Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 35 of 232 for:    CALCITONIN SALMON

A Study for Patients With Osteoporosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00414973
Recruitment Status : Completed
First Posted : December 22, 2006
Results First Posted : August 26, 2009
Last Update Posted : October 28, 2009
Sponsor:
Information provided by:
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE December 20, 2006
First Posted Date  ICMJE December 22, 2006
Results First Submitted Date  ICMJE July 16, 2009
Results First Posted Date  ICMJE August 26, 2009
Last Update Posted Date October 28, 2009
Study Start Date  ICMJE December 2006
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2009)
Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Postmenopausal Women [ Time Frame: Baseline to 24 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 20, 2006)
Percentage change in lumbar spine bone mineral density at 24 weeks
Change History Complete list of historical versions of study NCT00414973 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2009)
  • Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Postmenopausal Women [ Time Frame: Baseline to 24 weeks ]
  • Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Postmenopausal Women [ Time Frame: Baseline to 12 weeks and 24 weeks ]
  • Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Men [ Time Frame: Baseline to 24 weeks ]
  • Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Men [ Time Frame: Baseline to 24 weeks ]
  • Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Men [ Time Frame: Baseline to 12 weeks and 24 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2006)
  • Percentage change in total hip bone mineral density at 24 weeks
  • percentage change in biochemical bone marker (osteocalcin) at 12 and 24 weeks
  • Safety (physical examination, vital signs, clinical laboratory data and adverse events) at 24 weeks
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study for Patients With Osteoporosis
Official Title  ICMJE Comparison of Teriparatide and Calcitonin in the Treatment of Men and Postmenopausal Women With Osteoporosis
Brief Summary The purpose of this study is to compare the effect of injectable teriparatide to intranasal salmon calcitonin on lumbar spine bone mineral density, in the treatment of Chinese patients with established osteoporosis
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Osteoporosis
Intervention  ICMJE
  • Drug: Teriparatide
    Subcutaneous, 20 micrograms/day, 24 weeks
    Other Names:
    • LY333334
    • Forteo
    • Forsteo
  • Drug: Salmon Calcitonin
    Intranasal, 200 International Units (IU)/day, 24 weeks
Study Arms  ICMJE
  • Experimental: A
    Intervention: Drug: Teriparatide
  • Active Comparator: B
    Intervention: Drug: Salmon Calcitonin
Publications * Not Provided

*   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: July 23, 2008)
364
Original Enrollment  ICMJE
 (submitted: December 20, 2006)
450
Actual Study Completion Date  ICMJE July 2008
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinical diagnosis of osteoporosis
  • No other severe disabling conditions
  • Should have at least 1 vertebral or non-vertebral prevalent fracture, and bone mineral density T-score should be less than -2.5
  • Ambulatory
  • Men (aged 40 to 85 years) or postmenopausal women (aged 55 to 85 years)

Exclusion Criteria:

  • History of a disease that affects bone metabolism
  • History of treatment with any drug that may significantly affect bone metabolism
  • History or presence of liver disease
  • History or presence of kidney disease
  • History of excessive alcohol drinking or drug abuse
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00414973
Other Study ID Numbers  ICMJE 10591
B3D-MC-GHDG
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chief Medical Officer, Eli Lilly
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date October 2009

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