BONCURE Study: A Study of Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis on Bisphosphonate Therapy. - Full Text View

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00545779

Purpose

This single arm study will assess patient preference for monthly Bonviva, versus daily or weekly alendronate or risedronate, in the treatment of postmenopausal osteoporosis. Patients currently on a daily or weekly regimen of bisphosphonate therapy (alendronate or risedronate) will answer a questionnaire to identify patients who may benefit from a monthly Bonviva regimen. Eligible patients will then discontinue their present bisphosphonate treatment, and switch to monthly Bonviva 150mg po. At the beginning and end of Bonviva treatment, all patients will complete an Osteoporosis Patient Satisfaction Questionnaire. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	'An Open-label Study of Patient Preference With Monthly Bonviva Therapy in Women With Post-menopausal Osteoporosis Switched From Daily or Weekly Alendronate or Risendronate.'

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:

Number and percentage of patients who prefer monthly Bonviva, compared with previous daily or weekly alendronate or risedronate [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Improved satisfaction scores with Bonviva [ Time Frame: 6 months ] [ Designated as safety issue: No ]
>=80% compliance with Bonviva [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Choice of monthly reminders to take Bonviva [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Improvement in GI symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment:	655
Study Completion Date:	July 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: ibandronate [Bonviva/Boniva] 150mg po monthly for 6 months

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

post-menopausal women;
>=3 months daily or weekly alendronate or risedronate for treatment or prevention of post-menopausal osteoporosis.

Exclusion Criteria:

inability to stand or sit in an upright position for at least 60 minutes;
hypersensitivity to bisphosphonates;
treatment with other drugs affecting bone metabolism;
abnormalities of the oesophagus, which delay oesophageal emptying.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00545779

Locations

Albania

Tirana, Albania
Bosnia and Herzegovina

Banja Luka, Bosnia and Herzegovina, 78000

Sarajevo, Bosnia and Herzegovina, 71000

Sarajevo, Bosnia and Herzegovina, 71 000

Tuzla, Bosnia and Herzegovina, 75000
Croatia

Rijeka, Croatia, 51000

Slavonski Brod, Croatia, 35000

Split, Croatia, 21000

Zagreb, Croatia, 10000
Macedonia, The Former Yugoslav Republic of

Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Serbia

Belgrade, Serbia, 11000

Niska Banja, Serbia, 18250

Novi Sad, Serbia, 21000
Turkey

Adana, Turkey, 01330

Ankara, Turkey, 06550

Ankara, Turkey, 06100

Antalya, Turkey, 07070

Aydin, Turkey, 09100

Bursa, Turkey, 16059

Denizli, Turkey, 20020

Erzurum, Turkey, 25240

Gaziantep, Turkey, 27310

Istanbul, Turkey, 35340

Istanbul, Turkey, 34300

Istanbul, Turkey, 34303

Istanbul, Turkey, 81190

Izmir, Turkey, 35100

Kayseri, Turkey, 38039

Konya, Turkey, 42080

Manisa, Turkey, 45200

Samsun, Turkey, 55139

Trabzon, Turkey, 61080

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00545779 History of Changes
Other Study ID Numbers:	ML20430
Study First Received:	October 16, 2007
Last Updated:	February 15, 2011
Health Authority:	Turkey: Ministry of Health

Additional relevant MeSH terms:

Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

Ibandronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 13, 2012