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Completed

NCT Number: NCT02604836

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

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.

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Key information

Conditions

Postmenopausal Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Ibandronate

Drug

Film-coated oral ibandronate tablet (150 mg) once-monthly

Other names: Bonviva/Boniva

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Nov 13, 2015
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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