Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT00129623
Recruitment Status : Completed
First Posted : August 12, 2005
Results First Posted : January 11, 2016
Last Update Posted : January 11, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Post-Menopausal Osteopenia
Interventions Drug: Placebo
Drug: ibandronate [Bonviva/Boniva]
Enrollment 160
Recruitment Details This study was conducted at 10 centers in the United States.
Pre-assignment Details Of the 451 participants who were screened, 160 participants were randomly assigned to the two treatment arms (Placebo and Ibandronate). The major reason for screening failure was participants did not meet the Bone Mineral Density (BMD) entry criteria.
Arm/Group Title Placebo Ibandronate (IBN) 150 mg Monthly
Hide Arm/Group Description Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days. Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
Period Title: Overall Study
Started 83 77
Intent-to-treat (ITT)/ Safety Population 83 77
Completed 73 65
Not Completed 10 12
Reason Not Completed
Adverse Event             3             7
Refused Treatment             5             3
Failure to Return             1             1
Relocated job out of state             1             0
Uncertainty to return             0             1
Arm/Group Title Placebo Ibandronate (IBN) 150 mg Monthly Total
Hide Arm/Group Description Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days. Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days. Total of all reporting groups
Overall Number of Baseline Participants 83 77 160
Hide Baseline Analysis Population Description
Baseline characteristics are presented for the safety population which included participants who had at least one dose of the trial medication documented in the case report form (CRF) whether withdrawn prematurely or not.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 83 participants 77 participants 160 participants
53.4  (3.83) 53.7  (3.64) 53.5  (3.73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants 77 participants 160 participants
Female
83
 100.0%
77
 100.0%
160
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Relative Change From Baseline in Mean Bone Mineral Density (BMD) of the Lumbar Spine (L2 to L4) at Month 12
Hide Description 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)
Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Ibandronate (IBN) 150 mg Monthly
Hide Arm/Group Description:
Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
Overall Number of Participants Analyzed 70 68
Least Squares Mean (Standard Error)
Unit of Measure: Percentage
-0.3941  (0.4148) 3.7285  (0.4229)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ibandronate (IBN) 150 mg Monthly
Comments

H0 (null hypothesis): There was no statistically significant difference between monthly treatment with 150 mg oral IBN and monthly treatment with placebo in relative change from baseline of mean lumbar spine (L2-L4 BMD).

H1 (alternative hypothesis): There was a statistically significant difference between monthly treatment with 150 mg oral IBN and monthly treatment with placebo in relative change from baseline of mean lumbar spine (L2-L4 BMD).

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The primary analysis was an ANOVA (two way classification), including treatment group and time since menopause (as a binary variable; 0.5-3 years, >3 years) as independent factors.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 4.1226
Confidence Interval (2-Sided) 95%
2.9613 to 5.2838
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Absolute Change From Baseline in Mean Lumbar Spine BMD at Month 12
Hide Description 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.
Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Ibandronate (IBN) 150 mg Monthly
Hide Arm/Group Description:
Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
Overall Number of Participants Analyzed 70 68
Mean (Standard Deviation)
Unit of Measure: g/cm^2
-0.0039  (0.0319) 0.0322  (0.0315)
3.Secondary Outcome
Title Relative Change From Baseline in Mean Proximal Femur BMD at Month 12
Hide Description 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.
Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Ibandronate (IBN) 150 mg Monthly
Hide Arm/Group Description:
Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
Overall Number of Participants Analyzed 71 68
Mean (Standard Deviation)
Unit of Measure: Percentage
Total hip -0.9265  (1.8790) 1.4855  (2.1862)
Trochanter -0.9120  (3.0025) 2.8688  (3.0906)
Femoral Neck -0.7537  (3.7743) 1.0930  (2.6466)
4.Secondary Outcome
Title Absolute Change From Baseline in BMD of the Proximal Femur at Month 12
Hide Description 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.
Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Ibandronate (IBN) 150 mg Monthly
Hide Arm/Group Description:
Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
Overall Number of Participants Analyzed 71 68
Mean (Standard Deviation)
Unit of Measure: g/cm^2
Total hip -0.0083  (0.0163) 0.0133  (0.0194)
Trochanter -0.0061  (0.0185) 0.0182  (0.0199)
Femoral neck -0.0061  (0.0284) 0.0078  (0.0202)
5.Secondary Outcome
Title Relative Change From Baseline in Serum C-telopeptide Crosslinks of Type 1 Collagen (CTX)
Hide Description 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.
Time Frame Baseline and 3, 6 and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Ibandronate (IBN) 150 mg Monthly
Hide Arm/Group Description:
Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
Overall Number of Participants Analyzed 83 77
Median (95% Confidence Interval)
Unit of Measure: Percentage
Month 3, n = 81, 72
-4.2230
(-11.4068 to 2.2989)
-55.7688
(-61.9565 to -46.7669)
Month 6, n = 77, 72
-6.5934
(-14.3590 to 0.6658)
-61.6459
(-64.5652 to -52.3364)
Month 12, n = 75, 68
-6.7416
(-14.6388 to 5.9238)
-56.5432
(-61.8357 to -46.7836)
6.Secondary Outcome
Title Absolute Change From Baseline in sCTX
Hide Description 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.
Time Frame Baseline and 3, 6, 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Ibandronate (IBN) 150 mg Monthly
Hide Arm/Group Description:
Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
Overall Number of Participants Analyzed 83 77
Median (95% Confidence Interval)
Unit of Measure: ng/ml
Month 3, n = 81, 72
-0.0350
(-0.0620 to 0.0130)
-0.2570
(-0.2930 to -0.2060)
Month 6, n = 77, 72
-0.0350
(-0.0670 to 0.0050)
-0.2675
(-0.3090 to -0.2300)
Month 12, n = 75, 68
-0.0320
(-0.0890 to 0.0250)
-0.2560
(-0.3030 to -0.1850)
7.Secondary Outcome
Title Percentage of Responders
Hide Description 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.
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Ibandronate (IBN) 150 mg Monthly
Hide Arm/Group Description:
Participants with postmenopausal osteopenia who were administered matching placebo tablet PO once monthly. All participants received 500 mg/d calcium and 400 international units [IU]/d vitamin D as dietary supplements consisting of one tablet a day of OSCAL for the duration of the study. Participants received 12 months of treatment and were followed for an additional period of 15 days.
Participants with postmenopausal osteopenia who were administered 150 mg IBN tablet orally (PO) once monthly. All participants received 500 mg/d calcium and 400 international units [IU]/d vitamin D as dietary supplements consisting of one tablet a day of OSCAL for the duration of the study. Participants received 12 months of treatment and were followed for an additional period of 15 days.
Overall Number of Participants Analyzed 83 77
Measure Type: Number
Unit of Measure: Percentage
Lumbar spine equal to or above baseline 38.6 88.2
Proximal femur equal to or above baseline 15.5 60.3
LS and proximal femur equal to or above baseline 8.5 54.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ibandronate (IBN) 150 mg Monthly
Comments Lumbar BMD: Adjusted treatment effect - The treatment effect and 95% C.I. were represented by presenting OR. These were estimated by fitting a logistic regression model, with responder outcome (responder/non-responder) as the dependent variable and the treatment group (oral IBN 150 mg/Placebo) and time since menopause as the independent variables. An OR of >1 indicated participants treated with IBN were more likely to have BMD above or equal to baseline relative to those treated with placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 12.51
Confidence Interval (2-Sided) 95%
5.12 to 30.56
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ibandronate (IBN) 150 mg Monthly
Comments Proximal femur BMD: The adjusted treatment effect and 95% C.I. were represented by presenting OR. These were estimated by fitting a logistic regression model, with responder outcome (responder/non-responder) as the dependent variable and the treatment group (oral IBN 150 mg once monthly/Placebo) and time since menopause as the independent variables. An OR of >1 indicated participants treated with IBN were more likely to have BMD above or equal to baseline relative to those treated with placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 8.59
Confidence Interval (2-Sided) 95%
3.80 to 19.42
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Ibandronate (IBN) 150 mg Monthly
Comments Lumbar Spine and Proximal Femur BMD: The adjusted treatment effect and 95% C.I. were represented by presenting OR. These were estimated by fitting a logistic regression model, with responder outcome (responder/non-responder) as the dependent variable, and treatment group (oral IBN150 mg/Placebo) and time since menopause as the independent variables. An OR of >1 indicated participants treated with IBN were more likely to have BMD above or equal to baseline relative to those treated with placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 13.80
Confidence Interval (2-Sided) 95%
5.17 to 36.79
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame Up to 15 days after end of study treatment (Approximately 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included participants who had at least one dose of the trial medication documented in the CRF whether withdrawn prematurely or not.
Arm/Group Title Placebo Ibandronate (IBN) 150 mg Monthly
Hide Arm/Group Description:
Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
Overall Number of Participants Analyzed 83 77
Measure Type: Number
Unit of Measure: participants
Any AE 64 60
SAE 1 3
9.Secondary Outcome
Title Number of Participants With Marked Laboratory Abnormalities
Hide Description 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].
Time Frame Screening up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included participants who had at least one dose of the trial medication documented in the CRF whether withdrawn prematurely or not.
Arm/Group Title Placebo Ibandronate (IBN) 150 mg Monthly
Hide Arm/Group Description:
Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
Overall Number of Participants Analyzed 83 77
Measure Type: Number
Unit of Measure: participants
WBC, low 1 0
ALT, high 2 0
Phosphate, high 1 0
Time Frame Up to 15 days after end of study treatment (Approximately 2 years)
Adverse Event Reporting Description SAEs and non-serious AEs were reported for members of the safety population, comprised of participants who had at least one dose of the trial medication documented in the CRF whether withdrawn prematurely or not.
 
Arm/Group Title Placebo Ibandronate (IBN) 150 mg Monthly
Hide Arm/Group Description Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days. Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
All-Cause Mortality
Placebo Ibandronate (IBN) 150 mg Monthly
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Placebo Ibandronate (IBN) 150 mg Monthly
Affected / at Risk (%) Affected / at Risk (%)
Total   1/83 (1.20%)   3/77 (3.90%) 
General disorders     
Chest pain  1  0/83 (0.00%)  1/77 (1.30%) 
Infections and infestations     
Cellulitis  1  1/83 (1.20%)  0/77 (0.00%) 
Pyelonephritis  1  0/83 (0.00%)  1/77 (1.30%) 
Injury, poisoning and procedural complications     
Upper limb fracture  1  0/83 (0.00%)  1/77 (1.30%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Ibandronate (IBN) 150 mg Monthly
Affected / at Risk (%) Affected / at Risk (%)
Total   41/82 (50.00%)   40/76 (52.63%) 
Gastrointestinal disorders     
Dyspepsia  1  4/82 (4.88%)  4/76 (5.26%) 
Nausea  1  3/82 (3.66%)  5/76 (6.58%) 
Dental caries  1  3/82 (3.66%)  4/76 (5.26%) 
General disorders     
Influenza like illness  1  0/82 (0.00%)  4/76 (5.26%) 
Infections and infestations     
Upper respiratory tract infection  1  12/82 (14.63%)  6/76 (7.89%) 
Nasopharyngitis  1  4/82 (4.88%)  3/76 (3.95%) 
Urinary tract infection  1  6/82 (7.32%)  1/76 (1.32%) 
Metabolism and nutrition disorders     
Hypercholesterolaemia  1  1/82 (1.22%)  4/76 (5.26%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  8/82 (9.76%)  12/76 (15.79%) 
Pain in extremity  1  5/82 (6.10%)  5/76 (6.58%) 
Back pain  1  5/82 (6.10%)  2/76 (2.63%) 
Myalgia  1  2/82 (2.44%)  5/76 (6.58%) 
Nervous system disorders     
Headache  1  4/82 (4.88%)  4/76 (5.26%) 
Psychiatric disorders     
Depression  1  1/82 (1.22%)  4/76 (5.26%) 
Insomnia  1  1/82 (1.22%)  4/76 (5.26%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Roche Trial Information Hotline
Organization: F. Hoffmann-La Roche AG
Phone: +41 61 6878333
EMail: global.trial_information@roche.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00129623    
Other Study ID Numbers: BA18492
First Submitted: August 11, 2005
First Posted: August 12, 2005
Results First Submitted: December 5, 2015
Results First Posted: January 11, 2016
Last Update Posted: January 11, 2016