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Trial record 39 of 1227 for:    "Osteoporosis"

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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Osteoporosis
Interventions: Drug: SMC021 Oral calcitonin
Drug: SMC021 Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Patients were enrolled at 16 centers in 12 countries:

3 centers in the US and 3 centers in Denmark.

1 center in Brazil, Estonia, Czech Republic, Poland, Lithuania, Romania, Italy, France, Hong Kong, and China.

First patient randomized: 26 Feb 2007 Last patient visit: 30 Jul 2011


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
SMC021 1 tablet of 0,80 mg SMC021 daily
Placebo 1 tablet of placebo daily

Participant Flow:   Overall Study
    SMC021   Placebo
STARTED   2334   2331 
COMPLETED   1578   1732 
NOT COMPLETED   756   599 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
SMC021 1 tablet of 0,80 mg SMC021 daily
Placebo 1 tablet of placebo daily
Total Total of all reporting groups

Baseline Measures
   SMC021   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 2334   2331   4665 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   912   860   1772 
>=65 years   1422   1471   2893 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.5  (6.12)   67.0  (6.16)   66.8  (6.14) 
Gender 
[Units: Participants]
     
Female   2334   2331   4665 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   31   30   61 
France   2   2   4 
Hong Kong   74   73   147 
Czech Republic   230   232   462 
Estonia   167   166   333 
Brazil   492   492   984 
Poland   176   176   352 
Lithuania   149   150   299 
Romania   172   171   343 
Denmark   599   598   1197 
Italy   18   17   35 
China   224   224   448 


  Outcome Measures

1.  Primary:   Number of Patients With New Vertebral Fractures   [ Time Frame: From baseline to month 36 ]

2.  Secondary:   Number of Patients With Non-vertebral Fractures   [ Time Frame: From baseline to month 36 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Bente Juul Riis
Organization: Nordic Bioscience
phone: +45 22901317
e-mail: bjr@nordicbioscience.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Nordic Bioscience A/S
ClinicalTrials.gov Identifier: NCT00525798     History of Changes
Other Study ID Numbers: SMC021A2303
First Submitted: September 5, 2007
First Posted: September 6, 2007
Results First Submitted: September 14, 2012
Results First Posted: October 18, 2012
Last Update Posted: October 29, 2012