NCT01287533

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
167

participants targeted

Target at P50-P75 for phase_4 rheumatoid-arthritis

Timeline
Completed

Started Apr 2010

Typical duration for phase_4 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2011

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

November 19, 2014

Status Verified

November 1, 2014

Enrollment Period

4 years

First QC Date

January 30, 2011

Last Update Submit

November 18, 2014

Conditions

Rheumatoid ArthritisOsteoporosisOsteopenia

Keywords

Rheumatoid arthritisGlucocorticoid induced osteoporosisVertebral fracture

Outcome Measures

Primary Outcomes (1)

  • Changes in L1-4 bone mineral density compared with baseline

    48 weeks

Secondary Outcomes (4)

  • Changes in femur bone mineral density compared with baseline

    48 weeks

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

    24 weeks

  • Changes in C-telopeptide compared with baseline

    24 and 48 weeks

  • Cumulative incidence of vertebral fracture

    48 weeks

Study Arms (2)

Ibandronate treatment

EXPERIMENTAL

Ibandronate 150mg PO once every 4 weeks

Drug: Ibandronate

Placebo arm

PLACEBO COMPARATOR

Placebo PO once every 4 weeks

Drug: Placebo

Interventions

IbandronateDRUG

monthly dosage of ibandronate 150mg

Ibandronate treatment
PlaceboDRUG

monthly dosage of placebo

Placebo arm

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 28161119DERIVED

MeSH Terms

Conditions

Arthritis, RheumatoidOsteoporosisBone Diseases, MetabolicSpinal Fractures

Interventions

Ibandronic Acid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBone DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesSpinal InjuriesBack InjuriesWounds and InjuriesFractures, Bone

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 30, 2011

First Posted

February 1, 2011

Study Start

April 1, 2010

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

November 19, 2014

Record last verified: 2014-11

Locations

KR(1)