A Study of Bonviva (Ibandronate) and Alendronate on Renal Function in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease.

May 17, 2011 updated by: Hoffmann-La Roche

A Randomized, Open Label Study Evaluating the Effect on Renal Function of Intravenous Bonviva Given by Injection or Infusion, Compared With Oral Alendronate, in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease.

This 3 arm study will evaluate renal safety after administration of an intravenous (iv) injection or infusion of Bonviva, compared to oral alendronate, in patients with postmenopausal osteoporosis, at increased risk of renal disease. Patients will be randomized to receive Bonviva 3mg intravenous (iv) by a) injection or b) infusion once every 3 months, or alendronate 70mg per oral (po) weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
801

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1425AGC
      • Buenos Aires, Argentina, B1878DVB
      • Buenos Aires, Argentina, C1012-CFed
      • Buenos Aires, Argentina, C1117ABH
      • Buenos Aires, Argentina, C1128AAF
      • Buenos Aires, Argentina, C1405BCH
      • Buenos Aires, Argentina, C1425 AWC
      • Cordoba, Argentina, X5000BNB
      • Santa Fe, Argentina, 2000
  • Brazil
      • Brasilia, Brazil, 71625-009
      • Curitiba, Brazil, 80030-110
      • Goiania, Brazil, 74110-120
      • Porto Alegre, Brazil, 90610-000
      • Rio de Janeiro, Brazil, 22271-100
      • Sao Paulo, Brazil, 04266-010
      • Vitoria, Brazil, 29055-450
  • Mexico
      • Guadalajara, Mexico, 44629
      • Mexico City, Mexico, 11000
      • Monterrey, Mexico, 64460
      • Obregon, Mexico, 85000
      • San Jerónimo Chicahualco, Mexico, 52170
  • South Africa
      • Durban, South Africa, 3630
      • Johannesburg, South Africa, 2196
      • Parow, South Africa, 7500
      • Port Elizabeth, South Africa, 6001
      • Somerset West, South Africa, 7130
  • Switzerland
      • Basel, Switzerland, 4055
      • Bern, Switzerland, 3010
      • Zurich, Switzerland, 8091
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
    • California
      • Riverside, California, United States, 92505
    • Colorado
      • Lakewood, Colorado, United States, 80227
    • Florida
      • West Palm Beach, Florida, United States, 33401
    • Georgia
      • Gainesville, Georgia, United States, 30501
    • Kansas
      • Topeka, Kansas, United States, 66604
    • Maryland
      • Bethesda, Maryland, United States, 20817
    • Nebraska
      • Omaha, Nebraska, United States, 68131
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
    • North Carolina
      • Morehead City, North Carolina, United States, 28557
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
      • Fargo, North Dakota, United States, 58103
    • Ohio
      • Cincinnati, Ohio, United States, 45224
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
    • Virginia
      • Norfolk, Virginia, United States, 23502

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • female patients, >=60 years of age;
  • >=5 years postmenopausal;
  • confirmed osteoporosis, at increased risk for renal disease.

Exclusion Criteria:

  • inability to stand or sit upright for 30 minutes;
  • hypersensitivity to bisphosphonates;
  • malignant disease (other than successfully resected basal cell cancer) within previous 10 years, or breast cancer diagnosed within previous 20 years;
  • previous administration of an i.v. bisphosphonate;
  • oral bisphosphonate treatment other than study medication within 30 days prior to the baseline dosing visit and during the study;
  • history of major upper gastrointestinal disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1
Drug: ibandronate [Bonviva/Boniva]
3mg intravenous (iv) injection every 3 months
Drug: ibandronate [Bonviva/Boniva]
3mg intravenous (iv) infusion every 3 months
Experimental: 2
Drug: ibandronate [Bonviva/Boniva]
3mg intravenous (iv) injection every 3 months
Drug: ibandronate [Bonviva/Boniva]
3mg intravenous (iv) infusion every 3 months
Active Comparator: 3
Drug: Alendronate
70mg per oral (po) weekly

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula)
Time Frame: Baseline and 9 months
The primary parameter of the study was the change (mL/min) from baseline in actual GFR (abbreviated MDRD formula using the patients' actual body surface area) after 9 months (or 40 weeks) of treatment.
Baseline and 9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Absolute Change From Baseline in Actual GFR (Using Cockcroft-Gault [CG] Formula)
Time Frame: Baseline and 9 months
Change (mL/min) from baseline in actual GFR (using Cockcroft-Gault [CG] formula) after 9 months (or 40 weeks) of treatment.
Baseline and 9 months
Relative Change From Baseline in Actual GFR (Using Abbreviated MDRD Formula)
Time Frame: Baseline and 9 months
Change (mL/min) from baseline in actual GFR (abbreviated MDRD formula using the patient's actual body surface area) after 9 months (or 40 weeks) of treatment.
Baseline and 9 months
Relative Change From Baseline in Actual GFR (Using CG Formula)
Time Frame: Baseline and 9 months
Change (mL/min) from baseline in actual GFR (CG formula using the patient's actual body surface area) after 9 months (or 40 weeks) of treatment.
Baseline and 9 months
Absolute Change From Baseline in Mean Serum Creatinine.
Time Frame: Baseline and 9 months
Baseline and 9 months
Relative Change From Baseline in Mean Serum Creatinine.
Time Frame: Baseline and 9 months
Baseline and 9 months
Absolute Change From Baseline in Urine Albumin-to-Creatinine Ratio.
Time Frame: Baseline and 9 months
Baseline and 9 months
Relative Change From Baseline in Urine Albumin-to-Creatinine Ratio.
Time Frame: Baseline and 9 months
The relative change from baseline in this case is positively skewed (while the absolute change is not) and the means tends to more positive values.
Baseline and 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BA20341

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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