NCT01290094

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2011

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 4, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 13, 2015

Completed
Last Updated

August 13, 2015

Status Verified

June 1, 2015

Enrollment Period

3.3 years

First QC Date

January 20, 2011

Results QC Date

July 17, 2015

Last Update Submit

July 17, 2015

Conditions

Post Menopausal Osteoporosis

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Secondary Outcomes (4)

  • Percent Change From Baseline in Lumbar Spine T-score at Month 12 and 24

    Baseline, Month 12, Month 24

  • Percent Change From Baseline in Total Hip T-score at Month 12 and 24

    Baseline, Month 12, Month 24

  • Percentage of Participants Who Received All Planned Study Medication (Compliance)

    Baseline up to Month 12

  • Correlation Coefficient of Participant's Profile With Compliance

    Baseline up to Month 12

Study Arms (1)

Single Arm

EXPERIMENTAL
Drug: ibandronate [Bonviva/Boniva]

Interventions

ibandronate [Bonviva/Boniva]DRUG

3 mg intravenously every 3 months

Single Arm

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Banja Luka, 78000, Bosnia and Herzegovina

Location

Unknown Facility

Sarajevo, 71000, Bosnia and Herzegovina

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Ibandronic Acid

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Results Point of Contact

Title
Medical Communications
Organization
Hoffmann-La Roche
genentech@druginfo.com
800-821-8590

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2011

First Posted

February 4, 2011

Study Start

April 1, 2011

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

August 13, 2015

Results First Posted

August 13, 2015

Record last verified: 2015-06

Locations

BO(2)