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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: November 2007

Interventions

  • Drug: ibandronate [Bonviva/Boniva]
    • 150mg po monthly for 3 years
  • Drug: ibandronate [Bonviva/Boniva]
    • 100mg po monthly for 3 years

Arms, Groups and Cohorts

  • Experimental: 1
  • Active Comparator: 2

Clinical Trial Outcome Measures

Primary Measures

  • 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]).

Secondary Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hoffmann-La Roche
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clinical Trials, Study Director, Hoffmann-La Roche

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.