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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01290094
Other study ID # ML25399
Secondary ID
Status Completed
Phase Phase 3
First received January 20, 2011
Last updated July 17, 2015
Start date April 2011
Est. completion date July 2014

Study information

Verified date June 2015
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority Bosnia and Herzegovina: Agency for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender Female
Age group 50 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
ibandronate [Bonviva/Boniva]
3 mg intravenously every 3 months

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Bosnia and Herzegovina, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at 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. Baseline, Month 12 No
Primary Percent Change From Baseline in Mean Lumbar Spine BMD at 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. Baseline, Month 24 No
Primary Percent Change From Baseline in Mean Hip Bone BMD at 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. Baseline, Month 12 No
Primary Percent Change From Baseline in Mean Hip BMD at 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. Baseline, Month 24 No
Secondary Percent Change From Baseline in Lumbar Spine T-score at Month 12 and 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. Baseline, Month 12, Month 24 No
Secondary Percent Change From Baseline in Total Hip T-score at Month 12 and 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. Baseline, Month 12, Month 24 No
Secondary Percentage of Participants Who Received All Planned Study Medication (Compliance) Baseline up to Month 12 No
Secondary Correlation Coefficient of Participant's Profile With Compliance Participant's profile included age, year since menopause, fracture history, and BMD at baseline. Baseline up to Month 12 No
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