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

• ClinicalTrials.gov Identifier: NCT01290094
• Recruitment Status: Completed
• First Posted: February 4, 2011
• Results First Posted: August 13, 2015
• Last Update Posted: August 13, 2015
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Post Menopausal Osteoporosis	Drug: ibandronate [Bonviva/Boniva]	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 41 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official 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
• Study Start Date: April 2011
• Actual Primary Completion Date: July 2014
• Actual Study Completion Date: July 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: Single Arm	Drug: ibandronate [Bonviva/Boniva]; 3 mg intravenously every 3 months

Outcome Measures

Primary Outcome Measures :

1. Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12 [ Time Frame: Baseline, Month 12 ]
   Percent change was calculated as [(measure at time "t" minus [-] measure at baseline) divided by (/) measure at baseline] multiplied by (*) 100, where t=12 months. The baseline value is used as a reference to calculate the relative change from baseline.
2. Percent Change From Baseline in Mean Lumbar Spine BMD at Month 24 [ Time Frame: Baseline, Month 24 ]
   Percent change was calculated as [(measure at time "t" - measure at baseline)/measure at baseline]*100, where t=24 months. The baseline value is used as a reference to calculate the relative change from baseline.
3. Percent Change From Baseline in Mean Hip Bone BMD at Month 12 [ Time Frame: Baseline, Month 12 ]
   Percent change was calculated as [(measure at time "t" - measure at baseline)/measure at baseline]*100, where t=12 months. The baseline value is used as a reference to calculate the relative change from baseline.
4. Percent Change From Baseline in Mean Hip BMD at Month 24 [ Time Frame: Baseline, Month 24 ]
   Percent change was calculated as [(measure at time "t" - measure at baseline)/measure at baseline]*100, where t=24 months. The baseline value is used as a reference to calculate the relative change from baseline.

Secondary Outcome Measures :

1. Percent Change From Baseline in Lumbar Spine T-score at Month 12 and 24 [ Time Frame: Baseline, Month 12, Month 24 ]
   Percent change was calculated as [(measure at time "t" - measure at baseline)/measure at baseline]*100, where t=12 and 24 months. The baseline value is used as a reference to calculate the relative change from baseline. T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis. A T-score below -2.5 in combination with a prevalent fracture indicates serious osteoporosis.
2. Percent Change From Baseline in Total Hip T-score at Month 12 and 24 [ Time Frame: Baseline, Month 12, Month 24 ]
   Percent change was calculated as [(measure at time "t" - measure at baseline)/measure at baseline]*100, where t=12 and 24 months. The baseline value is used as a reference to calculate the relative change from baseline. T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis. A T-score below -2.5 in combination with a prevalent fracture indicates serious osteoporosis.
3. Percentage of Participants Who Received All Planned Study Medication (Compliance) [ Time Frame: Baseline up to Month 12 ]
4. Correlation Coefficient of Participant's Profile With Compliance [ Time Frame: Baseline up to Month 12 ]
   Participant's profile included age, year since menopause, fracture history, and BMD at baseline.

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Bosnia and Herzegovina

Banja Luka, Bosnia and Herzegovina, 78000

Sarajewo, Bosnia and Herzegovina, 71000

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

More Information

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT01290094
• Other Study ID Numbers: ML25399
• First Posted: February 4, 2011
• Results First Posted: August 13, 2015
• Last Update Posted: August 13, 2015
• Last Verified: June 2015

Additional relevant MeSH terms:

Osteoporosis; Osteoporosis, Postmenopausal; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Ibandronic Acid; Bone Density Conservation Agents; Physiological Effects of Drugs