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Using Soy Estrogens to Prevent Bone Loss and Other Menopausal Symptoms (SPARE)

This study has been completed.
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Silvina Levis, MD, University of Miami
ClinicalTrials.gov Identifier:
NCT00076050
First received: January 13, 2004
Last updated: October 12, 2016
Last verified: October 2016
Results First Received: June 26, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Menopause
Osteoporosis
Osteopenia
Interventions: Dietary Supplement: Soy isoflavones
Dietary Supplement: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Soy Isoflavone Group A total of 122 participants were randomized to receive a 200-mg dose of soy isoflavones in tablet form daily by mouth, over 2 years. The medication was delivered in four tablets that had to be taken fasting in the morning.
Placebo Group A total of 126 participants were randomized to receive placebo tablets by mouth daily over 2 years.The medication was delivered in four tablets that had to be taken fasting in the morning.

Participant Flow:   Overall Study
    Soy Isoflavone Group   Placebo Group
STARTED   122   126 
COMPLETED   99   83 
NOT COMPLETED   23   43 



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Soy Isoflavone Group A total of 122 participants were randomized to receive a 200-mg dose of soy isoflavones in tablet form daily by mouth, over 2 years. The medication was delivered in four tablets that had to be taken fasting in the morning.
Placebo Group A total of 126 participants were randomized to receive placebo tablets by mouth daily over 2 years.The medication was delivered in four tablets that had to be taken fasting in the morning.
Total Total of all reporting groups

Baseline Measures
   Soy Isoflavone Group   Placebo Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 122   126   248 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   122   126   248 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 53  (3.3)   52  (3.3)   52.5  (3.3) 
Gender 
[Units: Participants]
     
Female   122   126   248 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   122   126   248 


  Outcome Measures
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1.  Primary:   Change From Baseline in Bone Mineral Density   [ Time Frame: baseline and 2 years ]

2.  Secondary:   Changes in Women's Health Questionnaire Score   [ Time Frame: baseline and 2 years ]

3.  Secondary:   Change in Vaginal Maturation Value   [ Time Frame: baseline and 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Silvina Levis MD
Organization: University of Miami
phone: 305-575-3388
e-mail: slevis@med.miami.edu


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

Responsible Party: Silvina Levis, MD, University of Miami
ClinicalTrials.gov Identifier: NCT00076050     History of Changes
Other Study ID Numbers: R01AR048932 ( US NIH Grant/Contract Award Number )
NIAMS-114
SPARE
Study First Received: January 13, 2004
Results First Received: June 26, 2013
Last Updated: October 12, 2016
Health Authority: United States: Federal Government