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Completed

NCT Number: NCT02598453

PRIOR Study - A Study of Ibandronate (Boniva) in Postmenopausal Women With Osteoporosis or Osteopenia

The purpose of this study is to evaluate treatment adherence to different regimens of ibandronate in postmenopausal women with osteoporosis or osteopenia who are intolerant to daily or weekly alendronate or risedronate therapy due to gastrointestinal (GI) side effects. The anticipated time on study treatment is 12 months, and the target sample size is 517 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

Montgomery, 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 with postmenopausal osteoporosis or osteopenia
  • Discontinuation of daily and /or weekly alendronate or risedronate therapy because of GI intolerance (eg, heartburn, acid reflux, stomach upset)

Exclusion criteria

  • Inability to stand or sit upright for 60 minutes
  • Inability to swallow a tablet whole - Hypersensitivity to any component of Boniva
  • Malignant disease diagnosed within previous 10 years (except resected basal cell cancer); contraindications for calcium or vitamin D therapy
  • Patients who do not fulfill a minimum 3 months wash-out therapy from any previous bisphosphonate therapy

Treatment and study plan

Ibandronate

Drug

Either 150 mg oral tablet once monthly or 3 mg IV injection once every 3 months

Other names: Bonviva/Boniva

Primary outcomes

  1. Percentage of participants who have greater than or equal to (>=) 75 percent (%) adherence using either monthly oral ibandronate or quarterly intravenous (IV) ibandronate

    Time frame: 12 months

Secondary outcomes

  1. Percentage of participants who have an adherence of >= 75% using ibandronate including both switch and non-switch participants

    Time frame: 12 months

  2. Percentage of participants with GI events based on severity

    Time frame: Up to 10 months

  3. Percentage of participants who experienced a change in frequency and number of GI events

    Time frame: Up to 10 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Open-Label, Multi-Center Study to Determine Level of Adherence to Monthly Oral or Every Three Month Intravenous Ibandronate Treatment in Post-Menopausal Women With Osteoporosis or Osteopenia, Who Are GI Intolerant of Daily or Weekly Alendronate or Risendronate

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Nov 5, 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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