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Trial record 71 of 108 for:    Risedronate

Bone Microarchitecture in Osteopenic Postmenopausal Women

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ClinicalTrials.gov Identifier: NCT00577395
Recruitment Status : Terminated
First Posted : December 20, 2007
Results First Posted : December 22, 2009
Last Update Posted : April 22, 2013
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Warner Chilcott

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Osteoporosis
Interventions Drug: placebo
Drug: risedronate
Enrollment 13
Recruitment Details Beginning with the first patient screened on June 18th, 2008, a total of 51 patients were screened for inclusion into the study, of which 38 were excluded from further participation.
Pre-assignment Details The Screening visit was conducted within 45 days of randomization. After obtaining written informed consent, patients underwent a preliminary screening, including Dual Energy X-ray Absorptiometry (DXA) of the lumbar spine and proximal femur. The most frequent reason for screening failure was DXA results.
Arm/Group Title One 150 mg Risedronate Once a Month Placebo Tablet Once a Month
Hide Arm/Group Description one 150 mg risedronate once a month, orally Placebo tablet once a month, orally
Period Title: Overall Study
Started 7 [1] 6 [2]
Completed 0 [3] 0 [3]
Not Completed 7 6
Reason Not Completed
Study was terminated early by Sponsor             7             6
[1]
67 planned for Treatment 2, but due to enrollment difficulties this was not met.
[2]
67 were planned for Treatment 1, but due to enrollment difficulties this was not met.
[3]
The study was terminated early by the Sponsor for lack of enrollment
Arm/Group Title One 150 mg Risedronate Once a Month Placebo Tablet Once a Month Total
Hide Arm/Group Description one 150 mg risedronate once a month, orally Placebo tablet once a month, orally Total of all reporting groups
Overall Number of Baseline Participants 7 6 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 13 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
 100.0%
6
 100.0%
13
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 6 participants 13 participants
51.42  (2.50) 53.83  (2.63) 52.53  (2.75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 13 participants
Female
7
 100.0%
6
 100.0%
13
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 13 participants
United States 5 3 8
Argentina 2 3 5
1.Primary Outcome
Title Percent Change From Baseline in Erosion Index (A Ratio of Curve-like Structures to Plate-like Structures and is a Measure of the Degree of Structural Degradation) of the Distal Radius
Hide Description

The percent was change from baseline in erosion index at the distal radius between the risedronate and placebo groups at Month 12 (the lower the percent change in erosion index, the greater the improvement of structural degradation); the last valid postbaseline measurement was to be used when the Month 12 value was missing (Last Observation Carried Forward or LOCF).

NOTE: The study was unable to recruit sufficient numbers of patients to meet with the protocol specified numbers, thus it was terminated early after 5 months. No efficacy analyses were performed.

Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated prior to acquiring any efficacy endpoints. No efficacy analyses were performed.
Arm/Group Title One 150 mg Risedronate Once a Month Placebo Tablet Once a Month
Hide Arm/Group Description:
one 150 mg risedronate once a month, orally
Placebo tablet once a month, orally
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Erosion Index of the Distal Radius
Hide Description Study was terminated prior to acquiring any efficacy endpoints. No efficacy analyses were performed.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated prior to acquiring any efficacy endpoints. No efficacy analyses were performed.
Arm/Group Title One 150 mg Risedronate Once a Month Placebo Tablet Once a Month
Hide Arm/Group Description:
one 150 mg risedronate once a month, orally
Placebo tablet once a month, orally
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame From the point of study enrolment until the subject's last observation.
Adverse Event Reporting Description Specific safety parameters and procedures were to include vital signs, serum chemistry panel/hematology/urinalysis, and recording of AEs, including moderate-to-severe upper GI events and clinical fractures.
 
Arm/Group Title One 150 mg Risedronate Once a Month Placebo Tablet Once a Month
Hide Arm/Group Description one 150 mg risedronate once a month, orally Placebo tablet once a month, orally
All-Cause Mortality
One 150 mg Risedronate Once a Month Placebo Tablet Once a Month
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
One 150 mg Risedronate Once a Month Placebo Tablet Once a Month
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/7 (0.00%)      0/6 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
One 150 mg Risedronate Once a Month Placebo Tablet Once a Month
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/7 (28.57%)      2/6 (33.33%)    
Cardiac disorders     
Blood pressure increased * 3  1/7 (14.29%)  1 0/6 (0.00%)  0
Gastrointestinal disorders     
Abdominal distension * 1  0/7 (0.00%)  0 1/6 (16.67%)  1
General disorders     
Pharyngitis * 2  0/7 (0.00%)  0 1/6 (16.67%)  1
Infections and infestations     
Ear infection * 4  1/7 (14.29%)  1 0/6 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, Abdominal distension
2
Term from vocabulary, Pharyngitis
3
Term from vocabulary, Blood pressure incre
4
Term from vocabulary, Ear infection
NOTE: The study was terminated early (after 5 months), prior to acquiring any efficacy endpoints; consequently, NO subject efficacy analyses were performed
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 Study Site and Principal Investigator agree that all data, calculations, interpretations, opinions, and recommendations regarding the study will be the property of the Sponsor. The Study Site and Principal Investigator agree to consider the results as confidential information subject to use restrictions.

The names of the Investigator(s) will not be used by P&GP for commercial purposes without appropriate written permission, unless required by law or government regulation.

Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Grexan Wulff, Manager Regulatory Affairs
Organization: Warner Chilcott
Phone: 973-442-3376
EMail: gwulff@wcrx.com
Layout table for additonal information
Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00577395     History of Changes
Other Study ID Numbers: 2007075
First Submitted: December 19, 2007
First Posted: December 20, 2007
Results First Submitted: November 18, 2009
Results First Posted: December 22, 2009
Last Update Posted: April 22, 2013