NCT00545207

Brief Summary

This 2 arm study will compare the effect of oral Bonviva (150mg, monthly) and placebo on parameters of bone micro-architecture, assessed by CT scan, bone turnover and bone mineral density. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, and measurements will be taken at baseline, and at intervals over 2 years. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

4 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

October 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2007

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

January 26, 2017

Status Verified

January 1, 2017

First QC Date

October 16, 2007

Last Update Submit

January 25, 2017

Conditions

Post-Menopausal Osteopenia

Outcome Measures

Primary Outcomes (1)

  • Trabecular BV/TV at distal radius of non-dominant arm

    12 arms

Secondary Outcomes (5)

  • Trabecular BV/TV at distal radius of non-dominant arm

    6 months and 2 years

  • Bone density, trabecular BV/TV at distal tibia

    6 months, 1 and 2 years

  • Serum CTX

    Intervals throughout study

  • Lumbar hip and wrist BMD

    1 and 2 years

  • AEs and laboratory parameters

    Throughout study

Study Arms (2)

1

EXPERIMENTAL
Drug: ibandronate [Bonviva/Boniva]

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

ibandronate [Bonviva/Boniva]DRUG

150mg po monthly for 2 years

1
PlaceboDRUG

po monthly for 2 years

2

Eligibility Criteria

Age55 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • post-menopausal women, aged 55-75 years;
  • diagnosed osteopenia.

You may not qualify if:

  • history of osteoporotic vertebral fracture;
  • contraindication to ibandronate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Lyon, 69437, France

Location

Unknown Facility

Paris, 75475, France

Location

Unknown Facility

Saint-Priest-en-Jarez, 42277, France

Location

Unknown Facility

Toulouse, 31059, France

Location

MeSH Terms

Interventions

Ibandronic Acid

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2007

First Posted

October 17, 2007

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

January 26, 2017

Record last verified: 2017-01

Locations

FR(4)