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

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status and phase

Completed
Phase 4

Conditions

Osteoporosis, Postmenopausal

Treatments

Drug: Ibandronate (SB743830HD)

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

365 patients

Sex

Female

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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