Trial Outcomes & Findings for Bone Microarchitecture in Osteopenic Postmenopausal Women (NCT NCT00577395)
NCT ID: NCT00577395
Last Updated: 2013-04-22
Results Overview
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.
TERMINATED
PHASE4
13 participants
12 months
2013-04-22
Participant Flow
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.
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.
Participant milestones
| Measure |
One 150 mg Risedronate Once a Month
one 150 mg risedronate once a month, orally
|
Placebo Tablet Once a Month
Placebo tablet once a month, orally
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
Reasons for withdrawal
| Measure |
One 150 mg Risedronate Once a Month
one 150 mg risedronate once a month, orally
|
Placebo Tablet Once a Month
Placebo tablet once a month, orally
|
|---|---|---|
|
Overall Study
Study was terminated early by Sponsor
|
7
|
6
|
Baseline Characteristics
Bone Microarchitecture in Osteopenic Postmenopausal Women
Baseline characteristics by cohort
| Measure |
One 150 mg Risedronate Once a Month
n=7 Participants
one 150 mg risedronate once a month, orally
|
Placebo Tablet Once a Month
n=6 Participants
Placebo tablet once a month, orally
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
51.42 years
STANDARD_DEVIATION 2.50 • n=5 Participants
|
53.83 years
STANDARD_DEVIATION 2.63 • n=7 Participants
|
52.53 years
STANDARD_DEVIATION 2.75 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Study was terminated prior to acquiring any efficacy endpoints. No efficacy analyses were performed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: Study was terminated prior to acquiring any efficacy endpoints. No efficacy analyses were performed.
Study was terminated prior to acquiring any efficacy endpoints. No efficacy analyses were performed.
Outcome measures
Outcome data not reported
Adverse Events
One 150 mg Risedronate Once a Month
Placebo Tablet Once a Month
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
One 150 mg Risedronate Once a Month
n=7 participants at risk
one 150 mg risedronate once a month, orally
|
Placebo Tablet Once a Month
n=6 participants at risk
Placebo tablet once a month, orally
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/7 • From the point of study enrolment until the subject's last observation.
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.
|
16.7%
1/6 • Number of events 1 • From the point of study enrolment until the subject's last observation.
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.
|
|
General disorders
Pharyngitis
|
0.00%
0/7 • From the point of study enrolment until the subject's last observation.
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.
|
16.7%
1/6 • Number of events 1 • From the point of study enrolment until the subject's last observation.
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.
|
|
Cardiac disorders
Blood pressure increased
|
14.3%
1/7 • Number of events 1 • From the point of study enrolment until the subject's last observation.
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.
|
0.00%
0/6 • From the point of study enrolment until the subject's last observation.
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.
|
|
Infections and infestations
Ear infection
|
14.3%
1/7 • Number of events 1 • From the point of study enrolment until the subject's last observation.
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.
|
0.00%
0/6 • From the point of study enrolment until the subject's last observation.
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.
|
Additional Information
Grexan Wulff, Manager Regulatory Affairs
Warner Chilcott
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER