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

Sponsor:	Hoffmann-La Roche
Collaborator:	GlaxoSmithKline
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00545051

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
Post-Menopausal Osteoporosis	Drug: ibandronate [Bonviva/Boniva] Drug: Placebo	Phase IV

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:

MedlinePlus related topics: Menopause Osteoporosis

Drug Information available for: Ibandronic acid Ibandronate sodium

U.S. FDA Resources

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 Completion Date:	May 2009

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

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, 40100

Jyvaeskylae, Finland, 10100

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:	Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00545051 History of Changes
Other Study ID Numbers:	ML20088
Study First Received:	October 16, 2007
Last Updated:	December 15, 2009
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 February 09, 2012