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A Study of Ibandronate (Boniva) to Evaluate Satisfaction in Women With Post-Menopausal Osteoporosis or Osteopenia

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: NCT02604836
Recruitment Status : Completed
First Posted : November 13, 2015
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This study will investigate participant satisfaction (including compliance, preference, tolerability) with once-monthly Bonviva in women with post-menopausal osteoporosis or osteopenia transitioned from once-weekly alendronate or risedronate. The anticipated time on study treatment is 6 months, and the target sample size is 1776 individuals.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1711 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Open-Label, Multi-Center, Two-Part Study to Investigate Patient Satisfaction With Monthly Dosed Ibandronate Therapy in Women With Post-Menopausal Osteoporosis or Osteopenia Transitioned From Once-Weekly Alendronate or Risendronate
Study Start Date : June 2004
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ibandronate
Participants will receive 150 milligrams (mg) of ibandronate as a film-coated tablet once-monthly.
Drug: Ibandronate
Film-coated oral ibandronate tablet (150 mg) once-monthly
Other Name: Bonviva/Boniva




Primary Outcome Measures :
  1. Part A: Number of participants who currently use weekly biphosphonate who answer "yes" to any of the questions in Candidate Identification Questionnaire (CIQ) [ Time Frame: Up to 30 days prior to baseline visit ]
  2. Part B: Number of participants who demonstrate improvement from their baseline satisfaction score after 6 months of ibandronate [ Time Frame: 6 months ]
  3. Part B: Percentage of participants who demonstrate improvement from their baseline satisfaction score after 6 months of ibandronate [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Part B: Percentage of eligible weekly biphosphonate users at screening who elect to enter Part B [ Time Frame: Screening visit ]
  2. Part B: Percentage of participants who report an improved satisfaction score with monthly ibandronate compared to weekly alendronate or risendronate [ Time Frame: 6 months ]
  3. Part B: Percentage of participants who report preference to monthly ibandronate or weekly alendronate or risedronate [ Time Frame: 6 months ]
  4. Part B: Percentage of participants who have greater than or equal to (>=) 80 percent (%) compliance [ Time Frame: 6 months ]
  5. Part B: Percentage of participants who report an improvement in the gastrointestinal (GI) symptoms [ Time Frame: 6 months ]
  6. Part B: Percentage of participants by age and activity level who report high satisfaction according to Osteoporosis Patient Survey satisfaction Questionnaire (OPSAT-Q) [ Time Frame: 6 months ]
  7. Part B: Individual Domain scores from Osteoporosis Patient Survey satisfaction Questionnaire (OPSAT-Q) [ Time Frame: Baseline and 6 months ]
  8. Part B: Number of eligible weekly biphosphonate users at screening who elect to enter Part B [ Time Frame: Screening Visit ]
  9. Part B: Number of participants who report an improved satisfaction score with monthly ibandronate compared to weekly alendronate or risendronate [ Time Frame: 6 months ]
  10. Part B: Number of participants who report preference to monthly ibandronate or weekly alendronate or risedronate [ Time Frame: 6 months ]
  11. Part B: Number of participants who have >= 80% compliance [ Time Frame: 6 months ]
  12. Part B: Number of participants who report an improvement in the GI symptoms [ Time Frame: 6 months ]
  13. Part B: Number of participants by age and activity level who report high satisfaction according to Osteoporosis Patient Survey satisfaction Questionnaire (OPSAT-Q) [ Time Frame: 6 months ]


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:

- Women who had been receiving once-weekly alendronate or risedronate for treatment or prevention of post-menopausal osteoporosis for greater than or equal to (>=) 3 months

Exclusion Criteria:

  • Inability to stand or sit upright for >=60 minutes
  • Hypersensitivity to bisphosphonates
  • Inability to swallow a tablet whole
  • Malignant disease diagnosed within previous 10 years (except resected basal cell cancer).

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): NCT02604836


Locations
Show Show 142 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: NCT02604836    
Other Study ID Numbers: ML18056
First Posted: November 13, 2015    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Osteoporosis, Postmenopausal
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Ibandronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs