Trial · NCT00129623

A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia

NCT00129623, Phase 4, Completed, Hoffmann-La Roche; results first posted 2016-01-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia. Trials, record NCT00129623. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00129623

On this page

Trial

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

Title: A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia
NCT number: NCT00129623
Status: Completed
Phases: Phase 4
Enrollment: 160 participants, actual
Lead sponsor: Hoffmann-La Roche
Conditions: Post-Menopausal Osteopenia
Interventions: Placebo, ibandronate [Bonviva/Boniva]
First posted: 2005-08-12
Last updated: 2016-01-11
Results first posted: 2016-01-11

Source ClinicalTrials.gov

Registered outcomes9

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

List	Outcome	Time frame	Description
Primary	Relative Change From Baseline in Mean Bone Mineral Density (BMD) of the Lumbar Spine (L2 to L4) at Month 12	Baseline and Month 12	BMD was measured by a single dual-energy x-ray absorptiometry (DEXA) scan of the lumbar spine at the time of screening and at Month 12. A BMD measurement was considered unsuitable in case of detection of a fracture, an osteoarthritic process, or a scanning artifact that could not be removed to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center. The change in BMD was defined as the relative difference between the last individual measurement available at 12 months and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year - BMD at baseline) / (BMD at baseline)
Secondary	Absolute Change From Baseline in Mean Lumbar Spine BMD at Month 12	Baseline and Month 12	BMD was measured by a single dual-energy x-ray absorptiometry (DEXA) scan of the lumbar spine at the time of screening and at Month 12. A BMD measurement was considered unsuitable in case of detection of a fracture, an osteoarthritic process, or a scanning artifact that could not be removed to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center. The absolute change from Baseline in mean BMD of the lumbar spine (L2-L4) was measured as g/cm\^2 and summarized using descriptive statistics.
Secondary	Relative Change From Baseline in Mean Proximal Femur BMD at Month 12	Baseline and Month 12	BMD was measured by a single DEXA scan of the proximal femur at the time of screening and at Month 12. The relative (%) change from Baseline in BMD of the proximal femur (total hip, trochanter, femoral neck) at Month 12 was summarized using descriptive statistics. BMD of fractured bones that could impact the scan area were not taken into account.
Secondary	Absolute Change From Baseline in BMD of the Proximal Femur at Month 12	Baseline and Month 12	BMD was measured by a single DEXA scan of the proximal femur at the time of screening and at Month 12. The absolute change from baseline in BMD of the proximal femur (total hip, trochanter, femoral neck) at Month 12 was summarized using descriptive statistics. BMD of fractured bones that could impact the scan area were not taken into account.
Secondary	Relative Change From Baseline in Serum C-telopeptide Crosslinks of Type 1 Collagen (CTX)	Baseline and 3, 6 and 12 months	Fasting blood samples were collected from participants for analysis of serum CTX (sCTX), which is a biochemical marker of bone resorption. Relative change from baseline of sCTX after 3, 6, and 12 months of treatment was summarized using descriptive statistics.
Secondary	Absolute Change From Baseline in sCTX	Baseline and 3, 6, 12 months	Fasting blood samples were collected from participants for analysis of sCTX, which is a biochemical marker of bone resorption. Absolute change from baseline of sCTX after 3, 6, and 12 months of treatment was summarized using descriptive statistics.
Secondary	Percentage of Responders	Up to 12 months	Percent responders were defined as follows: Participants with a) lumbar spine (LS) BMD, equal to or above Baseline at Month 12 b) proximal femur BMD, equal to or above Baseline at Month 12 c) Both lumbar spine and proximal femur BMD, equal or above Baseline at Month 12. BMD of the lumbar spine was defined as the BMD of at least two vertebrae (L2-L4) that were not fractured and not affected by an osteoarthritic process, or a scanning artifact that could not be removed to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center. Proximal femur included total hip, trochanter and femoral neck sites.
Secondary	Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)	Up to 15 days after end of study treatment (Approximately 2 years)	An AE is any untoward medical occurrence in a participant who is administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
Secondary	Number of Participants With Marked Laboratory Abnormalities	Screening up to 12 months	Blood for laboratory tests was taken at screening and immediately before participants received their monthly study medication at months 3, 6, and 12. The laboratory tests included: Hematology \[white blood cells (WBCs), platelets, hematocrit, and hemoglobin\] and Chemistry \[albumin, creatinine, blood urea nitrogen (BUN), alanine aminotransferase (ALT), total calcium, 25-hydroxy vitamin D, phosphate, magnesium, sodium, potassium, and chloride\].

Source ClinicalTrials.gov

Outcomes9

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Relative Change From Baseline in Mean Bone Mineral Density (BMD) of the Lumbar Spine (L2 to L4) at Month 12	Baseline and Month 12	The ITT population included participants who were randomized, received at least one dose of the trial medication and had baseline and at least one follow-up evaluation data point.	Percentage	LEAST_SQUARES_MEAN
SECONDARY	Absolute Change From Baseline in Mean Lumbar Spine BMD at Month 12	Baseline and Month 12	The ITT population included participants who were randomized, received at least one dose of the trial medication and had baseline and at least one follow-up evaluation data point.	g/cm^2	MEAN
SECONDARY	Relative Change From Baseline in Mean Proximal Femur BMD at Month 12	Baseline and Month 12	The ITT population included participants who were randomized, received at least one dose of the trial medication and had baseline and at least one follow-up evaluation data point.	Percentage	MEAN
SECONDARY	Absolute Change From Baseline in BMD of the Proximal Femur at Month 12	Baseline and Month 12	The ITT population included participants who were randomized, received at least one dose of the trial medication and had baseline and at least one follow-up evaluation data point.	g/cm^2	MEAN
SECONDARY	Relative Change From Baseline in Serum C-telopeptide Crosslinks of Type 1 Collagen (CTX)	Baseline and 3, 6 and 12 months	The ITT population included participants who were randomized, received at least one dose of the trial medication and had baseline and at least one follow-up evaluation data point. n = the number of participants analyzed at a given time point.	Percentage	MEDIAN
SECONDARY	Absolute Change From Baseline in sCTX	Baseline and 3, 6, 12 months	The ITT population included participants who were randomized, received at least one dose of the trial medication and had baseline and at least one follow-up evaluation data point. n = the number of participants analyzed at a given time point.	ng/ml	MEDIAN
SECONDARY	Percentage of Responders	Up to 12 months	The ITT population included participants who were randomized, received at least one dose of the trial medication and had baseline and at least one follow-up evaluation data point.	Percentage	NUMBER
SECONDARY	Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)	Up to 15 days after end of study treatment (Approximately 2 years)	The safety population included participants who had at least one dose of the trial medication documented in the CRF whether withdrawn prematurely or not.	participants	NUMBER
SECONDARY	Number of Participants With Marked Laboratory Abnormalities	Screening up to 12 months	The safety population included participants who had at least one dose of the trial medication documented in the CRF whether withdrawn prematurely or not.	participants	NUMBER

Source ClinicalTrials.gov

Results by group44

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

Outcome	Group	Category	Value	Spread	Units
Relative Change From Baseline in Mean Bone Mineral Density (BMD) of the Lumbar Spine (L2 to L4) at Month 12	Placebo		-0.3941	Standard Error 0.4148	Percentage
Relative Change From Baseline in Mean Bone Mineral Density (BMD) of the Lumbar Spine (L2 to L4) at Month 12	Ibandronate (IBN) 150 mg Monthly		3.7285	Standard Error 0.4229	Percentage
Absolute Change From Baseline in Mean Lumbar Spine BMD at Month 12	Placebo		-0.0039	Standard Deviation 0.0319	g/cm^2
Absolute Change From Baseline in Mean Lumbar Spine BMD at Month 12	Ibandronate (IBN) 150 mg Monthly		0.0322	Standard Deviation 0.0315	g/cm^2
Relative Change From Baseline in Mean Proximal Femur BMD at Month 12	Placebo	Total hip	-0.9265	Standard Deviation 1.8790	Percentage
Relative Change From Baseline in Mean Proximal Femur BMD at Month 12	Ibandronate (IBN) 150 mg Monthly	Total hip	1.4855	Standard Deviation 2.1862	Percentage
Relative Change From Baseline in Mean Proximal Femur BMD at Month 12	Placebo	Trochanter	-0.9120	Standard Deviation 3.0025	Percentage
Relative Change From Baseline in Mean Proximal Femur BMD at Month 12	Ibandronate (IBN) 150 mg Monthly	Trochanter	2.8688	Standard Deviation 3.0906	Percentage
Relative Change From Baseline in Mean Proximal Femur BMD at Month 12	Placebo	Femoral Neck	-0.7537	Standard Deviation 3.7743	Percentage
Relative Change From Baseline in Mean Proximal Femur BMD at Month 12	Ibandronate (IBN) 150 mg Monthly	Femoral Neck	1.0930	Standard Deviation 2.6466	Percentage

1 to 10 of 44Source ClinicalTrials.gov

See all 44 results by group

Participant flow8

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	83
Overall Study	STARTED	Ibandronate (IBN) 150 mg Monthly	77
Overall Study	Intent-to-treat (ITT)/ Safety Population	Placebo	83
Overall Study	Intent-to-treat (ITT)/ Safety Population	Ibandronate (IBN) 150 mg Monthly	77
Overall Study	COMPLETED	Placebo	73
Overall Study	COMPLETED	Ibandronate (IBN) 150 mg Monthly	65
Overall Study	NOT COMPLETED	Placebo	10
Overall Study	NOT COMPLETED	Ibandronate (IBN) 150 mg Monthly	12

Source ClinicalTrials.gov

Adverse events38

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	8	82
other	Arthralgia	Musculoskeletal and connective tissue disorders	Ibandronate (IBN) 150 mg Monthly	12	76
other	Pain in extremity	Musculoskeletal and connective tissue disorders	Placebo	5	82
other	Pain in extremity	Musculoskeletal and connective tissue disorders	Ibandronate (IBN) 150 mg Monthly	5	76
other	Back pain	Musculoskeletal and connective tissue disorders	Placebo	5	82
other	Back pain	Musculoskeletal and connective tissue disorders	Ibandronate (IBN) 150 mg Monthly	2	76
other	Myalgia	Musculoskeletal and connective tissue disorders	Placebo	2	82
other	Myalgia	Musculoskeletal and connective tissue disorders	Ibandronate (IBN) 150 mg Monthly	5	76
other	Upper respiratory tract infection	Infections and infestations	Placebo	12	82
other	Upper respiratory tract infection	Infections and infestations	Ibandronate (IBN) 150 mg Monthly	6	76

1 to 10 of 38Source ClinicalTrials.gov

See all 38 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 (IBN) 150 mg Monthly
Total, other adverse events	Placebo	41	82
Total, other adverse events	Ibandronate (IBN) 150 mg Monthly	40	76
Total, serious adverse events	Placebo	1	83
Total, serious adverse events	Ibandronate (IBN) 150 mg Monthly	3	77

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 (IBN) 150 mg Monthly 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.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00129623

GET https://conductscience.org/api/trials/v1/NCT00129623/results?page=2

API reference For AI assistants