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A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Previously Treated With Bonviva

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ClinicalTrials.gov Identifier: NCT00081653
Recruitment Status : Completed
First Posted : April 21, 2004
Results First Posted : July 21, 2009
Last Update Posted : July 14, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE April 19, 2004
First Posted Date  ICMJE April 21, 2004
Results First Submitted Date  ICMJE December 22, 2008
Results First Posted Date  ICMJE July 21, 2009
Last Update Posted Date July 14, 2017
Study Start Date  ICMJE May 2004
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2015)
  • Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD [ Time Frame: Baseline and Months 12, 24 and 36 ]
    Absolute change from Baseline in mean BMD of the lumbar spine (L2 - L4) measured as grams per square centimeter (g/cm^2). This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 [NCT00081653]).
  • Relative Percent (%) Change From Baseline in Mean Lumbar Spine (L2 - L4) Bone Mineral Density (BMD) [ Time Frame: Baseline and Months 12, 24 and 36 ]
    BMD was measured by a single dual-energy X-ray absorptiometry (DXA) scan of the lumbar spine (BMD of at least 2 vertebrae [L2-L4] that were not fractured and not affected by osteoarthritis to such a degree that BMD measurement would be compromised) at the time of enrollment and at Months 12, 24 and 36. This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 [NCT00081653]).
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00081653 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2015)
  • Absolute Change From Baseline in Mean Total Hip BMD [ Time Frame: Baseline and 12, 24 and 36 months ]
    BMD was measured by a single DXA scan of the hip. Scores between -1 and -2.5 indicate Osteopenia (thin bones). Less than -2.5 indicate Osteoporosis (porous bones).
  • Relative Percent Change From Baseline in Mean Total Hip BMD [ Time Frame: Baseline, 12, 24 and 36 months ]
    BMD was measured by a single DXA scan of the hip. Scores between -1 and -2.5 indicate Osteopenia (thin bones). Less than -2.5 indicate Osteoporosis (porous bones).
  • Absolute Change From Baseline of Trough Serum CTX [ Time Frame: Baseline, 6, 12, 24 and 36 months ]
    CTX is a measure of bone resorption and is measured as ng/mL. Blood samples for the Month 6 values were collected 6 days after the 6-month dose; therefore, the Month 6 values are not true 'trough' values.
  • Relative Percent Change From Baseline of Trough Serum CTX [ Time Frame: Baseline, 6,12, 24 and 36 months ]
    CTX is a measure of bone resorption and is measured as nanograms per milliliter (ng/mL). Blood samples for the Month 6 values were collected 6 days after the 6-month dose; therefore, the Month 6 values are not true 'trough' values.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Previously Treated With Bonviva
Official Title  ICMJE Double-blind, Partially Randomized, Parallel Group, Multicenter Study to Assess the Efficacy and Safety of 100 mg and 150 mg Monthly Oral Ibandronate in Women With Postmenopausal Osteoporosis Having Completed the Phase III Oral Ibandronate Trial BM16549
Brief Summary This 2 arm study will assess the long-term efficacy and safety of oral treatment with 100mg or 150mg Bonviva in women with post-menopausal osteoporosis who have previously completed Bonviva study BM16549 (MOBILE study). Patients will receive Bonviva either 100mg po monthly, or 150mg po monthly. 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Post-Menopausal Osteoporosis
Intervention  ICMJE
  • Drug: ibandronate [Bonviva/Boniva]
    150mg po monthly for 3 years
  • Drug: ibandronate [Bonviva/Boniva]
    100mg po monthly for 3 years
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: ibandronate [Bonviva/Boniva]
  • Active Comparator: 2
    Intervention: Drug: ibandronate [Bonviva/Boniva]
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 18, 2008)
719
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2008
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • successful completion of Bonviva study BM16549, with at least 75% compliance;
  • ambulatory.

Exclusion Criteria:

  • malignant disease diagnosed within the previous 12 years (except basal cell cancer that has been successfully removed);
  • breast cancer diagnosed within the previous 22 years.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Brazil,   Czechia,   Denmark,   France,   Germany,   Hungary,   Italy,   Mexico,   Norway,   Poland,   Spain,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT00081653
Other Study ID Numbers  ICMJE MA17903
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP