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

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ClinicalTrials.gov Identifier: NCT02598453
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:
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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 545 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : January 2005
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Arm Intervention/treatment
Experimental: Ibandronate IV
Participants will receive ibandronate 3 mg IV once every 3 months
Drug: Ibandronate
Either 150 mg oral tablet once monthly or 3 mg IV injection once every 3 months
Other Name: Bonviva/Boniva

Experimental: Ibandronate Oral
Participants will receive ibandronate 150 milligrams (mg) tablet once monthly
Drug: Ibandronate
Either 150 mg oral tablet once monthly or 3 mg IV injection once every 3 months
Other Name: Bonviva/Boniva




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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 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

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): NCT02598453


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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: NCT02598453     History of Changes
Other Study ID Numbers: ML18058
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
Bone Diseases, Metabolic
Osteoporosis, Postmenopausal
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Ibandronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs