NCT00493623

Brief Summary

This 2 arm study will assess the efficacy and safety of intravenous Bonviva in patients with osteoporosis experiencing pain after recent vertebral osteoporotic fracture. Patients will be randomized to receive either Bonviva (3mg i.v. bolus injection) or placebo. The anticipated time on study treatment is \<3 months, 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
68

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2007

Geographic Reach
1 country

27 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

Study Start

First participant enrolled

June 1, 2007

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2007

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

March 2, 2016

Status Verified

March 1, 2016

Enrollment Period

2.5 years

First QC Date

June 27, 2007

Last Update Submit

March 1, 2016

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • Success of Bonviva therapy (>=20% diminution of pain intensity between day 0 and 7, with stabilization or diminution of concomitant analgesics between day 3 and 7).

    Day 7

Secondary Outcomes (5)

  • Percentage of patients with >=50% diminution of pain between day 0 and 7

    Day 7

  • Pain control

    Day 7 and 1 month

  • Analgesic medication

    1 month

  • Hospitalization

    1 month

  • AEs and laboratory parameters

    Throughout study

Study Arms (2)

1

EXPERIMENTAL
Drug: ibandronate [Bonviva/Boniva]

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PlaceboDRUG

Placebo i.v. single dose

2
ibandronate [Bonviva/Boniva]DRUG

3mg i.v. single dose

1

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • postmenopausal women or men \>30 years of age;
  • osteoporosis;
  • vertebral osteoporotic fracture in past 4 weeks;
  • fracture-related pain requiring analgesic treatment.

You may not qualify if:

  • non-menopausal women;
  • current treatment with another bisphosphonate;
  • current treatment with class III analgesics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Unknown Facility

Aix-en-Provence, 13616, France

Location

Unknown Facility

Amiens, 80054, France

Location

Unknown Facility

Angers, 49033, France

Location

Unknown Facility

Bonneville, 74136, France

Location

Unknown Facility

Bordeaux, 33076, France

Location

Unknown Facility

Caen, 14033, France

Location

Unknown Facility

Cannes, 06401, France

Location

Unknown Facility

Clermont-Ferrand, 63003, France

Location

Unknown Facility

Échirolles, 38434, France

Location

Unknown Facility

Lille, 59037, France

Location

Unknown Facility

Lomme, 59462, France

Location

Unknown Facility

Marseille, 13285, France

Location

Unknown Facility

Marseille, 13385, France

Location

Unknown Facility

Montpellier, 34295, France

Location

Unknown Facility

Mulhouse, 68070, France

Location

Unknown Facility

Nantes, 44035, France

Location

Unknown Facility

Nice, 06202, France

Location

Unknown Facility

Orléans, 45000, France

Location

Unknown Facility

Paris, 75181, France

Location

Unknown Facility

Paris, 75475, France

Location

Unknown Facility

Paris, 75571, France

Location

Unknown Facility

Paris, 75651, France

Location

Unknown Facility

Paris, 75674, France

Location

Unknown Facility

Rennes, 35203, France

Location

Unknown Facility

Rouen, 76031, France

Location

Unknown Facility

Saint-Priest-en-Jarez, 42277, France

Location

Unknown Facility

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Ibandronic Acid

Condition Hierarchy (Ancestors)

Bone 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
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

June 27, 2007

First Posted

June 28, 2007

Study Start

June 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

March 2, 2016

Record last verified: 2016-03

Locations

FR(27)