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A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Who Have Received Previous Bonviva Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00551174
Recruitment Status : Completed
First Posted : October 30, 2007
Results First Posted : May 30, 2011
Last Update Posted : July 22, 2011
Sponsor:
Information provided by:
Hoffmann-La Roche

Brief Summary:
This 2-arm study was designed to assess the long-term safety and tolerability of intravenous (IV) treatment with 2 mg or 3 mg Bonviva in women with post-menopausal osteoporosis who had previously completed Bonviva study BM16550 (DIVA study; NCT00048074). Patients received Bonviva either 2 mg IV every 2 months, or 3 mg IV every 3 months. Patients also received daily supplementation with vitamin D and calcium. The anticipated time on study treatment was 2+ years, and the target sample size was 500+ individuals.

Condition or disease Intervention/treatment Phase
Post-Menopausal Osteoporosis Drug: ibandronate [Bonviva/Boniva] Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 781 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label, Parallel Group, Multicenter Study of Two Intravenous (IV) Ibandronate Dose Regimens (2 mg Every 2 Months and 3 mg Every 3 Months) in Women With Postmenopausal Osteoporosis Who Completed Trial BM16550
Study Start Date : October 2004
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1 Drug: ibandronate [Bonviva/Boniva]
3 mg IV every 3 months for 3 years. All patients received a minimum of calcium 500 milligrams/day (upper limit 1500 mg/day) and Vitamin D 400 Internation Units/day (IU/day).

Active Comparator: 2 Drug: ibandronate [Bonviva/Boniva]
2 mg IV every 2 months for 3 years. All patients received a minimum of calcium 500 milligrams/day (upper limit 1500 mg/day) and Vitamin D 400 Internation Units/day (IU/day).




Primary Outcome Measures :
  1. Relative Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at 12, 24 and 36 Months [ Time Frame: Baseline,12, 24 and 36 months ]
    Relative change percent(%) from baseline of MA17904 and BM16550 (NCT00048074) in mean lumbar spine (L2-L4) BMD at 12, 24 and 36 months (i.e., 3, 4 and 5 years after initiation of BM16550)- Study MA17940.Percent change=[(measure at time t - measure at baseline)/measure at baseline]*100%, where t=12, 24 and 36 months. The baseline value is used as a reference to calculate the relative change from baseline.


Secondary Outcome Measures :
  1. Relative Percent Change From Baseline in Mean Total Hip BMD at 12, 24 and 36 Months [ Time Frame: Baseline,12, 24 and 36 months ]
    Relative change percent (%) from baseline of MA17904 and BM16550 (NCT00048074) in mean total hip BMD at 12, 24 and 36 months (i.e., 3, 4 and 5 years after initiation of BM16550)- Study MA17904. Percent change=[(measure at time t - measure at baseline)/measure at baseline]*100%, where t=12, 24 and 36 months. The baseline value is used as a reference to calculate the relative change from baseline.

  2. Relative Percent Change From Baseline in Serum C-telopeptide Crosslinks of Type I Collagen (CTX) at Trough at 6, 12, 24 and 36 Months [ Time Frame: Baseline, 6, 12, 24 and 36 months (i.e., 2.5, 3, 4 and 5 years after initiation of BM16550) ]
    Relative percent (%) change from baseline of MA17904 and BM16550 (NCT00048074) in serum C-telopeptide crosslinks of type I collagen (CTX) at trough at 6, 12, 24 and 36 months- Study MA17904. Percent change=[(measure at time t - measure at baseline)/measure at baseline]*100%, where t=6, 12, 24 and 36 months. The baseline value is used as a reference to calculate the relative change from baseline.

  3. Relative Percent Change From Baseline in Post-dose Suppression of Serum CTX at 6 Months [ Time Frame: Baseline, 6 months ]
    Relative percent (%) change from MA17904 baseline of post-dose suppression of serum C-telopeptide crosslinks of type I collagen (CTX) at 6 months- Study MA17904. Percent change=[(measure at time t - measure at baseline)/measure at baseline]*100%, where t= 6 months. The baseline value is used as a reference to calculate the relative change from baseline.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Successful completion of Bonviva study BM16550 (NCT00048074), with at least 75% compliance
  • Ambulatory

Exclusion Criteria:

  • Patients who completed the Bonviva study BM16550 (NCT00048074) >3 months before the planned start date for this study
  • Malignant disease diagnosed since inclusion into previous study
  • Treatment with drugs affecting bone metabolism since inclusion into previous study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00551174


Locations
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United States, Georgia
Gainesville, Georgia, United States, 30501
United States, Missouri
St Louis, Missouri, United States, 63110
United States, Nebraska
Omaha, Nebraska, United States, 68131
United States, North Dakota
Bismarck, North Dakota, United States, 58501
Fargo, North Dakota, United States, 58103
United States, Wisconsin
Madison, Wisconsin, United States, 53792
Australia
St. Leonards, Australia, 2139
Sydney, Australia, 3129
Belgium
Bruxelles, Belgium, 1180
Liege, Belgium, 4020
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, 69000
Orleans, France, 45032
Germany
Berlin, Germany, 12200
Essen, Germany, 45276
Hamburg, Germany, 20354
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, 30-510
Krakow, Poland, 31-501
South Africa
Cape Town, South Africa, 7500
Pretoria, South Africa
Sommerset West, South Africa, 7129
Spain
Madrid, Spain, 28046
United Kingdom
Aberdeen, United Kingdom, AB25 2ZD
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
Additional Information:
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Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00551174    
Other Study ID Numbers: MA17904
First Posted: October 30, 2007    Key Record Dates
Results First Posted: May 30, 2011
Last Update Posted: July 22, 2011
Last Verified: July 2011
Additional relevant MeSH terms:
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Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Ibandronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs