NCT00145275

Brief Summary

Zoledronic acid is a medicine being studied in people with low bone mass. Side effects such as headache, fever, muscle aches, and pains, may occur following the infusion. This study will investigate the use of over-the-counter medicines to improve these symptoms.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
455

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2004

Shorter than P25 for phase_3

Geographic Reach
5 countries

10 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

December 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

April 27, 2012

Status Verified

April 1, 2012

Enrollment Period

10 months

First QC Date

September 1, 2005

Last Update Submit

April 26, 2012

Conditions

Osteopenia

Keywords

zoledronic acidbisphosphonateLow bone mass

Outcome Measures

Primary Outcomes (1)

  • Temperature increase

Secondary Outcomes (2)

  • Questionnaires

  • VAS (visual analog scale)

Interventions

zoledronic acidDRUG

Eligibility Criteria

Age45 Years - 75 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women greater than or equal to 45 years and less than or equal to 75 years of age inclusive
  • Low bone mineral density

You may not qualify if:

  • Certain prior treatments for low bone mass/osteopenia
  • Current use of medicines (prescription or non-prescription) for pain, fever, or inflammation
  • Impaired kidney function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Unknown Facility

Unavailable, Georgia, United States

Location

Unknown Facility

Unavailable, Illinois, United States

Location

Unknown Facility

Unavailable, Indiana, United States

Location

Unknown Facility

Unavailable, Iowa, United States

Location

Unknown Facility

Unavailable, Kansas, United States

Location

Unknown Facility

Unavailable, Washington, United States

Location

Unknown Facility

Multiple, Australia

Location

Unknown Facility

Multiple, Canada

Location

Unknown Facility

Multiple, Russia

Location

Unknown Facility

Multiple, South Africa

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 5, 2005

Study Start

December 1, 2004

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

April 27, 2012

Record last verified: 2012-04

Locations

US(6)RU(1)AU(1)CA(1)ZA(1)