DIVA Study - A Study of Different Regimens of Intravenous Administration of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis

January 4, 2016 updated by: Hoffmann-La Roche

A Randomized, Double-blind Study Comparing the Effect of Different Treatment Regimens of Intravenous Bonviva on Lumbar Bone Mineral Density in Women With Osteoporosis

This study will assess the efficacy and safety of intravenous administration of Bonviva regimens in women with post-menopausal osteoporosis, compared to oral daily administration. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, 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.
1395

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 3

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

  • Australia
      • Darlinghurst, Australia, 2010
      • Melbourne, Australia, 3084
      • Nedlands, Australia, 6000
      • St. Leonards, Australia, 2139
      • Sydney, Australia, 3129
  • Belgium
      • Bruxelles, Belgium, 1180
      • Liege, Belgium, 4020
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5C 2T2
    • Quebec
      • Laval, Quebec, Canada, H7T 2P5
      • Montreal, Quebec, Canada, H3A 1A1
      • Montreal, Quebec, Canada, H2X 3J4
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 0H6
  • Czech Republic
      • Plzen, Czech Republic, 305 99
      • Praha, Czech Republic, 128 00
  • Denmark
      • Aalborg, Denmark, 9000
      • Ballerup, Denmark, 2750
      • København, Denmark, 1399
      • Vejle, Denmark, 7100
      • Århus, Denmark, 8000
  • France
      • Lyon, France, 69437
      • Orleans, France, 45000
  • Germany
      • Berlin, Germany, 12200
      • Bochum, Germany, 44789
      • Hamburg, Germany, 20246
  • Hungary
      • Budapest, Hungary, 1036
  • Italy
      • Arenzano, Italy, 16011
      • Siena, Italy, 53100
      • Valeggio Sul Mincio, Italy, 37067
  • Mexico
      • Mexico City, Mexico, 11000
      • Monterrey, Mexico, 64460
  • Norway
      • Haugesund, Norway, 5507
      • Oslo, Norway, 0176
      • Stavanger, Norway, 4010
  • Poland
      • Grudziadz, Poland, 86-300
      • Krakow, Poland, 31-501
      • Krakow, Poland, 30-510
  • South Africa
      • Cape Town, South Africa, 7500
      • Pretoria, South Africa
      • Sommerset West, South Africa, 7129
  • Spain
      • Barcelona, Spain, 08003
      • Madrid, Spain, 28046
      • Santander, Spain, 39008
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 1LD
      • Manchester, United Kingdom, M13 9WL
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205-7199
    • California
      • Irvine, California, United States, 92618
      • Rancho Mirage, California, United States, 92270
    • Florida
      • Leesburg, Florida, United States, 34748
    • Georgia
      • Gainesville, Georgia, United States, 30501
    • Idaho
      • Coeur D'alene, Idaho, United States, 83814
    • Maryland
      • Bethesda, Maryland, United States, 20817
    • Missouri
      • St Louis, Missouri, United States, 63110
    • Montana
      • Billings, Montana, United States, 59120
    • Nebraska
      • Omaha, Nebraska, United States, 68131
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
    • New York
      • New York, New York, United States, 10029
    • North Dakota
      • Bismarck, North Dakota, United States, 58503
      • Fargo, North Dakota, United States, 58103
    • Pennsylvania
      • Wyomissing, Pennsylvania, United States, 19610
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
    • Texas
      • San Antonio, Texas, United States, 78229
    • Virginia
      • Virginia Beach, Virginia, United States, 23462
    • Wisconsin
      • Madison, Wisconsin, United States, 53792

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

55 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • women 55-80 years of age;
  • post-menopausal for >=5 years;
  • ambulatory.

Exclusion Criteria:

  • malignant disease diagnosed within the previous 10 years (except basal cell cancer that has been successfully removed);
  • breast cancer within the previous 20 years;
  • allergy to bisphosphonates;
  • previous treatment with an intravenous bisphosphonate at any time;
  • previous treatment with an oral bisphosphonate within the last 6 months, >1 month of treatment within the last year, or >3 months of treatment within the last 2 years.

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: Double

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
oral placebo daily and IV ibandronate 2 mg q 2 mo
Drug: ibandronate [Bonviva/Boniva]
3mg iv every 3 months
Drug: ibandronate [Bonviva/Boniva]
2mg iv every 2 months
Drug: ibandronate [Bonviva/Boniva]
2.5mg po daily
Experimental: 2
oral ibandronate 2.5 mg daily and IV placebo q 2 mo and q 3 mo
Drug: ibandronate [Bonviva/Boniva]
3mg iv every 3 months
Drug: ibandronate [Bonviva/Boniva]
2mg iv every 2 months
Drug: ibandronate [Bonviva/Boniva]
2.5mg po daily
Experimental: 3
oral placebo daily and IV ibandronate 3 mg q 3 mo
Drug: ibandronate [Bonviva/Boniva]
3mg iv every 3 months
Drug: ibandronate [Bonviva/Boniva]
2mg iv every 2 months
Drug: ibandronate [Bonviva/Boniva]
2.5mg po daily

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
Relative Percent Change From Baseline in Mean Bone Mineral Density (BMD) of Lumbar Spine (L2-L4) at 12 Months
Time Frame: Baseline and Month 12
BMD was measured by a single dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine at the time of screening and at Month 12. The change in BMD was defined as the relative difference between the last individual measurement available at 12 months and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year - BMD at Baseline) / (BMD at Baseline)
Baseline and Month 12

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
Relative Percent Change From Baseline in Mean BMD of Lumbar Spine (L2-L4) at 24 Months
Time Frame: Baseline and Month 24
BMD was measured by a single dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine at the time of screening and at Month 24. The change in BMD was defined as the relative difference between the last individual measurement available at 24 months and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year - BMD at Baseline) / (BMD at Baseline)
Baseline and Month 24
Absolute Change From Baseline in Mean BMD of Lumbar Spine (L2 - L4) at Month 12 and Month 24
Time Frame: Baseline, Month 12 and Month 24
BMD was measured by a single dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine at screening, Month 12 and Month 24. The absolute change from Baseline in mean BMD of the lumbar spine (L2-L4) was defined as the difference between the last individual measurement available at Month 12 or Month 24 and Baseline. Only participants with data available at particular timepoint were analyzed.
Baseline, Month 12 and Month 24
Relative Percent Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24
Time Frame: Baseline, Month 12 and Month 24
BMD was measured by a single DXA scan of the proximal femur at the time of screening, Month 12 and Month 24.The change in BMD of the proximal femur (total hip, trochanter, femoral neck) was defined as the relative difference between the last individual measurement available at Month 12 or Month 24and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year/2year - BMD at Baseline) / (BMD at Baseline). BMD of fractured bones that could impact the scan area were not taken into account. Only participants with data available at particular timepoint were analyzed.
Baseline, Month 12 and Month 24
Absolute Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24
Time Frame: Baseline, Month 12 and Month 24
BMD was measured by a single DXA scan of the proximal femur at the time of screening, Month 12 and Month 24. The absolute change in BMD was defined as the difference between the last individual measurement available at Month 12 or Month 24 and Baseline. BMD of fractured bones that could impact the scan area were not taken into account. Only participants with data available at particular timepoint were analyzed.
Baseline, Month 12 and Month 24
Relative Change From Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen (CTX) at Month 6, 12, and 24
Time Frame: Baseline, At Month 6, 12, and 24.
Serum CTX, a biochemical marker of bone resorption, was measured using the Elecsys s-CTX-I assay, an electrochemiluminescence immunoassay (ECLIA) technique. Samples for serum CTX measurements were collected from participants immediately prior to their IV dosing. Thus, the values reported here represent trough or residual values taken at the end of the 2 month or 3 month IV dosing interval. The change in serum CTX was defined as the relative difference between the last individual measurement available at Month 6 or Month 12 or Month 24 and Baseline, using the following formula: Relative change = 100 x (CTX at Month 6/Month 12/Month 24- CTX at Baseline) / (CTX at Baseline). Only participants with data available at particular timepoint were analyzed.
Baseline, At Month 6, 12, and 24.
Absolute Change From Baseline in Serum CTX at Month 6, 12, and 24
Time Frame: Baseline, At Month 6, 12, and 24.
Serum CTX, a biochemical marker of bone resorption, was measured using the Elecsys s-CTX-I assay, an electrochemiluminescence immunoassay (ECLIA) technique. Samples for serum CTX measurements were collected from participants immediately prior to their IV dosing. Thus, the values reported here represent trough or residual values taken at the end of the 2 month or 3 month IV dosing interval. The absolute change from Baseline in serum CTX was defined as the difference between the last individual measurement available at Month 6 or Month 12 or Month 24 and Baseline. Only participants with data available at particular timepoint were analyzed.
Baseline, At Month 6, 12, and 24.
Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Month 12 and 24
Time Frame: At Month 12 and 24
A participant is a responder if the mean lumber spine (L2 - L4) BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.
At Month 12 and 24
Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Month 12 and 24
Time Frame: At Month 12 and 24
A participant is a responder if the mean total hip BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.
At Month 12 and 24
Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Month 12 and 24
Time Frame: At Month 12 and 24
A participant is a responder if the mean trochanter BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.
At Month 12 and 24
Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Month 12 and 24
Time Frame: At Month 12 and 24
A participant is a responder if the mean femoral neck BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.
At Month 12 and 24
Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24
Time Frame: At Month 12 and 24
A participant is a responder if the mean total hip and mean lumbar spine BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.
At Month 12 and 24
Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24
Time Frame: At Month 12 and 24
A participant is a responder if the mean trochanter and lumbar spine BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.
At Month 12 and 24
Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24
Time Frame: At Month 12 and 24
A participant is a responder if the mean femoral neck and lumbar spine BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.
At Month 12 and 24
Number of Participants Who Experienced Any Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time Frame: Approximately 2 years
An AE is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
Approximately 2 years
Number of Participants With Any Marked Abnormality in Laboratory Parameters
Time Frame: Approximately 2 years
Marked laboratory test value abnormalities (high and low) are those which exceed the marked reference range (i.e., a reference range greater than the standard reference range) and which also represents a clinically relevant change from baseline of at least a designated amount. The indicated abnormal laboratory parameters (along with their marked reference range) are as follows: low and high Hematocrit (0.36 - 0.60 fraction), low and high hemoglobin (11.0 - 20.0 g/dL), low and high platelets (100 - 700 * 10^9/L), low and high white blood cell (WBC) (3.0 - 18.0 * 10^9/L), high alanine aminotransferase (ALAT) (0 - 60 U/L), high blood urea nitrogen (BUN) (0 - 14.3 mmol/L) , high creatinine (0 - 154 mmol/L), low albumin (27.0 - 48.0 g/L), low and high chloride (95 - 115 mmol/L), low potassium (3.0 - 6.0 mmol/L), low sodium (130 - 150 mmol/L), high calcium (2.00 - 2.90 mmol/L), low and high phosphate (0.75 - 1.60 mmol/L).
Approximately 2 years

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.
June 1, 2002

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.
May 1, 2005

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.
May 1, 2005

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).
October 24, 2002

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.
October 24, 2002

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.
October 25, 2002

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.
February 3, 2016

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.
January 4, 2016

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.
January 1, 2016

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.
  • BM16550

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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