Trial · NCT00397839

The Effect Of Oral Ibandronate In Male Osteoporosis

NCT00397839, Phase 3, Completed, Hoffmann-La Roche; results first posted 2009-12-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. The Effect Of Oral Ibandronate In Male Osteoporosis. Trials, record NCT00397839. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00397839

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: The Effect Of Oral Ibandronate In Male Osteoporosis
NCT number: NCT00397839
Status: Completed
Phases: Phase 3
Enrollment: 135 participants, actual
Lead sponsor: Hoffmann-La Roche
Conditions: Male Osteoporosis
Interventions: Ibandronate, placebo
First posted: 2006-11-10
Last updated: 2009-12-21
Results first posted: 2009-12-21

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Mean Percent Change in BMD of the Lumbar Spine From Baseline to Month 12	12 months	BMD will be assessed using an analysis of covariance model (ANCOVA) with datea obtained from dual-Energy X-ray absorptiometry scans.
Secondary	Mean Percent Change in BMD of the Lumbar Spine From Baseline to Month 6	6 months	BMD will be assessed using an analysis of covariance model (ANCOVA) with datea obtained from dual-Energy X-ray absorptiometry scans.
Secondary	Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 12	12 months	BMD will be assessed using an analysis of covariance model (ANCOVA) with datea obtained from dual-Energy X-ray absorptiometry scans.
Secondary	Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 6	6 months	BMD will be assessed using an analysis of covariance model (ANCOVA) with datea obtained from dual-Energy X-ray absorptiometry scans.
Secondary	Responder Rate of Subjects Who Remained the Same or Had Any Improvement in BMD (>= Baseline) at 6 Months and 12 Months	12 months	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.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean Percent Change in BMD of the Lumbar Spine From Baseline to Month 12	12 months	Intent-to-treat population. Includes participants with measurements at Baseline and Month 12.	percent	LEAST_SQUARES_MEAN
SECONDARY	Mean Percent Change in BMD of the Lumbar Spine From Baseline to Month 6	6 months	Intent-to-treat population. Includes patients with measurements at Baseline and Month 6.	percent	LEAST_SQUARES_MEAN
SECONDARY	Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 12	12 months	Intent-to-treat population. Includes patients with measurements at Baseline and Month 12.	percent	LEAST_SQUARES_MEAN
SECONDARY	Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 6	6 months	Intent-to-treat population. Includes patients with measurements at Baseline and Month 6.	percent	LEAST_SQUARES_MEAN
SECONDARY	Responder Rate of Subjects Who Remained the Same or Had Any Improvement in BMD (>= Baseline) at 6 Months and 12 Months	12 months	Intent-to-treat population	participants	NUMBER

Source ClinicalTrials.gov

Results by group28

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Mean Percent Change in BMD of the Lumbar Spine From Baseline to Month 12	Placebo		.94	Standard Error 0.709	percent
Mean Percent Change in BMD of the Lumbar Spine From Baseline to Month 12	Ibandronate		3.52	Standard Error 0.661	percent
Mean Percent Change in BMD of the Lumbar Spine From Baseline to Month 6	Placebo		0.78	Standard Error 0.649	percent
Mean Percent Change in BMD of the Lumbar Spine From Baseline to Month 6	Ibandronate		1.64	Standard Error 0.604	percent
Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 12	Placebo	Total Hip	-0.31	Standard Error 0.473	percent
Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 12	Ibandronate	Total Hip	1.82	Standard Error 0.430	percent
Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 12	Placebo	Femoral Neck	-0.23	Standard Error 0.663	percent
Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 12	Ibandronate	Femoral Neck	1.21	Standard Error 0.612	percent
Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 12	Placebo	Trochanter	0.43	Standard Error 0.692	percent
Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 12	Ibandronate	Trochanter	2.15	Standard Error 0.633	percent

1 to 10 of 28Source ClinicalTrials.gov

See all 28 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	48
Overall Study	STARTED	Ibandronate	87
Overall Study	COMPLETED	Placebo	41
Overall Study	COMPLETED	Ibandronate	69
Overall Study	NOT COMPLETED	Placebo	7
Overall Study	NOT COMPLETED	Ibandronate	18

Source ClinicalTrials.gov

Adverse events42

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Arthralgia	Musculoskeletal and connective tissue disorders	Placebo	5	47
other	Arthralgia	Musculoskeletal and connective tissue disorders	Ibandronate	5	86
other	Back pain	Musculoskeletal and connective tissue disorders	Placebo	3	47
other	Back pain	Musculoskeletal and connective tissue disorders	Ibandronate	4	86
other	Nasopharyngitis	Infections and infestations	Placebo	0	47
other	Nasopharyngitis	Infections and infestations	Ibandronate	7	86
other	Constipation	Gastrointestinal disorders	Placebo	2	47
other	Constipation	Gastrointestinal disorders	Ibandronate	2	86
other	Nausea	Gastrointestinal disorders	Placebo	0	47
other	Nausea	Gastrointestinal disorders	Ibandronate	4	86

1 to 10 of 42Source ClinicalTrials.gov

See all 42 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Ibandronate
Total, other adverse events	Placebo	13	47
Total, other adverse events	Ibandronate	27	86
Total, serious adverse events	Placebo	6	47
Total, serious adverse events	Ibandronate	7	86

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Ibandronate vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

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