NCT00100620

Brief Summary

The intake of high doses of corticosteroids is known to play an important role in the weakening of the bones and is thus an increasing fracture risk. Zoledronic acid (Aclasta) is a drug known for its protective effect in some bone diseases (tumors, paget). This study will test the safety and efficacy of zoledronic acid in the prevention and treatment of corticosteroid induced osteoporosis in male and female patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
802

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2004

Typical duration for phase_3

Geographic Reach
1 country

6 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, 2004

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

May 17, 2017

Status Verified

May 1, 2017

Enrollment Period

2.8 years

First QC Date

January 3, 2005

Last Update Submit

May 15, 2017

Conditions

Osteoporosis

Keywords

Corticosteroid induced osteoporosispreventiontreatmentzoledronic acid

Outcome Measures

Primary Outcomes (1)

  • Percent change in lumbar spine Bone Mineral Density at Month 12 relative to baseline.

Secondary Outcomes (4)

  • Percent change in lumbar spine Bone Mineral Density at Month 6 relative to baseline

  • Percent change in total hip, femoral neck, trochanter and distal radius Bone Mineral Density at Months 6 and 12 relative to baseline

  • Biochemical markers of bone turnover at Baseline, Day 10, Month 3, Month 6, Month 12

  • Overal safety of zoledronic acid compared to risedronate in patients receiving corticosteroid therapy

Interventions

Zoledronic AcidDRUG

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Long duration treatment with corticosteroids (started or ongoing)

You may not qualify if:

  • History of osteogenesis imperfecta, multiple myeloma or Paget's disease
  • History of Hyperparathyroidism, hyperthyroidism
  • History of Osteomalacia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Center for Education and research on Therapeutics (CERTs) of Musculoskeletal Disorders

Birmingham, Alabama, 35294-3708, United States

Location

United Osteoporosis Centers

Gainesville, Georgia, 30501, United States

Location

Osteoporosis & Clinical Trials

Cumberland, Maryland, 21502, United States

Location

University of Ohio

Columbus, Ohio, 43210, United States

Location

Radiant Research

Wyomissing, Pennsylvania, 19610, United States

Location

McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location

Related Publications (3)

  • Devogelaer JP, Sambrook P, Reid DM, Goemaere S, Ish-Shalom S, Collette J, Su G, Bucci-Rechtweg C, Papanastasiou P, Reginster JY. Effect on bone turnover markers of once-yearly intravenous infusion of zoledronic acid versus daily oral risedronate in patients treated with glucocorticoids. Rheumatology (Oxford). 2013 Jun;52(6):1058-69. doi: 10.1093/rheumatology/kes410. Epub 2013 Jan 30.

    PMID: 23365149DERIVED

  • Grbic JT, Black DM, Lyles KW, Reid DM, Orwoll E, McClung M, Bucci-Rechtweg C, Su G. The incidence of osteonecrosis of the jaw in patients receiving 5 milligrams of zoledronic acid: data from the health outcomes and reduced incidence with zoledronic acid once yearly clinical trials program. J Am Dent Assoc. 2010 Nov;141(11):1365-70. doi: 10.14219/jada.archive.2010.0082.

    PMID: 21037195DERIVED

  • Reid DM, Devogelaer JP, Saag K, Roux C, Lau CS, Reginster JY, Papanastasiou P, Ferreira A, Hartl F, Fashola T, Mesenbrink P, Sambrook PN; HORIZON investigators. Zoledronic acid and risedronate in the prevention and treatment of glucocorticoid-induced osteoporosis (HORIZON): a multicentre, double-blind, double-dummy, randomised controlled trial. Lancet. 2009 Apr 11;373(9671):1253-63. doi: 10.1016/S0140-6736(09)60250-6.

    PMID: 19362675DERIVED

MeSH Terms

Conditions

Osteoporosis

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone 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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2005

First Posted

January 4, 2005

Study Start

June 1, 2004

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

May 17, 2017

Record last verified: 2017-05

Locations

US(6)