A Study of Bonviva/Boniva (Ibandronate) in Biphosphonate-Naïve Women With Post-Menopausal Osteoporosis

NCT ID: NCT01290094

Last Updated: 2015-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2014-07-31

Brief Summary

This single arm, open label study will assess the efficacy and safety of and compliance to treatment with Bonviva/Boniva (ibandronate) in biphosphonate-naïve patients with post-menopausal osteoporosis. Patients will receive Bonviva/Boniva at a dose of 3 mg intravenously every three months. Anticipated time on study treatment is 12 months with a follow-up of 12 months.

Conditions

Post Menopausal Osteoporosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Arm

Group Type: EXPERIMENTAL

ibandronate [Bonviva/Boniva]

Intervention Type: DRUG

3 mg intravenously every 3 months

Interventions

ibandronate [Bonviva/Boniva]

3 mg intravenously every 3 months

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Female patients, > 50 years of age
• Diagnosed osteoporosis
• Bone mineral density < minus 2.5 SD or osteoporotic fracture
• At least 3 years after menopause

Exclusion Criteria

• Impaired renal function
• Contra-indication to Calcium or Vitamin D therapy
• Previous or current treatment with biphosphonates

• Minimum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Banja Luka, , Bosnia and Herzegovina

Sarajevo, , Bosnia and Herzegovina

Countries

Bosnia and Herzegovina

Other Identifiers

ML25399

Identifier Type: -

Identifier Source: org_study_id