
Sponsors and Collaborators
Yeong-Wook Song
  More Information

No publications provided

Responsible Party: Yeong-Wook Song, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01287533     History of Changes
Other Study ID Numbers: 112942
Study First Received: January 30, 2011
Last Updated: April 11, 2013
Health Authority: Korea: Food and Drug Administration
Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
Rheumatoid arthritis
Glucocorticoid induced osteoporosis
Vertebral fracture

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Bone Diseases, Metabolic
Osteoporosis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bone Diseases
Glucocorticoids
Ibandronic acid
Diphosphonates
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on July 23, 2014