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A Study of Ibandronate (Bonviva) in Patients With Post-Menopausal Osteoporosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02598440
Recruitment Status : Completed
First Posted : November 5, 2015
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This study will evaluate participant-reported preference for either ibandronate or a comparator drug in women with postmenopausal osteoporosis. The anticipated time of study treatment is 6 months, and the target sample size is 338 individuals.

Condition or disease Intervention/treatment Phase
Postmenopausal Osteoporosis Drug: Alendronate Drug: Ibandronate Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 341 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Muti-Center Study to Investigate Patient Preference on Dosing in Women With Postmenopausal Osteoporosis Treated With Once-Monthly Ibandronate and Once-Weekly Alendronate. A Six Month, Two-Sequence, and Two-Period Crossover Study
Study Start Date : March 2004
Actual Primary Completion Date : May 2005
Actual Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Arm Intervention/treatment
Experimental: Group A: Ibandronate Then Alendronate
Participants wil receive once-monthly oral ibandronate (150 mg tablet) for 3 months followed by and once-weekly oral alendronate (70 mg tablet) in crossover design for 12 weeks.
Drug: Alendronate
Participants wil receive once-weekly oral alendronate (70 mg tablet)

Drug: Ibandronate
Participants wil receive once-monthly oral ibandronate (150 mg tablet)
Other Name: Bonviva

Experimental: Group B: Alendronate Then Ibandronate
Participants will receive once-weekly oral alendronate (70 mg tablet) for 12 weeks followed by once-monthly oral ibandronate (150 mg tablet) for 3 months.
Drug: Alendronate
Participants wil receive once-weekly oral alendronate (70 mg tablet)

Drug: Ibandronate
Participants wil receive once-monthly oral ibandronate (150 mg tablet)
Other Name: Bonviva




Primary Outcome Measures :
  1. Percentage of participants preferring once-monthly dosing of ibandronate over once-weekly dosing of alendronate [ Time Frame: Up to 6 months ]

Secondary Outcome Measures :
  1. Percentage of participants perceiving the once-monthly dosing of ibandronate to be more convenient over once-weekly dosing of alendronate. [ Time Frame: Up to 6 months ]
  2. Incidence of adverse events [ Time Frame: Up to approximately 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ambulatory women
  • Diagnosis of post-menopausal osteoporosis
  • Women who have never received bisphosphonate therapy, or who have discontinued daily bisphosphonates at least 3 months prior to study entry

Exclusion Criteria:

  • Inability to stand or sit in the upright position for greater than or equal to 60 minutes
  • Allergy to bisphosphonates;
  • Previous or current treatment with weekly or monthly bisphosphonates, or daily bisphosphonates for the last 3 months prior to study entry

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02598440


Locations
Show Show 54 study locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Chair: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02598440    
Other Study ID Numbers: MA17843
First Posted: November 5, 2015    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Alendronate
Ibandronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs