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Trial record 27 of 108 for:    Risedronate

Effect of Bisphosphonate on Bone Loss in Postmenopausal Women With Breast Cancer Initiating Aromatase Inhibitor Therapy (REBBeCA II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00485953
Recruitment Status : Completed
First Posted : June 13, 2007
Results First Posted : July 3, 2014
Last Update Posted : October 13, 2017
Sponsor:
Collaborator:
University of Pittsburgh
Information provided by (Responsible Party):
Susan L. Greenspan, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Conditions Bone Loss
Osteoporosis
Breast Cancer
Intervention Drug: risedronate
Enrollment 109
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Active Medication Group Placebo Group
Hide Arm/Group Description

risedronate 35 mg weekly

risedronate: risedronate 35 mg per week

Received placebo medication once per week
Period Title: Overall Study
Started 55 54
Completed 48 47
Not Completed 7 7
Arm/Group Title Active Medicine Group Placebo Group Total
Hide Arm/Group Description risedronate 35 mg weekly Received placebo medication once per week Total of all reporting groups
Overall Number of Baseline Participants 55 54 109
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 54 participants 109 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
32
  58.2%
34
  63.0%
66
  60.6%
>=65 years
23
  41.8%
20
  37.0%
43
  39.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 54 participants 109 participants
Female
55
 100.0%
54
 100.0%
109
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 54 participants 109 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   3.6%
1
   1.9%
3
   2.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
   9.1%
0
   0.0%
5
   4.6%
White
47
  85.5%
53
  98.1%
100
  91.7%
More than one race
1
   1.8%
0
   0.0%
1
   0.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 54 participants 109 participants
Hispanic or Latino
0
   0.0%
1
   1.9%
1
   0.9%
Not Hispanic or Latino
55
 100.0%
53
  98.1%
108
  99.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 55 participants 54 participants 109 participants
55 54 109
1.Primary Outcome
Title BMD of Spine by DXA
Hide Description BMD is the bone mineral density of the lumbar spine measured using the dual-energy x-ray absorptometry (DXA) scan.
Time Frame at 24 months
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Medicine Group Placebo Group
Hide Arm/Group Description:
risedronate 35 mg weekly
Received placebo medication once weekly
Overall Number of Participants Analyzed 55 54
Mean (Standard Error)
Unit of Measure: percentage change
2.269  (0.583) -1.735  (0.611)
2.Secondary Outcome
Title BMD by DXA at the Femoral Neck and Total Hip
Hide Description BMD is the bone mineral density of the femoral neck and total hip measured using the dual-energy x-ray absorptiometry (DXA) scan.
Time Frame at 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Medication Group Placebo Group
Hide Arm/Group Description:
risedronate 35 mg weekly
Placebo medication once weekly
Overall Number of Participants Analyzed 47 44
Mean (Standard Error)
Unit of Measure: percentage change
Total Hip BMD 0.558  (0.370) -2.748  (0.487)
Femoral Neck BMD 0.408  (0.607) -2.137  (0.628)
3.Secondary Outcome
Title Markers of Bone Resorption and Bone Formation
Hide Description [Not Specified]
Time Frame at 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Medicine Group Placebo Group
Hide Arm/Group Description:
risedronate 35 mg weekly
Received placebo medication once weekly
Overall Number of Participants Analyzed 48 47
Mean (Standard Error)
Unit of Measure: percentage change
CTX -14.906  (10.317) -4.077  (8.179)
P1NP -46.863  (3.025) -1.630  (5.732)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active Medicine Group Placebo Group
Hide Arm/Group Description risedronate 35 mg weekly Receive placebo medication once per week
All-Cause Mortality
Active Medicine Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Active Medicine Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/55 (18.18%)      16/54 (29.63%)    
Cardiac disorders     
Cardiovascular related events  5/55 (9.09%)  5 2/54 (3.70%)  2
Gastrointestinal disorders     
Gastrointestinal Events  0/55 (0.00%)  0 1/54 (1.85%)  1
General disorders     
Other events  0/55 (0.00%)  0 4/54 (7.41%)  4
Infections and infestations     
Infection related events  2/55 (3.64%)  2 3/54 (5.56%)  3
Musculoskeletal and connective tissue disorders     
Musculoskeletal related events  2/55 (3.64%)  2 5/54 (9.26%)  5
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Other cancers  0/55 (0.00%)  0 2/54 (3.70%)  2
Renal and urinary disorders     
Urogenital related events  0/55 (0.00%)  0 1/54 (1.85%)  1
Reproductive system and breast disorders     
Breast related events  1/55 (1.82%)  1 2/54 (3.70%)  2
Respiratory, thoracic and mediastinal disorders     
Respiratory related events  2/55 (3.64%)  2 0/54 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Active Medicine Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   52/55 (94.55%)      50/54 (92.59%)    
Cardiac disorders     
Cardiovascular related events  4/55 (7.27%)  4 10/54 (18.52%)  10
Endocrine disorders     
Endocrine related events  2/55 (3.64%)  2 4/54 (7.41%)  4
Gastrointestinal disorders     
Gastrointestinal related events  4/55 (7.27%)  4 12/54 (22.22%)  12
General disorders     
Other events  26/55 (47.27%)  26 26/54 (48.15%)  26
Infections and infestations     
Infection related events  13/55 (23.64%)  13 14/54 (25.93%)  14
Musculoskeletal and connective tissue disorders     
Musculoskeletal related events  27/55 (49.09%)  27 32/54 (59.26%)  32
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Other cancers  4/55 (7.27%)  4 1/54 (1.85%)  1
Renal and urinary disorders     
Urogenital related events  3/55 (5.45%)  3 6/54 (11.11%)  6
Reproductive system and breast disorders     
Breast related events  4/55 (7.27%)  4 3/54 (5.56%)  3
Respiratory, thoracic and mediastinal disorders     
Respiratory related events  2/55 (3.64%)  2 10/54 (18.52%)  10
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Susan Greenspan
Organization: University of Pittsburgh
Phone: 412-692-2476
EMail: greenspn@pitt.edu
Layout table for additonal information
Responsible Party: Susan L. Greenspan, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00485953     History of Changes
Other Study ID Numbers: PRO06080002 (REBBeCA II)
First Submitted: June 11, 2007
First Posted: June 13, 2007
Results First Submitted: June 2, 2014
Results First Posted: July 3, 2014
Last Update Posted: October 13, 2017