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: July 7, 2014
Last verified: July 2014
  Purpose

This 2 arm study will investigate the efficacy and safety of Bonviva (150mg po m onthly) in the prevention of glucocorticoid-induced osteoporosis in post-menopau sal women. Patients will be randomized to receive either Bonviva 150mg po or pla cebo monthly, with vitamin D and calcium supplementation. The anticipated time o n study treatment is 1-2 years, and the target sample size is 100-500 individual s.


Condition Intervention Phase
Post-Menopausal Osteoporosis
Drug: ibandronate [Bonviva/Boniva]
Drug: Placebo
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:
  • Percentage change from baseline in mean lumbar spine (L1-L4) BMD [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in mean lumbar spine BMD [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in total hip BMD [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Change in bone turnover markers [ Time Frame: 1, 6 and 12 months ] [ Designated as safety issue: No ]
  • Withdrawal rates due to worsening BMD [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • AEs, clinical fractures, laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

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: 1 Drug: ibandronate [Bonviva/Boniva]
150mg po monthly for 12 months
Placebo Comparator: 2 Drug: Placebo
po monthly for 12 months

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
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, 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, 90029
Oulu, Finland, 90100
Tampere, Finland, 33101
Tampere, Finland, 33100
Turku, Finland, 20100
Vantaa, Finland, 01300
Sponsors and Collaborators
Hoffmann-La Roche
GlaxoSmithKline
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00545051     History of Changes
Other Study ID Numbers: ML20088
Study First Received: October 16, 2007
Last Updated: July 7, 2014
Health Authority: Finland: Ministry of Social Affairs and Health/ETENE

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

ClinicalTrials.gov processed this record on July 24, 2014