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:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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 ]

Estimated Enrollment:	650
Study Start Date:	December 2006
Estimated Study Completion Date:	October 2008

Arms	Assigned Interventions
1: Experimental	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

SARAJEVO, Bosnia and Herzegovina, 71000

TUZLA, Bosnia and Herzegovina, 75000

BANJA LUKA, Bosnia and Herzegovina, 78000

SARAJEVO, Bosnia and Herzegovina, 71 000
Croatia

ZAGREB, Croatia, 10000

RIJEKA, Croatia, 51000

SPLIT, Croatia, 21000

SLAVONSKI BROD, Croatia, 35000
Macedonia, The Former Yugoslav Republic of

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

NOVI SAD, Serbia, 21000

NISKA BANJA, Serbia, 18250

BELGRADE, Serbia, 11000
Turkey

BURSA, Turkey, 16059

ISTANBUL, Turkey, 34300

ISTANBUL, Turkey, 34303

KAYSERI, Turkey, 38039

IZMIR, Turkey, 35100

ISTANBUL, Turkey, 35340

ANTALYA, Turkey, 07070

ADANA, Turkey, 01330

KONYA, Turkey, 42080

AYDIN, Turkey, 09100

TRABZON, Turkey, 61080

DENIZLI, Turkey, 20020

ERZURUM, Turkey, 25240

ANKARA, Turkey, 06550

GAZIANTEP, Turkey, 27310

ANKARA, Turkey, 06100

SAMSUN, Turkey, 55139

MANISA, Turkey, 45200

ISTANBUL, Turkey, 81190

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML20430
Study First Received:	October 16, 2007
Last Updated:	September 16, 2009
ClinicalTrials.gov Identifier:	NCT00545779 History of Changes
Health Authority:	Turkey: Ministry of Health

Additional relevant MeSH terms:

Ibandronic acid
Musculoskeletal Diseases
Physiological Effects of Drugs
Osteoporosis, Postmenopausal
Osteoporosis

Bone Density Conservation Agents
Bone Diseases, Metabolic
Bone Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 25, 2009