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Post Menopausal OsteoporosisPhase 4NCT00377234

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

A Phase 4 study testing Risedronate and ibandronate [Bonviva/Boniva] in people with Post Menopausal Osteoporosis, run by Hoffmann-La Roche at 48 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 55 to 80 years, women only
Conditions the study is for
Post Menopausal Osteoporosis
What is being tested?
Risedronate and ibandronate [Bonviva/Boniva]
Could I receive a placebo?
No, everyone receives an active treatment
How many people
356 participants
Where
48 sitesUnited States
Study dates
May 2006to Aug 2008
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

48 sites in 1 country.

48 sites in 1 country

United States48 sites

  • Study site

    Anaheim, California, 92801

  • Study site

    Anderson, South Carolina, 29621

  • Study site

    Bedford, Texas, 76021

  • Study site

    Bethesda, Maryland, 20817

  • Study site

    Birmingham, Alabama, 35294-3708

  • Study site

    Boynton Beach, Florida, 33437

  • Study site

    Bryan, Texas, 77802

  • Study site

    Cincinnati, Ohio, 45224

  • Study site

    Cincinnati, Ohio, 45236

  • Study site

    Dallas, Texas, 75231

  • Study site

    Douglasville, Georgia, 30134

  • Study site

    Duncansville, Pennsylvania, 16635

  • Study site

    Erie, Pennsylvania, 16506

  • Study site

    Feasterville, Pennsylvania, 19053

  • Study site

    Gainesville, Georgia, 30501

  • Study site

    Houston, Texas, 77024

  • Study site

    Houston, Texas, 77030

  • Study site

    Jamestown, North Dakota, 58401

  • Study site

    Jonesboro, Arkansas, 72401

  • Study site

    Jupiter, Florida, 33458

  • Study site

    Largo, Florida, 33777

  • Study site

    Leesburg, Florida, 34748

  • Study site

    Madisonville, Kentucky, 42431

  • Study site

    Marietta, Georgia, 30060

  • Study site

    Memphis, Tennessee, 38120

  • Study site

    Merritt Island, Florida, 32952

  • Study site

    Mesa, Arizona, 85213

  • Study site

    Missoula, Montana, 59801

  • Study site

    Mogadore, Ohio, 44260

  • Study site

    Morehead City, North Carolina, 28557

  • Study site

    New Bern, North Carolina, 28562

  • Study site

    Ocala, Florida, 34471

  • Study site

    Omaha, Nebraska, 68134

  • Study site

    Pembroke Pines, Florida, 33024

  • Study site

    Philadelphia, Pennsylvania, 19114

  • Study site

    Richmond, Virginia, 23235

  • Study site

    Richmond, Virginia, 23294

  • Study site

    San Diego, California, 92108

  • Study site

    Scottsdale, Arizona, 85251

  • Study site

    Seattle, Washington, 98105

  • Study site

    Selmer, Tennessee, 38375

  • Study site

    Spring Hill, Florida, 34667

  • Study site

    St. Petersburg, Florida, 33606

  • Study site

    Tampa, Florida, 33614

  • Study site

    Temple, Texas, 76502

  • Study site

    Tulsa, Oklahoma, 74104

  • Study site

    Waterbury, Connecticut, 06708

  • Study site

    West Palm Beach, Florida, 33409

Other trials in United States

About this study

Official title: 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.

Being tested
Risedronate, ibandronate [Bonviva/Boniva]
Medical subject headings
Osteoporosis, Postmenopausal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RisedronateDrug

    35mg po weekly for 12 weeks

  • ibandronate [Bonviva/Boniva]Drug

    150mg po monthly for 3 months

Study groups in NCT00377234
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: ibandronate [Bonviva/Boniva]
2Active comparatorNot described
Receives: Drug: Risedronate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: at 6 months

Secondary outcomes (4)

  1. 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.

    Measured: within 6 months

  2. 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.

    Measured: within 3 months

  3. 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.

    Measured: 3 months

  4. 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.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionAug 2008
  4. Study completionAug 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
356 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00377234
Sponsor's protocol ID
MA19547
Status last verified
Jul 2016
First submitted
15 Sep 2006
Last updated
1 Aug 2016

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Risedronate and ibandronate [Bonviva/Boniva] in people with Post Menopausal Osteoporosis, run by Hoffmann-La Roche at 48 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Preferred Ibandronate Monthly Dosing to Risedronate Weekly Dosing (time frame: at 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00377234.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2016.

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