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Study To Investigate Patient Preference On Dosing In Ibandronate And Risedronate In Korean Women With Postmenopausal Osteoporosis

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00405392
First received: November 29, 2006
Last updated: January 17, 2012
Last verified: October 2010
  Purpose

This is a randomized open label, multi-centre study for Korean women with postmenopausal osteoporosis, evaluating the preference for either the once-monthly dosing of ibandronate or the once-weekly dosing of risedronate.

Eligible subjects will be randomised either ibandronate monthly regimen or risedronate weekly regimen.

Treatment period consists of 3 month with ibandronate 150mg and additional 12 week with risedronate 35 mg or vice versa.

After taking the first interventional medicine for 3 months or 12 weeks completely, a subject changes the treatment arm. There is no washout period.


Condition Intervention Phase
Postmenopausal Osteoporosis
Drug: Ibandronate (SB743830HD)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Multi-centre, Randomized Study to Investigate Patient Preference on Dosing in the Once-monthly Ibandronate and the Once-weekly Risedronate in Korean Women With Postmenopausal Osteoporosis. A Six-month, Two-sequence, and Two Period Crossover Study

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Proportion(%) of patients who prefer the once-monthly dosing of ibandronate to the once-weekly dosing of risedronate.

Secondary Outcome Measures:
  • Percentage of patients who think once-monthly ibandronate dosing is more convenient vs once-weekly risedronate dosing Mean percent change of serum CTx from baseline to visit3 for once-monthly dosing of ibandronate & once-weekly dosing of risedronate

Estimated Enrollment: 364
Study Start Date: March 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Ibandronate (SB743830HD)
    Other Name: Ibandronate (SB743830HD)
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with postmenopausal osteoporosis diagnosed by DXA scanning, defined by T-score of -2.5 SD at spine or femur.
  • Patients who have never received bisphosphonates therapy (bisphosphonates naive)

Exclusion Criteria:

  • Inability to stand or sit in the upright position for at least 60 minutes;
  • Hypersensitivity to any component of risedronate and ibandronate;
  • Administration of any investigational drug within 30 days preceding the first dose of the study drug;
  • Patient has been on hormone (estrogen) replacement therapy or other osteoporosis medication (e.g. SERMS and calcitonin) within the previous 3 months.
  • Patient has been on systemic corticosteroids therapy for more than 1 month within the past year.
  • Other bone disease except osteoporosis
  • Current medical history of uncontrolled major upper GI disease
  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: NCT00405392

Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: GSK Clinical Trials, MD, PhD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00405392     History of Changes
Other Study ID Numbers: 109393, ML20293
Study First Received: November 29, 2006
Last Updated: January 17, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Hoffmann-La Roche:
Ibandronate
risedronate
Osteoporosis
preference

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Diphosphonates
Ibandronic acid
Risedronic acid
Bone Density Conservation Agents
Calcium Channel Blockers
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014