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Efficacy and Safety of Zoledronic Acid in the Prevention and Treatment of Corticosteroid Induced Osteoporosis

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Zoledronic Acid
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring Corticosteroid induced osteoporosis, prevention, treatment, zoledronic acid

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All Sexes

Inclusion Criteria: Long duration treatment with corticosteroids (started or ongoing) Exclusion Criteria: History of osteogenesis imperfecta, multiple myeloma or Paget's disease History of Hyperparathyroidism, hyperthyroidism History of Osteomalacia Other protocol-defined inclusion/exclusion criteria may apply.

Sites / Locations

  • Center for Education and research on Therapeutics (CERTs) of Musculoskeletal Disorders
  • United Osteoporosis Centers
  • Osteoporosis & Clinical Trials
  • University of Ohio
  • Radiant Research
  • McGuire VA Medical Center

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 3, 2005
Last Updated
May 15, 2017
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00100620
Brief Title
Efficacy and Safety of Zoledronic Acid in the Prevention and Treatment of Corticosteroid Induced Osteoporosis
Official Title
Efficacy and Safety of Zoledronic Acid in the Prevention and Treatment of Corticosteroid Induced Osteoporosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Corticosteroid induced osteoporosis, prevention, treatment, zoledronic acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
802 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Zoledronic Acid
Primary Outcome Measure Information:
Title
Percent change in lumbar spine Bone Mineral Density at Month 12 relative to baseline.
Secondary Outcome Measure Information:
Title
Percent change in lumbar spine Bone Mineral Density at Month 6 relative to baseline
Title
Percent change in total hip, femoral neck, trochanter and distal radius Bone Mineral Density at Months 6 and 12 relative to baseline
Title
Biochemical markers of bone turnover at Baseline, Day 10, Month 3, Month 6, Month 12
Title
Overal safety of zoledronic acid compared to risedronate in patients receiving corticosteroid therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Eligibility Criteria
Inclusion Criteria: Long duration treatment with corticosteroids (started or ongoing) Exclusion Criteria: History of osteogenesis imperfecta, multiple myeloma or Paget's disease History of Hyperparathyroidism, hyperthyroidism History of Osteomalacia Other protocol-defined inclusion/exclusion criteria may apply.
Facility Information:
Facility Name
Center for Education and research on Therapeutics (CERTs) of Musculoskeletal Disorders
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3708
Country
United States
Facility Name
United Osteoporosis Centers
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Osteoporosis & Clinical Trials
City
Cumberland
State/Province
Maryland
ZIP/Postal Code
21502
Country
United States
Facility Name
University of Ohio
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Radiant Research
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
McGuire VA Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23365149
Citation
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.
Results Reference
derived
PubMed Identifier
21037195
Citation
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.
Results Reference
derived
PubMed Identifier
19362675
Citation
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.
Results Reference
derived

Learn more about this trial

Efficacy and Safety of Zoledronic Acid in the Prevention and Treatment of Corticosteroid Induced Osteoporosis

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