Roche trials database

Trial information

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

Status:

Active, not recruiting

Protocol number:

ML25399

Sponsor:

Hoffmann-La Roche

Company division:

Pharmaceutical

Official Scientific Title:

Interventional, single arm, open label study of the efficacy, safety and compliance to the treatment with intravenous (IV) ibandronate (Bonviva®) in the postmenopausal osteoporosis treatment of bisphosphonates naïve patients in daily practice

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. Target sample size is 41.

Study phase:

III

Study type:

Interventional; Treatment; Non-randomized; Single group; Safety/efficacy study

Conditions:

• Post-Menopausal Osteoporosis

Intervention type:

Drug

Intervention name:

ibandronate [Bonviva/Boniva]

Primary outcome:

1. Efficacy: Mean change in lumbar spine and hip bone mineral density (BMD) from baseline Time frame: from baseline to Month 12 and 24

Key secondary outcomes:

1. Compliance: percentage of patients that have received all planned study medication Time frame: 3 years
2. Correlation of patient's profile parameters (age, year since menopause, fracture history, BMD at baseline) with compliance Time frame: 3 years
3. Safety: Incidence of adverse events Time frame: 3 years

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

Gender:

Females

Age limits:

Min: 50 years Max: N/A (No limit)

Accepts healthy volunteers:

No

Anticipated start date:

April, 2011

Trial registration date:

11.08.2010

Date last updated:

06.05.2013

This trial was conducted at the following locations:

Bosnia and Herzegovina

• BANJA LUKA
• SARAJEWO

Link to trial result