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Completed

NCT Number: NCT00545051

A Study of Once Monthly Bonviva (Ibandronate) in Prevention of Glucocorticoid-Induced Osteoporosis.

This 2 arm study will investigate the efficacy and safety of Bonviva (150mg po monthly) in the prevention of glucocorticoid-induced osteoporosis in post-menopausal women. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, with vitamin D and calcium supplementation. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

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Key information

Conditions

Postmenopausal Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Age range

50 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Helsinki, Finland

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • post-menopausal women, 50-85 years of age;
  • any inflammatory rheumatoid disease including polymyalgia rheumatica;
  • receiving treatment with 5-15 mg/day of prednisolone.

Exclusion criteria

  • previous treatment with an iv bisphosphonate at any time;
  • previous treatment with an oral bisphosphonate within the last 6 months, >1 month of treatment within last year, or >3 months of treatment within last 2 years;
  • treatment with parathyroid hormone in last 2 years;
  • inability to stand or sit in an upright position for at least 60 minutes;
  • inability to swallow a tablet whole;
  • history of major gastrointestinal disease.

Treatment and study plan

Placebo

Drug

po monthly for 12 months

Ibandronate

Drug

150mg po monthly for 12 months

Other names: Bonviva/Boniva

Primary outcomes

  1. Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12

    Time frame: Baseline and Month 12

    Lumbar spine BMD was measured at Baseline, and Months 6 and 12 using dual-energy x-ray absorptiometry (DXA). Percent change from Baseline to Month 12 was calculated using analysis of covariance.

Secondary outcomes

  1. Percent Change From Baseline in Mean Lumbar Spine BMD at Month 6

    Time frame: Baseline and Month 6

    Lumbar spine BMD was measured at Baseline and Month 6 using DXA. Percent change from Baseline to Month 6 was calculated using analysis of covariance.

  2. Percent Change From Baseline in Mean Total Hip BMD at Month 6 and Month 12

    Time frame: Baseline and Months 6 and 12

    Left total hip BMD was measured by DXA at Baseline, and Months 6 and 12. If there was prosthesis of left hip, the measurement of right total hip BMD was done by DXA. Percent change from Baseline to Months 6 and 12 was calculated using analysis of (co)variance for repeated measurements.

  3. Percent Change From Baseline in Bone Turnover Markers at Month 1, Month 6 and Month 12

    Time frame: Baseline and Months 1, 6 and 12

    Serum C-terminal Telopeptide of Type 1 Collagen (sCTX), Serum Procollagen Type 1 N-terminal Propeptide (P1NP) and Serum Bone Tartrate-resistant Acid Phosphatase Isoform 5b (TRACP) are measures of bone resorption and are measured as nanograms per milliliter (ng/mL). Percent change from Baseline to Months 1, 6 and 12 was calculated using analysis of covariance for repeated measurements.

  4. Percentage of Participants Withdrawn Due to Worsening in BMD at 6 Months and/or Worsening in BMD at Least 7 Percent (%) at Any Site at 6 Months

    Time frame: Month 6

    Worsening in BMD was defined as BMD T-score at any site less than or equal to (≤) - 2.5 standard deviations and/or worsening in BMD of at least 7% at any site.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

A Randomized, Double-blind Study to Evaluate the Effect of Once Monthly Bonviva on Lumbar Bone Mineral Density in the Prevention of Glucocorticoid-induced Osteoporosis in Post-menopausal Women

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Oct 17, 2007
Registry last updated
May 12, 2016

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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