Trial Outcomes & Findings for The Effect Of Oral Ibandronate In Male Osteoporosis (NCT NCT00397839)
NCT ID: NCT00397839
Last Updated: 2009-12-21
Results Overview
BMD will be assessed using an analysis of covariance model (ANCOVA) with datea obtained from dual-Energy X-ray absorptiometry scans.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
135 participants
Primary outcome timeframe
12 months
Results posted on
2009-12-21
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo orally at a dose of 150 mg once a month for 12 months
|
Ibandronate
Ibandronate orally at a dose of 150 mg once a month for 12 months
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
87
|
|
Overall Study
COMPLETED
|
41
|
69
|
|
Overall Study
NOT COMPLETED
|
7
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect Of Oral Ibandronate In Male Osteoporosis
Baseline characteristics by cohort
| Measure |
Placebo
n=47 Participants
Placebo orally at a dose of 150 mg once a month for 12 months
|
Ibandronate
n=85 Participants
Ibandronate orally at a dose of 150 mg once a month for 12 months
|
Total
n=132 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 65 years
|
23 participants
n=5 Participants
|
42 participants
n=7 Participants
|
65 participants
n=5 Participants
|
|
Age, Customized
>= 65 years
|
24 participants
n=5 Participants
|
43 participants
n=7 Participants
|
67 participants
n=5 Participants
|
|
Age Continuous
|
65.0 years
STANDARD_DEVIATION 10.63 • n=5 Participants
|
63.9 years
STANDARD_DEVIATION 11.20 • n=7 Participants
|
64.3 years
STANDARD_DEVIATION 10.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Intent-to-treat population. Includes participants with measurements at Baseline and Month 12.
BMD will be assessed using an analysis of covariance model (ANCOVA) with datea obtained from dual-Energy X-ray absorptiometry scans.
Outcome measures
| Measure |
Placebo
n=42 Participants
Placebo orally at a dose of 150 mg once a month for 12 months
|
Ibandronate
n=77 Participants
Ibandronate orally at a dose of 150 mg once a month for 12 months
|
|---|---|---|
|
Mean Percent Change in BMD of the Lumbar Spine From Baseline to Month 12
|
.94 percent
Standard Error 0.709
|
3.52 percent
Standard Error 0.661
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Intent-to-treat population. Includes patients with measurements at Baseline and Month 6.
BMD will be assessed using an analysis of covariance model (ANCOVA) with datea obtained from dual-Energy X-ray absorptiometry scans.
Outcome measures
| Measure |
Placebo
n=41 Participants
Placebo orally at a dose of 150 mg once a month for 12 months
|
Ibandronate
n=77 Participants
Ibandronate orally at a dose of 150 mg once a month for 12 months
|
|---|---|---|
|
Mean Percent Change in BMD of the Lumbar Spine From Baseline to Month 6
|
0.78 percent
Standard Error 0.649
|
1.64 percent
Standard Error 0.604
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intent-to-treat population. Includes patients with measurements at Baseline and Month 12.
BMD will be assessed using an analysis of covariance model (ANCOVA) with datea obtained from dual-Energy X-ray absorptiometry scans.
Outcome measures
| Measure |
Placebo
n=42 Participants
Placebo orally at a dose of 150 mg once a month for 12 months
|
Ibandronate
n=77 Participants
Ibandronate orally at a dose of 150 mg once a month for 12 months
|
|---|---|---|
|
Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 12
Total Hip
|
-0.31 percent
Standard Error 0.473
|
1.82 percent
Standard Error 0.430
|
|
Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 12
Femoral Neck
|
-0.23 percent
Standard Error 0.663
|
1.21 percent
Standard Error 0.612
|
|
Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 12
Trochanter
|
0.43 percent
Standard Error 0.692
|
2.15 percent
Standard Error 0.633
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Intent-to-treat population. Includes patients with measurements at Baseline and Month 6.
BMD will be assessed using an analysis of covariance model (ANCOVA) with datea obtained from dual-Energy X-ray absorptiometry scans.
Outcome measures
| Measure |
Placebo
n=41 Participants
Placebo orally at a dose of 150 mg once a month for 12 months
|
Ibandronate
n=77 Participants
Ibandronate orally at a dose of 150 mg once a month for 12 months
|
|---|---|---|
|
Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 6
Total Hip
|
-0.48 percent
Standard Error 0.386
|
1.27 percent
Standard Error 0.349
|
|
Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 6
Femoral Neck
|
-0.22 percent
Standard Error 0.630
|
0.96 percent
Standard Error 0.580
|
|
Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 6
Trochanter
|
0.55 percent
Standard Error 0.677
|
2.59 percent
Standard Error 0.616
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intent-to-treat population
Responders are defined as participants who have BMD values \>= their baseline values at Months 6 and 12, and not any pre-defined percentage increase in BMD values of clinical significance.
Outcome measures
| Measure |
Placebo
n=47 Participants
Placebo orally at a dose of 150 mg once a month for 12 months
|
Ibandronate
n=85 Participants
Ibandronate orally at a dose of 150 mg once a month for 12 months
|
|---|---|---|
|
Responder Rate of Subjects Who Remained the Same or Had Any Improvement in BMD (>= Baseline) at 6 Months and 12 Months
Month 6: Lumbar Spine
|
30 participants
|
62 participants
|
|
Responder Rate of Subjects Who Remained the Same or Had Any Improvement in BMD (>= Baseline) at 6 Months and 12 Months
Month 6: Total Hip
|
14 participants
|
57 participants
|
|
Responder Rate of Subjects Who Remained the Same or Had Any Improvement in BMD (>= Baseline) at 6 Months and 12 Months
Month 6: Lumbar Spine and Total Hip
|
10 participants
|
46 participants
|
|
Responder Rate of Subjects Who Remained the Same or Had Any Improvement in BMD (>= Baseline) at 6 Months and 12 Months
Month 12: Lumbar Spine
|
33 participants
|
71 participants
|
|
Responder Rate of Subjects Who Remained the Same or Had Any Improvement in BMD (>= Baseline) at 6 Months and 12 Months
Month 12: Total Hip
|
20 participants
|
64 participants
|
|
Responder Rate of Subjects Who Remained the Same or Had Any Improvement in BMD (>= Baseline) at 6 Months and 12 Months
Month 12: Lumbar Spine and Total Hip
|
16 participants
|
59 participants
|
Adverse Events
Placebo
Serious events: 6 serious events
Other events: 13 other events
Deaths: 0 deaths
Ibandronate
Serious events: 7 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=47 participants at risk
Placebo orally at a dose of 150 mg once a month for 12 months
|
Ibandronate
n=86 participants at risk
Ibandronate orally at a dose of 150 mg once a month for 12 months
|
|---|---|---|
|
General disorders
Death
|
0.00%
0/47
Safety analysis population
|
1.2%
1/86
Safety analysis population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
2.1%
1/47
Safety analysis population
|
0.00%
0/86
Safety analysis population
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
2.1%
1/47
Safety analysis population
|
0.00%
0/86
Safety analysis population
|
|
Nervous system disorders
Syncope
|
0.00%
0/47
Safety analysis population
|
2.3%
2/86
Safety analysis population
|
|
Nervous system disorders
Multiple sclerosis
|
2.1%
1/47
Safety analysis population
|
0.00%
0/86
Safety analysis population
|
|
Infections and infestations
Localised Infection
|
2.1%
1/47
Safety analysis population
|
0.00%
0/86
Safety analysis population
|
|
Infections and infestations
Pneumonia
|
0.00%
0/47
Safety analysis population
|
1.2%
1/86
Safety analysis population
|
|
Eye disorders
Retinal detachment
|
0.00%
0/47
Safety analysis population
|
1.2%
1/86
Safety analysis population
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/47
Safety analysis population
|
1.2%
1/86
Safety analysis population
|
|
General disorders
Chest Pain
|
2.1%
1/47
Safety analysis population
|
0.00%
0/86
Safety analysis population
|
|
Injury, poisoning and procedural complications
Pneumoconiosis
|
0.00%
0/47
Safety analysis population
|
1.2%
1/86
Safety analysis population
|
|
Renal and urinary disorders
Renal failure actue
|
2.1%
1/47
Safety analysis population
|
0.00%
0/86
Safety analysis population
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.1%
1/47
Safety analysis population
|
0.00%
0/86
Safety analysis population
|
|
Vascular disorders
Hypotension
|
2.1%
1/47
Safety analysis population
|
0.00%
0/86
Safety analysis population
|
Other adverse events
| Measure |
Placebo
n=47 participants at risk
Placebo orally at a dose of 150 mg once a month for 12 months
|
Ibandronate
n=86 participants at risk
Ibandronate orally at a dose of 150 mg once a month for 12 months
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.6%
5/47
Safety analysis population
|
5.8%
5/86
Safety analysis population
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.4%
3/47
Safety analysis population
|
4.7%
4/86
Safety analysis population
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/47
Safety analysis population
|
8.1%
7/86
Safety analysis population
|
|
Gastrointestinal disorders
Constipation
|
4.3%
2/47
Safety analysis population
|
2.3%
2/86
Safety analysis population
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/47
Safety analysis population
|
4.7%
4/86
Safety analysis population
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.3%
2/47
Safety analysis population
|
2.3%
2/86
Safety analysis population
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection
|
2.1%
1/47
Safety analysis population
|
3.5%
3/86
Safety analysis population
|
Additional Information
Medical Communications
Hoffmann-La Roche
Phone: 800-821-8590
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place