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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00100620

Collaborator

(none)

802

Enrollment

Locations

Duration (Months)

133.7

Patients Per Site

3.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis	Drug: Zoledronic Acid	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2004

Actual Primary Completion Date :

Apr 1, 2007

Actual Study Completion Date :

Apr 1, 2007

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Education and research on Therapeutics (CERTs) of Musculoskeletal Disorders	Birmingham	Alabama	United States	35294-3708
2	United Osteoporosis Centers	Gainesville	Georgia	United States	30501
3	Osteoporosis & Clinical Trials	Cumberland	Maryland	United States	21502
4	University of Ohio	Columbus	Ohio	United States	43210
5	Radiant Research	Wyomissing	Pennsylvania	United States	19610
6	McGuire VA Medical Center	Richmond	Virginia	United States	23249