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Completed

NCT Number: NCT00081653

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

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.

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Key information

Conditions

Post-Menopausal Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Liège, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ibandronate [Bonviva/Boniva]

Drug

150mg po monthly for 3 years

Primary outcomes

  1. 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]).

  2. 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 outcomes

  1. 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).

  2. 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).

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2007
Study completion
2008
First posted
Apr 21, 2004
Registry last updated
Jul 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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