NCT00129623

Brief Summary

This 2 arm study will evaluate the efficacy and safety of oral Bonviva 150mg once monthly compared with placebo in post-menopausal women with osteopenia. Patients will be randomized to receive either Bonviva 150mg po monthly, or placebo monthly. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2005

Geographic Reach
1 country

12 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

August 11, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 12, 2005

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
8.1 years until next milestone

Results Posted

Study results publicly available

January 11, 2016

Completed
Last Updated

January 11, 2016

Status Verified

December 1, 2015

Enrollment Period

2 years

First QC Date

August 11, 2005

Results QC Date

December 5, 2015

Last Update Submit

December 5, 2015

Conditions

Post-Menopausal Osteopenia

Outcome Measures

Primary Outcomes (1)

  • Relative Change From Baseline in Mean Bone Mineral Density (BMD) of the Lumbar Spine (L2 to L4) at Month 12

    BMD was measured by a single dual-energy x-ray absorptiometry (DEXA) scan of the lumbar spine at the time of screening and at Month 12. A BMD measurement was considered unsuitable in case of detection of a fracture, an osteoarthritic process, or a scanning artifact that could not be removed to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center. The change in BMD was defined as the relative difference between the last individual measurement available at 12 months and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year - BMD at baseline) / (BMD at baseline)

    Baseline and Month 12

Secondary Outcomes (8)

  • Absolute Change From Baseline in Mean Lumbar Spine BMD at Month 12

    Baseline and Month 12

  • Relative Change From Baseline in Mean Proximal Femur BMD at Month 12

    Baseline and Month 12

  • Absolute Change From Baseline in BMD of the Proximal Femur at Month 12

    Baseline and Month 12

  • Relative Change From Baseline in Serum C-telopeptide Crosslinks of Type 1 Collagen (CTX)

    Baseline and 3, 6 and 12 months

  • Absolute Change From Baseline in sCTX

    Baseline and 3, 6, 12 months

  • +3 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL
Drug: ibandronate [Bonviva/Boniva]

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PlaceboDRUG

po monthly for 1 year

2
ibandronate [Bonviva/Boniva]DRUG

150mg po monthly for 1 year

1

Eligibility Criteria

Age45 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women 45-60 years of age;
  • post-menopausal;
  • ambulatory.

You may not qualify if:

  • vertebral fracture (except traumatic fracture such as in a motor vehicle accident);
  • low-trauma osteoporotic fracture in any other bone;
  • breast cancer diagnosed within last 20 years;
  • other malignancy diagnosed within last 10 years, except successfully resected basal cell cancer;
  • treatment with any bisphosphonate within last 2 years;
  • treatment with other drugs affecting bone metabolism within last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Unknown Facility

Lakewood, Colorado, 80227, United States

Location

Unknown Facility

Stuart, Florida, 34996, United States

Location

Unknown Facility

Bethesda, Maryland, 20817, United States

Location

Unknown Facility

Detroit, Michigan, 48236, United States

Location

Unknown Facility

St Louis, Missouri, 63110, United States

Location

Unknown Facility

Omaha, Nebraska, 68131, United States

Location

Unknown Facility

Albuquerque, New Mexico, 87106, United States

Location

Unknown Facility

Cincinnati, Ohio, 45224, United States

Location

Unknown Facility

Portland, Oregon, 97213, United States

Location

Unknown Facility

Amarillo, Texas, 79124, United States

Location

Unknown Facility

Norfolk, Virginia, 23502, United States

Location

Unknown Facility

Richmond, Virginia, 23294, United States

Location

MeSH Terms

Interventions

Ibandronic Acid

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Results Point of Contact

Title
Roche Trial Information Hotline
Organization
F. Hoffmann-La Roche AG
global.trial_information@roche.com
+41 61 6878333

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 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2005

First Posted

August 12, 2005

Study Start

December 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

January 11, 2016

Results First Posted

January 11, 2016

Record last verified: 2015-12

Locations

US(12)