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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00545051
First received: October 16, 2007
Last updated: April 5, 2016
Last verified: April 2016
  Purpose
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.

Condition Intervention Phase
Postmenopausal Osteoporosis
Drug: Placebo
Drug: ibandronate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Percent Change From Baseline in Mean Lumbar Spine BMD at Month 6 [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    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.

  • Percent Change From Baseline in Mean Total Hip BMD at Month 6 and Month 12 [ Time Frame: Baseline and Months 6 and 12 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 140
Study Start Date: May 2006
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ibandronate
Participants received monthly oral ibandronate (150 milligrams [mg]) for 12 months.
Drug: ibandronate
150mg po monthly for 12 months
Other Name: Bonviva/Boniva
Placebo Comparator: Placebo
Participants received monthly oral placebo for 12 months.
Drug: Placebo
po monthly for 12 months

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00545051

Locations
Finland
Helsinki, Finland, 00100
Helsinki, Finland, 00290
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, 33100
Tampere, Finland, 33101
Turku, Finland, 20100
Vantaa, Finland, 01300
Sponsors and Collaborators
Hoffmann-La Roche
GlaxoSmithKline
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00545051     History of Changes
Other Study ID Numbers: ML20088 
Study First Received: October 16, 2007
Results First Received: April 5, 2016
Last Updated: April 5, 2016
Health Authority: Finland: Ministry of Social Affairs and Health/ETENE

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Ibandronic acid
Diphosphonates
Glucocorticoids
Bone Density Conservation Agents
Physiological Effects of Drugs
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on July 27, 2016