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Trial record 11 of 232 for:    CALCITONIN SALMON

A Study to Evaluate Oral Salmon Calcitonin in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D

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ClinicalTrials.gov Identifier: NCT00525798
Recruitment Status : Completed
First Posted : September 6, 2007
Results First Posted : October 18, 2012
Last Update Posted : October 29, 2012
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Nordic Bioscience A/S

Tracking Information
First Submitted Date  ICMJE September 5, 2007
First Posted Date  ICMJE September 6, 2007
Results First Submitted Date  ICMJE September 14, 2012
Results First Posted Date  ICMJE October 18, 2012
Last Update Posted Date October 29, 2012
Study Start Date  ICMJE March 2007
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2012)
Number of Patients With New Vertebral Fractures [ Time Frame: From baseline to month 36 ]
The primary variable was the occurrence or not of a new vertebral fracture during the 3 year observation period. New vertebral fractures were identified from an assessment of x-ray of the lateral spine through time (at baseline and at yearly intervals thereafter). The outcome is the number of new vertebral fractures from baseline to 36 months.
Original Primary Outcome Measures  ICMJE
 (submitted: September 5, 2007)
Number of Patients With New Vertebral Fractures
Change History Complete list of historical versions of study NCT00525798 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2012)
Number of Patients With Non-vertebral Fractures [ Time Frame: From baseline to month 36 ]
The secondary outcome was the occurrence or not of a non-vertebral fracture during the 3 year observation period. Non-vertebral fractures of interest were: hip fractures, forearm fractures, humurus fractures, rib fractures and clavicular fractures. Any new non-vertebral fractures while on-study were recorded. A copy of radiographs confirming the fracture, as well as a copy of the radiologist's report was to be obtained. A copy of the emergency room discharge letter or a hospital discharge letter was also obtained.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2007)
Number of patients with non-vertebral farctures
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate Oral Salmon Calcitonin in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D
Official Title  ICMJE A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Salmon Calcitonin in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D
Brief Summary The purpose of this Phase III study is to evaluate the efficacy and safety of oral salmon calcitonin in the treatment of patients with osteoporosis
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: SMC021 Oral calcitonin
    0.8mg SMC021 - oral calcitonin, once daily
  • Drug: SMC021 Placebo
    SMC021 - Placebo, once daily
Study Arms  ICMJE
  • Active Comparator: 1
    SMC021 - Oral Calcitonin
    Intervention: Drug: SMC021 Oral calcitonin
  • Placebo Comparator: SMC021- Placebo
    SMC021 - placebo
    Intervention: Drug: SMC021 Placebo
Publications * Henriksen K, Bay-Jensen AC, Christiansen C, Karsdal MA. Oral salmon calcitonin--pharmacology in osteoporosis. Expert Opin Biol Ther. 2010 Nov;10(11):1617-29. doi: 10.1517/14712598.2010.526104. Epub 2010 Oct 11. Review.

*   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 22, 2012)
4665
Original Estimated Enrollment  ICMJE
 (submitted: September 5, 2007)
4500
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Postmenopausal women with osteoporosis, ambulatory, in general good health, not receiving medication that affects bone metabolism, and free from any underlying condition, other than osteoporosis, that may result in abnormal bone metabolism.

Exclusion Criteria:

  • BMD T-score below -4.0 (based on absolute values g/cm2 as given in the protocol) at one or more of the measured sites
  • More than 2 prevalent vertebral fractures (Genant et al, 15).
  • If BMD is lower than -2.5 T-score at one or more of the measured sites, the participants will be excluded from the study, if they have a severe vertebral fracture (Genant et al, 15).
  • Evidence of any clinical osteoporotic fracture and/or if they have a history of a clinical osteoporotic fracture (excluding wrist fractures)
  • BMD T-score > -1.5 in all of the following regions: Lumbar spine, femoral neck or total hip.

Other protocol defined inclusion/exclusion criteria may apply

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 55 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 Brazil,   China,   Czech Republic,   Denmark,   Estonia,   France,   Hong Kong,   Italy,   Lithuania,   Poland,   Romania,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00525798
Other Study ID Numbers  ICMJE SMC021A2303
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nordic Bioscience A/S
Study Sponsor  ICMJE Nordic Bioscience A/S
Collaborators  ICMJE Novartis
Investigators  ICMJE
Study Chair: Bente J Riis, M.D. Nordic Bioscience A/S
PRS Account Nordic Bioscience A/S
Verification Date October 2012

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