A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis.

Randomized, Open-label, Multi-center Study to Investigate Patient Preference on Dosing in Women With Postmenopausal Osteoporosis Treated With Once Monthly Ibandronate and Once Weekly Risedronate. A Six Month, Two-sequence and Two-period Crossover Study.

This 2 arm crossover study will evaluate patient reported preference for either once monthly Boniva (150mg p.o.) or once weekly risedronate (35mg p.o.). Patients with post-menopausal osteoporosis will be randomized to receive Boniva for 3 calendar months or risedronate for 12 weeks; they will then cross over to receive the alternative treatment for a further 12 weeks/3 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Study Overview

• Status: Completed
• Conditions: Post Menopausal Osteoporosis
• Intervention / Treatment: Drug: ibandronate [Bonviva/Boniva]; Drug: Risedronate

• Study Type: Interventional
• Enrollment (Actual): 356
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-3708
  • Arizona
    • Mesa, Arizona, United States, 85213
    • Scottsdale, Arizona, United States, 85251
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
  • California
    • Anaheim, California, United States, 92801
    • San Diego, California, United States, 92108
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
  • Florida
    • Boynton Beach, Florida, United States, 33437
    • Jupiter, Florida, United States, 33458
    • Largo, Florida, United States, 33777
    • Leesburg, Florida, United States, 34748
    • Merritt Island, Florida, United States, 32952
    • Ocala, Florida, United States, 34471
    • Pembroke Pines, Florida, United States, 33024
    • Spring Hill, Florida, United States, 34667
    • St Petersburg, Florida, United States, 33606
    • Tampa, Florida, United States, 33614
    • West Palm Beach, Florida, United States, 33409
  • Georgia
    • Douglasville, Georgia, United States, 30134
    • Gainesville, Georgia, United States, 30501
    • Marietta, Georgia, United States, 30060
  • Kentucky
    • Madisonville, Kentucky, United States, 42431
  • Maryland
    • Bethesda, Maryland, United States, 20817
  • Montana
    • Missoula, Montana, United States, 59801
  • Nebraska
    • Omaha, Nebraska, United States, 68134
  • North Carolina
    • Morehead City, North Carolina, United States, 28557
    • New Bern, North Carolina, United States, 28562
  • North Dakota
    • Jamestown, North Dakota, United States, 58401
  • Ohio
    • Cincinnati, Ohio, United States, 45236
    • Cincinnati, Ohio, United States, 45224
    • Mogadore, Ohio, United States, 44260
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
    • Erie, Pennsylvania, United States, 16506
    • Feasterville, Pennsylvania, United States, 19053
    • Philadelphia, Pennsylvania, United States, 19114
  • South Carolina
    • Anderson, South Carolina, United States, 29621
  • Tennessee
    • Memphis, Tennessee, United States, 38120
    • Selmer, Tennessee, United States, 38375
  • Texas
    • Bedford, Texas, United States, 76021
    • Bryan, Texas, United States, 77802
    • Dallas, Texas, United States, 75231
    • Houston, Texas, United States, 77030
    • Houston, Texas, United States, 77024
    • Temple, Texas, United States, 76502
  • Virginia
    • Richmond, Virginia, United States, 23235
    • Richmond, Virginia, United States, 23294
  • Washington
    • Seattle, Washington, United States, 98105

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• ambulatory women with post-menopausal osteoporosis;
• patients who are bisphosphonate-naive, or who have previously received oral daily or i.v. bisphosphonate therapy (fulfilling certain criteria detailed in the protocol).

Exclusion Criteria:

• malignant disease diagnosed within previous 10 years (except for successfully resected basal cell cancer;) breast cancer within previous 20 years;
• inability to stand or sit upright for at least 60 minutes;
• disease/disorder/treatment with drugs known to influence bone metabolism.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: ibandronate [Bonviva/Boniva]; 150mg po monthly for 3 months
Active Comparator: 2	Drug: Risedronate; 35mg po weekly for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Preferred Ibandronate Monthly Dosing to Risedronate Weekly Dosing	Patients who had taken at least one dose of each study medication were asked to answer a Preference Questionnaire (answered by patients before any study procedures took place at the 6 month visit or at the early termination visit). The questionnaire included three questions on the preferred dosing schedule, and one question asking which schedule was more convenient. No assistance was allowed in completing the questionnaire.	at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Found Once-monthly Ibandronate to be More Convenient Than Once-weekly Risedronate	Patients who had taken at least one dose of each study medication were asked to answer a Preference Questionnaire (answered by patients before any study procedures took place at the 6 month visit or at the early termination visit). The questionnaire included three questions on the preferred dosing schedule, and one question asking which schedule was more convenient. No assistance was allowed in completing the questionnaire.	within 6 months
Intensity of Upper Gastrointestinal (GI) Symptoms	Patients were given a diary in which to record their upper GI events during the first 12 weeks of treatment. The diary was to be completed weekly and the occurrence of symptoms and their intensity recorded using a pre-defined list.	within 3 months
Mean Change From Baseline in Bone Resorption and Bone Formation Markers, Serum C-telopeptide of α-chain of Type I Collagen (CTX) and Bone Specific Alkaline Phosphatase (BSAP)	During the conduct of this study, it came to the attention of the sponsor that mislabeling of blood samples for the analysis of the bone turnover markers, serum CTX and BSAP, had occurred at more than half of the 44 clinical trial sites. As a result of this mislabeling, the bone turnover marker samples could not be assigned correctly to the two time points at which they were collected (samples collected at baseline and those collected at the crossover visit which occurred after 3 months following the start of trial treatment). Thus, the results of bone turnover markers could not be reliably assessed. Therefore, summary tables showing the mean and median change from baseline for both serum CTX and BSAP for patients randomized to Sequence A (3 months of ibandronate followed by 12 weeks of risedronate) or Sequence B (12 weeks of risedronate followed by 3 months of ibandronate) are not presented, as a valid interpretation of the data cannot be made.	3 months
Median Change From Baseline in Bone Resorption and Bone Formation Markers, Serum C-telopeptide of α-chain of Type I Collagen (CTX) and Bone Specific Alkaline Phosphatase (BSAP)	During the conduct of this study, it came to the attention of the sponsor that mislabeling of blood samples for the analysis of the bone turnover markers, serum CTX and BSAP, had occurred at more than half of the 44 clinical trial sites. As a result of this mislabeling, the bone turnover marker samples could not be assigned correctly to the two time points at which they were collected (samples collected at baseline and those collected at the crossover visit which occurred after 3 months following the start of trial treatment). Thus, the results of bone turnover markers could not be reliably assessed. Therefore, summary tables showing the mean and median change from baseline for both serum CTX and BSAP for patients randomized to Sequence A (3 months of ibandronate followed by 12 weeks of risedronate) or Sequence B (12 weeks of risedronate followed by 3 months of ibandronate) are not presented, as a valid interpretation of the data cannot be made.	3 months

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: September 15, 2006
• First Submitted That Met QC Criteria: September 15, 2006
• First Posted (Estimate): September 18, 2006

Study Record Updates

• Last Update Posted (Estimate): August 1, 2016
• Last Update Submitted That Met QC Criteria: July 28, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Osteoporosis, Postmenopausal; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Risedronic Acid; Ibandronic Acid
• Other Study ID Numbers: MA19547