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Trial record 5 of 75 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 : December 10, 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
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Transdermal Estradiol
Hide Arm/Group Description

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

Period Title: Overall Study
Started 1
Completed 0
Not Completed 1
Reason Not Completed
Study terminated.             1
Arm/Group Title Transdermal Estradiol
Hide Arm/Group Description

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

Overall Number of Baseline Participants 0
Hide Baseline Analysis Population Description
data were not collected
Age, Continuous   [1] 
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Study terminated
Sex: Female, Male   [1] 
Number Analyzed 0 participants
Female
Male
[1]
Measure Analysis Population Description: Study terminated.
Race and Ethnicity Not Collected   [1] 
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Absolute Change in 24 Hour Urinary Calcium Excretion
Hide Description 0 participants were measured because the study was terminated
Time Frame 4 weeks, 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
0 participants were analyzed because the study was terminated
Arm/Group Title Transdermal Estradiol
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Serum 1,25-dihydroxyvitamin D3
Hide Description 0 participants were analyzed because the study was terminated
Time Frame 4 weeks, 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The study was terminated
Arm/Group Title Transdermal Estradiol
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Serum Bone Morphogenetic Protein 2
Hide Description Not available because the study was terminated
Time Frame 4 weeks, 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
the study was terminated
Arm/Group Title Transdermal Estradiol
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Serum Sclerostin
Hide Description Not available because the study was terminated
Time Frame 4 weeks, 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not available because the study was terminated
Arm/Group Title Transdermal Estradiol
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Other Pre-specified Outcome
Title Serum Estradiol
Hide Description Not available because the study was terminated
Time Frame 4 weeks, 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not available because the study was terminated
Arm/Group Title Transdermal Estradiol
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Other Pre-specified Outcome
Title Serum Total Calcium
Hide Description Not available because the study was terminated
Time Frame 4 weeks, 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not available because the study was terminated
Arm/Group Title Transdermal Estradiol
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Other Pre-specified Outcome
Title Calculated Serum Ionized Calcium
Hide Description Not available because the study was terminated
Time Frame 4 weeks, 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not available because the study was terminated
Arm/Group Title Transdermal Estradiol
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Other Pre-specified Outcome
Title Calculated Tubular Resorption of Calcium
Hide Description Not available because the study was terminated
Time Frame 4 weeks, 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not available because the study was terminated
Arm/Group Title Transdermal Estradiol
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
9.Other Pre-specified Outcome
Title Serum 25 Hydroxyvitamin D
Hide Description Not available because the study was terminated
Time Frame 4 weeks, 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not available because the study was terminated
Arm/Group Title Transdermal Estradiol
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
10.Other Pre-specified Outcome
Title Serum Parathyroid Hormone
Hide Description Not available because the study was terminated
Time Frame 4 weeks, 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not available because the study was terminated
Arm/Group Title Transdermal Estradiol
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
11.Other Pre-specified Outcome
Title Serum Phosphorus
Hide Description Not available because the study was terminated
Time Frame 4 weeks, 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not available because the study was terminated
Arm/Group Title Transdermal Estradiol
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
12.Other Pre-specified Outcome
Title Serum Osteocalcin
Hide Description Not available because the study was terminated
Time Frame 4 weeks, 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not available because the study was terminated
Arm/Group Title Transdermal Estradiol
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
13.Other Pre-specified Outcome
Title Serum Bone-specific Alkaline Phosphatase
Hide Description Not available because the study was terminated
Time Frame 4 weeks, 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not available because the study was terminated
Arm/Group Title Transdermal Estradiol
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
14.Other Pre-specified Outcome
Title Serum C-telopeptides of Type 1 Collagen
Hide Description Not available because the study was terminated
Time Frame 4 weeks, 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not available because the study was terminated
Arm/Group Title Transdermal Estradiol
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
15.Other Pre-specified Outcome
Title Serum Procollagen Type 1 N-terminal Propeptide
Hide Description It is not available because the study was terminated
Time Frame 4 weeks, 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not available because the study was terminated
Arm/Group Title Transdermal Estradiol
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description The study was not finished and adverse events were not collected
 
Arm/Group Title Transdermal Estradiol
Hide Arm/Group Description

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

All-Cause Mortality
Transdermal Estradiol
Affected / at Risk (%)
Total   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
Transdermal Estradiol
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Transdermal Estradiol
Affected / at Risk (%)
Total   0/0 
Early termination leading to 0 subjects analyzed
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
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: December 10, 2018