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Trial record 5 of 74 for:    estrogen replacement therapy

The Effects of Estrogen Replacement Therapy in Postmenopausal Women With Hypercalciuria and Low Bone Mass

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ClinicalTrials.gov Identifier: NCT01928082
Recruitment Status : Terminated (The fellow conducting the recruitment and screening left the institution)
First Posted : August 23, 2013
Results First Posted : March 7, 2018
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Hypercalciuria
Hypercalciuria, Familial Idiopathic
Osteopenia
Osteoporosis
Intervention: Drug: Transdermal estradiol

  Participant Flow

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
Transdermal Estradiol

Transdermal estradiol 0.05 mg/day for 4 weeks, followed by 0.10 mg/day for 4 weeks

Transdermal estradiol: 4 weeks of Vivelle-Dot 0.05 mg/day followed by 4 weeks of Vivelle-Dot 0.10 mg/day


Participant Flow:   Overall Study
    Transdermal Estradiol
STARTED   1 
COMPLETED   0 
NOT COMPLETED   1 
Study terminated.                1 



  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.
data were not collected

Reporting Groups
  Description
Transdermal Estradiol

Transdermal estradiol 0.05 mg/day for 4 weeks, followed by 0.10 mg/day for 4 weeks

Transdermal estradiol: 4 weeks of Vivelle-Dot 0.05 mg/day followed by 4 weeks of Vivelle-Dot 0.10 mg/day


Baseline Measures
   Transdermal Estradiol 
Overall Participants Analyzed 
[Units: Participants]
 0 
Age [1]    
[1] Study terminated
Sex: Female, Male [1]    
[1] Study terminated.
Race and Ethnicity Not Collected [1]    
[1] Race and Ethnicity were not collected from any participant.


  Outcome Measures

1.  Primary:   Absolute Change in 24 Hour Urinary Calcium Excretion   [ Time Frame: 4 weeks, 8 weeks ]

2.  Secondary:   Serum 1,25-dihydroxyvitamin D3   [ Time Frame: 4 weeks, 8 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Serum Bone Morphogenetic Protein 2   [ Time Frame: 4 weeks, 8 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Serum Sclerostin   [ Time Frame: 4 weeks, 8 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Other Pre-specified:   Serum Estradiol   [ Time Frame: 4 weeks, 8 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Other Pre-specified:   Serum Total Calcium   [ Time Frame: 4 weeks, 8 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Other Pre-specified:   Calculated Serum Ionized Calcium   [ Time Frame: 4 weeks, 8 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Other Pre-specified:   Calculated Tubular Resorption of Calcium   [ Time Frame: 4 weeks, 8 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

9.  Other Pre-specified:   Serum 25 Hydroxyvitamin D   [ Time Frame: 4 weeks, 8 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

10.  Other Pre-specified:   Serum Parathyroid Hormone   [ Time Frame: 4 weeks, 8 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

11.  Other Pre-specified:   Serum Phosphorus   [ Time Frame: 4 weeks, 8 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

12.  Other Pre-specified:   Serum Osteocalcin   [ Time Frame: 4 weeks, 8 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

13.  Other Pre-specified:   Serum Bone-specific Alkaline Phosphatase   [ Time Frame: 4 weeks, 8 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

14.  Other Pre-specified:   Serum C-telopeptides of Type 1 Collagen   [ Time Frame: 4 weeks, 8 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

15.  Other Pre-specified:   Serum Procollagen Type 1 N-terminal Propeptide   [ Time Frame: 4 weeks, 8 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
Early termination leading to 0 subjects analyzed


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Murray J. Favus
Organization: The University of Chicago
phone: (773) 702-6138
e-mail: mfavus@medicine.bsd.uchicago.edu


Publications:


Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01928082     History of Changes
Other Study ID Numbers: 12-0062
First Submitted: August 20, 2013
First Posted: August 23, 2013
Results First Submitted: October 12, 2017
Results First Posted: March 7, 2018
Last Update Posted: March 7, 2018