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Double-blind Extension of HORIZON Pivotal Fracture Trial (Zoledronic Acid in the Treatment of Postmenopausal Osteoporosis)

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ClinicalTrials.gov Identifier: NCT00145327
Recruitment Status : Completed
First Posted : September 5, 2005
Results First Posted : April 20, 2011
Last Update Posted : June 28, 2011
Sponsor:
Information provided by:
Novartis

Tracking Information
First Submitted Date  ICMJE September 1, 2005
First Posted Date  ICMJE September 5, 2005
Results First Submitted Date  ICMJE January 21, 2011
Results First Posted Date  ICMJE April 20, 2011
Last Update Posted Date June 28, 2011
Study Start Date  ICMJE May 2005
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2011)
Percentage Change in Bone Mineral Density (BMD) of Femoral Neck at Year 6 Relative to Year 3 [ Time Frame: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72; end of extension study) ]
The primary efficacy variable was the percentage change in BMD of the femoral neck as measured by dual x-ray absorptiometry (DXA) at Year 6 relative to Year 3. It was derived as 100 *(femoral neck BMD at Year 6 - femoral neck BMD at Year 3) / (femoral neck BMD at Year 3).
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2011)
  • Bone Resorption and Formation Biochemical Markers at Year 4.5: P1NP [ Time Frame: Year 4.5 ]
    The amount of serum n-terminal propeptide of type I collagen (P1NP) as determined by the central laboratory.
  • Bone Resorption and Formation Biochemical Markers at Year 6: P1NP [ Time Frame: Year 6 ]
    The amount of serum P1NP as determined by the central laboratory
  • Percentage Change in BMD of Lumbar Spine at Year 4.5 Relative to Year 3 [ Time Frame: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 4.5 (Month 54) ]
    The percentage change in BMD as measured by DXA at Year 4.5 relative to Year 3. It was derived as 100 * (BMD at Year 4.5 - BMD at Year 3)/(BMD at Year 3).
  • Percentage Change in BMD of Lumbar Spine at Year 6 Relative to Year 3 [ Time Frame: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 ]
    The percentage change in BMD as measured by DXA at Year 6 relative to Year 3. It was derived as 100 * (BMD at Year 6 - BMD at Year 3)/(BMD at Year 3).
  • Percentage Change in BMD of Distal Radius at Year 4.5 Relative to Year 3 [ Time Frame: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 4.5 (Month 54) ]
    The percentage change in BMD as measured by DXA at Year 4.5 relative to Year 3. It was derived as 100 * (BMD at Year 4.5 - BMD at Year 3)/(BMD at Year 3).
  • Percentage Change in BMD of Distal Radius at Year 6 Relative to Year 3 [ Time Frame: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72) ]
    The percentage change in BMD as measured by DXA at Year 6 relative to Year 3. It was derived as 100 * (BMD at Year 6 - BMD at Year 3)/(BMD at Year 3).
  • Percentage Change in BMD of Femoral Neck, Total Hip and Trochanter at Year 4.5 Relative to Year 3 [ Time Frame: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 4.5 (Month 54) ]
    The percentage change in BMD as measured by DXA at 4.5 relative to Year 3. It was derived as 100 * (BMD at Year 4.5 - BMD at Year 3)/(BMD at Year 3).
  • Percentage Change in BMD of Femoral Neck, Total Hip and Trochanter at Year 6 Relative to Year 3 [ Time Frame: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72) ]
    The percentage change in BMD as measured by DXA at Year 6 relative to Year 3. It was derived as 100 * (BMD at Year 6 - BMD at Year 3)/(BMD at Year 3).
  • Percentage of Patients With New and New/Worsening Morphometric Vertebral Fractures [ Time Frame: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 ]
    Lateral vertebral x-rays were performed at the final core study visit and at Year 6 and read by a central expert reader at a central imaging laboratory to assess for new or new/worsening morphometric vertebral fracture. The percentage of patients with new morphometric vertebral fractures (observed for the first time) and patients with either new or worsening morphometric vertebral fractures was calculated.
  • Number of Participants With Incidence of Clinical Fracture [ Time Frame: Extension Baseline (Year 3; Month 36) to Year 6 ]
    Clinical fracture excludes finger, toe, and facial bone fractures. Clinical vertebral fracture includes thoracic spine fracture and lumbar spine fracture. Non-vertebral fracture excludes clinical vertebral, finger, toe, and facial bone fractures.
  • Qualitative Bone Biopsy Parameters [ Time Frame: End of Study Visit at Year 6 ]
    Unpaired transiliac crest bone biopsy was performed for histomorphometry, which was obtained after double tetracycline labeling. No data were collected for Patients who received Placebo for the first 3 years of the study (Placebo 3 Zoledronic Acid 3).
  • Change in Serum Creatinine From Baseline to 9-11 Days Post Year 3 Infusion [ Time Frame: Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to 9-11 days after the Year 3 infusion ]
    Serum creatinine measurements performed by a central laboratory was used to evaluate acute changes in renal function 9-11 days after study drug infusion in Z6 patients compared to Z3P3 patients and in P3Z3 patients.
  • Change in Serum Creatinine From Baseline to 9-11 Days Post Year 4 Infusion [ Time Frame: Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to 9-11 days after the Year 4 infusion ]
    Serum creatinine measurements performed by a central laboratory was used to evaluate acute changes in renal function 9-11 days after Year 4 study drug infusion.
  • Change in Serum Creatinine From Baseline to 9-11 Days Post Year 5 Infusion [ Time Frame: Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to 9-11 days after the Year 5 infusion ]
    Serum creatinine measurements performed by a central laboratory was used to evaluate acute changes in renal function 9-11 days after Year 5 study drug infusion.
  • The Number of Participants With Clinically Significant Laboratory Parameters [ Time Frame: Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to Year 6 ]
    Evaluate the laboratory key profile such as Calcium, Creatinine and Urea. The number of patients with clinically significant calcium, creatinine and urea were reported.
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 Double-blind Extension of HORIZON Pivotal Fracture Trial (Zoledronic Acid in the Treatment of Postmenopausal Osteoporosis)
Official Title  ICMJE A 3-year, Double-blind Extension to CZOL446H2301 to Evaluate the Long-term Safety and Efficacy of Zoledronic Acid in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D
Brief Summary This extension study is designed to assess the long term safety and efficacy of zoledronic acid in postmenopausal women with osteoporosis who have participated in the CZOL446H2301 (NCT00049829): HORIZON Pivotal Fracture Trial. This extension study began after the 3-year core study ended. Baseline is the same as Year 3.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoporosis
Intervention  ICMJE
  • Drug: Zoledronic Acid
    Zoledronic Acid 5 mg in 100 mL physiologic 0.9% normal saline for intravenous infusion.
    Other Name: Reclast, Aclasta
  • Drug: Placebo
    100 mL physiologic 0.9% normal saline for intravenous infusion.
    Other Name: Reclast, Aclasta
Study Arms  ICMJE
  • Experimental: Zoledronic Acid 6
    Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
    Intervention: Drug: Zoledronic Acid
  • Placebo Comparator: Zoledronic Acid 3 Placebo 3
    Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
    Intervention: Drug: Placebo
  • Experimental: Placebo 3 Zoledronic Acid 3
    Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
    Intervention: Drug: Zoledronic Acid
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
Actual Enrollment  ICMJE
 (submitted: March 23, 2011)
2456
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE November 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients who have received 3 infusions in the HORIZON-Pivotal Fracture (PFT) Study.

Exclusion Criteria:

  • Poor kidney, eye, or liver health
  • Use of certain therapies for osteoporosis in the HORIZON-PFT study (other than the study medication)
  • Abnormal calcium levels in the blood

Other protocol-defined inclusion/exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 68 Years to 90 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00145327
Other Study ID Numbers  ICMJE CZOL446H2301E1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party External Affairs, Novartis
Study Sponsor  ICMJE Novartis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Novartis Pharmaceuticals Sponsor GmbH
PRS Account Novartis
Verification Date June 2011

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