NCT01128257

Brief Summary

This observational study will assess the compliance and persistence of patients, real life efficacy and safety of intravenously quarterly administered 3 mg ibandronate \[Bonviva/Boniva\] in comparison to oral alendronate generics in female patients with post-menopausal osteoporosis. The anticipated time of assessment is 12 months. The target sample size is 5000-7000 patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6,054

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

April 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 3, 2010

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 21, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

1.7 years

First QC Date

May 3, 2010

Last Update Submit

November 1, 2016

Conditions

Postmenopausal Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • Assessment of compliance and persistence of Bonviva therapy: Number of prescriptions, number of applied injections, number of taken oral medication, continuation and duration of treatment

    12 months

Secondary Outcomes (8)

  • Pain intensity and reduction in use of analgesics

    12 months

  • Quality of life and patients satisfaction

    12 months

  • Degree of patient's mobility

    12 months

  • Incidence of new osteoporotic fractures

    12 months

  • Controllability and management of therapy by the physician

    12 months

  • +3 more secondary outcomes

Study Arms (2)

1

Drug: ibandronate [Bonviva/Boniva]

2

Drug: alendronate

Interventions

alendronateDRUG

As prescribed by physician

2
ibandronate [Bonviva/Boniva]DRUG

As prescribed by physician

1

Eligibility Criteria

Age55 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Female post-menopausal patients over the age of 55 years

You may qualify if:

  • Adult patients, \>/= 55 years of age
  • Postmenopausal osteoporosis
  • Patients who are in the opinion of the physician eligible to participate in this study

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Marburg, 35043, Germany

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

AlendronateIbandronic Acid

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2010

First Posted

May 21, 2010

Study Start

April 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

DE(1)