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

NCT02604836 | Completed Phase 4

• 1 other identifier: ML18056
• Study Type: interventional
• Target: 1,711
• Locations: 1 country
• Sites: 142

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.

Conditions

Postmenopausal Osteoporosis

Outcome Measures

Primary Outcomes (3)

• Part A: Number of participants who currently use weekly biphosphonate who answer "yes" to any of the questions in Candidate Identification Questionnaire (CIQ)

  Up to 30 days prior to baseline visit

• Part B: Number of participants who demonstrate improvement from their baseline satisfaction score after 6 months of ibandronate

  6 months

• Part B: Percentage of participants who demonstrate improvement from their baseline satisfaction score after 6 months of ibandronate

  6 months

Secondary Outcomes (13)

• Part B: Percentage of eligible weekly biphosphonate users at screening who elect to enter Part B

  Screening visit

• Part B: Percentage of participants who report an improved satisfaction score with monthly ibandronate compared to weekly alendronate or risendronate

  6 months

• Part B: Percentage of participants who report preference to monthly ibandronate or weekly alendronate or risedronate

  6 months

• Part B: Percentage of participants who have greater than or equal to (>=) 80 percent (%) compliance

  6 months

• Part B: Percentage of participants who report an improvement in the gastrointestinal (GI) symptoms

  6 months

Study Arms (1)

Ibandronate

EXPERIMENTAL

Participants will receive 150 milligrams (mg) of ibandronate as a film-coated tablet once-monthly.

Drug: Ibandronate

Interventions

Ibandronate DRUG

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

Also known as: Bonviva/Boniva

Ibandronate

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (142)

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Birmingham, Alabama, 35235, United States

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Columbiana, Alabama, 35051, United States

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Huntsville, Alabama, 35801, United States

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Mobile, Alabama, 36608, United States

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Montgomery, Alabama, 36111, United States

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Chandler, Arizona, 85225, United States

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Gilbert, Arizona, 85295, United States

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Paradise Valley, Arizona, 85253, United States

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Phoenix, Arizona, 85006, United States

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Phoenix, Arizona, 85014, United States

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Tempe, Arizona, 85282, United States

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Tucson, Arizona, 85712, United States

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Carlisle, Arkansas, 72024, United States

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Jonesboro, Arkansas, 72401, United States

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Little Rock, Arkansas, 72205, United States

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Pine Bluff, Arkansas, 71603, United States

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Rogers, Arkansas, 72756, United States

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Searcy, Arkansas, 72143, United States

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Sherwood, Arkansas, 72120, United States

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Anaheim, California, 92801, United States

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Beverly Hills, California, 90211, United States

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Laguna Hills, California, 92653, United States

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Mission Viejo, California, 92691, United States

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Palm Desert, California, 92260, United States

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Palo Alto, California, 94304, United States

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Sacramento, California, 95825, United States

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San Diego, California, 92128, United States

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Tacoma, California, 98405, United States

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Vista, California, 92083, United States

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Westlake Village, California, 91361, United States

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Colorado Springs, Colorado, 80909, United States

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Lakewood, Colorado, 80260, United States

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Avon, Connecticut, 06001, United States

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Cromwell, Connecticut, 06416, United States

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Hamden, Connecticut, 06518, United States

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New London, Connecticut, 06320, United States

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Waterbury, Connecticut, 06708, United States

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Wilmington, Delaware, 19805, United States

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Aventura, Florida, 33180, United States

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Clearwater, Florida, 33761, United States

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DeLand, Florida, 32720, United States

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Fort Myers, Florida, 33916, United States

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Gainesville, Florida, 32605, United States

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Gainesville, Florida, 32607, United States

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Longwood, Florida, 32779, United States

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Melbourne, Florida, 32901, United States

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Miami, Florida, 33186, United States

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Ocala, Florida, 34471, United States

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Palm Bay, Florida, 32905, United States

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Palm Harbor, Florida, 34684, United States

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Port Orange, Florida, 32127, United States

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Sarasota, Florida, 34239, United States

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West Palm Beach, Florida, 33409, United States

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Atlanta, Georgia, 30309, United States

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Augusta, Georgia, 30904, United States

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Decatur, Georgia, 30033, United States

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Rome, Georgia, 30165, United States

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Boise, Idaho, 83712, United States

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Coeur d'Alene, Idaho, 83814, United States

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Champaign, Illinois, 61820, United States

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Creve Coeur, Illinois, 61610, United States

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Peoria, Illinois, 61615, United States

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Evansville, Indiana, 47714, United States

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Arkansas City, Kansas, 67005, United States

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Newton, Kansas, 67114, United States

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Wichita, Kansas, 67207, United States

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Natchitoches, Louisiana, 71457, United States

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New Orleans, Louisiana, 70119, United States

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Baltimore, Maryland, 21204, United States

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Bethesda, Maryland, 20817, United States

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Chelsea, Michigan, 48118, United States

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Detroit, Michigan, 48202, United States

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Saint Joseph, Michigan, 49085, United States

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Chaska, Minnesota, 55318, United States

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Jefferson City, Missouri, 65109, United States

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Kansas City, Missouri, 64108, United States

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Kansas City, Missouri, 64114, United States

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St Louis, Missouri, 63110, United States

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St Louis, Missouri, 63117, United States

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St Louis, Missouri, 63128, United States

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St Louis, Missouri, 63141, United States

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Billings, Montana, 59101, United States

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Omaha, Nebraska, 68131, United States

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Clifton, New Jersey, 07012, United States

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Middletown, New Jersey, 07748, United States

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New Brunswick, New Jersey, 08901, United States

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Princeton, New Jersey, 08540, United States

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Brooklyn, New York, 11201, United States

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East Syracuse, New York, 13057, United States

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New York, New York, 10011, United States

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Olean, New York, 14760, United States

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Rochester, New York, 14609, United States

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Stony Brook, New York, 11794-8161, United States

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Durham, North Carolina, 27704, United States

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Durham, North Carolina, 27705, United States

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Fayetteville, North Carolina, 28304, United States

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Morehead City, North Carolina, 28557, United States

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Morganton, North Carolina, 28655, United States

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Raleigh, North Carolina, 27609, United States

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Salisbury, North Carolina, 28144, United States

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Wilmington, North Carolina, 28401, United States

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Winston-Salem, North Carolina, 27103, United States

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Fargo, North Dakota, 58103, United States

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Grand Forks, North Dakota, 58201, United States

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Beachwood, Ohio, 44122, United States

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Canfield, Ohio, 44406, United States

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Cincinnati, Ohio, 45246, United States

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Columbus, Ohio, 43213, United States

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Oklahoma City, Oklahoma, 73112, United States

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Tulsa, Oklahoma, 74104, United States

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Medford, Oregon, 97504, United States

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Portland, Oregon, 97210, United States

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Bala-Cynwyd, Pennsylvania, 19004, United States

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Langhorne, Pennsylvania, 19047, United States

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Philadelphia, Pennsylvania, 19114, United States

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Philadelphia, Pennsylvania, 19131, United States

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Wyomissing, Pennsylvania, 19610, United States

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Charleston, South Carolina, 29425, United States

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Mt. Pleasant, South Carolina, 29464, United States

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Spartanburg, South Carolina, 29307, United States

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Bristol, Tennessee, 37620, United States

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Memphis, Tennessee, 38103, United States

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Murfreesboro, Tennessee, 37130, United States

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Nashville, Tennessee, 37203, United States

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Sevierville, Tennessee, 37862, United States

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Carrollton, Texas, 75010, United States

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Corpus Christi, Texas, 78414, United States

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Dallas, Texas, 75231, United States

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Denton, Texas, 76210, United States

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San Antonio, Texas, 78229, United States

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Wichita Falls, Texas, 76309, United States

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Norfolk, Virginia, 23502, United States

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Norfolk, Virginia, 23507-1912, United States

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Richmond, Virginia, 23226, United States

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Richmond, Virginia, 23294, United States

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Renton, Washington, 98055, United States

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Seattle, Washington, 98105, United States

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Seattle, Washington, 98144, United States

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Spokane, Washington, 99207, United States

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Tacoma, Washington, 98405, United States

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Madison, Wisconsin, 53705, United States

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Milwaukee, Wisconsin, 53209, United States

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MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Ibandronic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2015
• First Posted: November 13, 2015
• Study Start: June 1, 2004
• Primary Completion: April 1, 2006
• Study Completion: April 1, 2006
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

US (142)