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

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

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.

Study Overview

• Status: Completed
• Conditions: Postmenopausal Osteoporosis
• Intervention / Treatment: Drug: ibandronate; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 4

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00290
  • Helsinki, Finland, 00100
  • Helsinki, Finland, 00350
  • Hyvinkää, Finland, 05800
  • Hämeenlinna, Finland, 13530
  • Jyvaeskylae, Finland, 10100
  • Jyväskylä, Finland, 40100
  • Kuopio, Finland, 70211
  • Lahti, Finland, 15110
  • Oulu, Finland, 90100
  • Oulu, Finland, 90029
  • Tampere, Finland, 33101
  • Tampere, Finland, 33100
  • Turku, Finland, 20100
  • Vantaa, Finland, 01300

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ibandronate; Participants received monthly oral ibandronate (150 milligrams [mg]) for 12 months.	Drug: ibandronate; 150mg po monthly for 12 months; Other Names: Bonviva/Boniva
Placebo Comparator: Placebo; Participants received monthly oral placebo for 12 months.	Drug: Placebo; po monthly for 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at 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.	Baseline and Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in Mean Lumbar Spine BMD at 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.	Baseline and Month 6
Percent Change From Baseline in Mean Total Hip BMD at Month 6 and Month 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.	Baseline and Months 6 and 12
Percent Change From Baseline in Bone Turnover Markers at Month 1, Month 6 and Month 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.	Baseline and Months 1, 6 and 12
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	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.	Month 6

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Collaborators: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: October 16, 2007
• First Submitted That Met QC Criteria: October 16, 2007
• First Posted (Estimate): October 17, 2007

Study Record Updates

• Last Update Posted (Estimate): May 12, 2016
• Last Update Submitted That Met QC Criteria: April 5, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Osteoporosis, Postmenopausal; Physiological Effects of Drugs; Bone Density Conservation Agents; Ibandronic Acid
• Other Study ID Numbers: ML20088