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Trial record 1 of 2 for:    19362675 [PUBMED-IDS]
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Efficacy and Safety of Zoledronic Acid in the Prevention and Treatment of Corticosteroid Induced Osteoporosis

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ClinicalTrials.gov Identifier: NCT00100620
Recruitment Status : Completed
First Posted : January 4, 2005
Last Update Posted : May 17, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE January 3, 2005
First Posted Date  ICMJE January 4, 2005
Last Update Posted Date May 17, 2017
Study Start Date  ICMJE June 2004
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2006)
Percent change in lumbar spine Bone Mineral Density at Month 12 relative to baseline.
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
Change in Lumbar Spine Bone Mineral Density (BMD)
Change History Complete list of historical versions of study NCT00100620 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2006)
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Zoledronic Acid in the Prevention and Treatment of Corticosteroid Induced Osteoporosis
Official Title  ICMJE Efficacy and Safety of Zoledronic Acid in the Prevention and Treatment of Corticosteroid Induced Osteoporosis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Osteoporosis
Intervention  ICMJE Drug: Zoledronic Acid
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: July 24, 2006)
802
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE April 2007
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00100620
Other Study ID Numbers  ICMJE CZOL446O2306
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Novartis
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP