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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
This 2 arm study will investigate the efficacy and safety of Bonviva (150mg po monthly) in the prevention of glucocorticoid-induced osteoporosis in post-menopausal women. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, with vitamin D and calcium supplementation. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibandronate | Experimental | Participants received monthly oral ibandronate (150 milligrams [mg]) for 12 months. |
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| Placebo | Placebo Comparator | Participants received monthly oral placebo for 12 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | po monthly for 12 months |
| |
| ibandronate |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12 | Lumbar spine BMD was measured at Baseline, and Months 6 and 12 using dual-energy x-ray absorptiometry (DXA). Percent change from Baseline to Month 12 was calculated using analysis of covariance. | Baseline and Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Mean Lumbar Spine BMD at Month 6 | Lumbar spine BMD was measured at Baseline and Month 6 using DXA. Percent change from Baseline to Month 6 was calculated using analysis of covariance. | Baseline and Month 6 |
| Percent Change From Baseline in Mean Total Hip BMD at Month 6 and Month 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hämeenlinna | 13530 | Finland | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Ibandronate | Participants received 150 milligram (mg) ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 International Units (IU) Vitamin D per day. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
150mg po monthly for 12 months |
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Left total hip BMD was measured by DXA at Baseline, and Months 6 and 12. If there was prosthesis of left hip, the measurement of right total hip BMD was done by DXA. Percent change from Baseline to Months 6 and 12 was calculated using analysis of (co)variance for repeated measurements. |
| Baseline and Months 6 and 12 |
| Percent Change From Baseline in Bone Turnover Markers at Month 1, Month 6 and Month 12 | Serum C-terminal Telopeptide of Type 1 Collagen (sCTX), Serum Procollagen Type 1 N-terminal Propeptide (P1NP) and Serum Bone Tartrate-resistant Acid Phosphatase Isoform 5b (TRACP) are measures of bone resorption and are measured as nanograms per milliliter (ng/mL). Percent change from Baseline to Months 1, 6 and 12 was calculated using analysis of covariance for repeated measurements. | Baseline and Months 1, 6 and 12 |
| Percentage of Participants Withdrawn Due to Worsening in BMD at 6 Months and/or Worsening in BMD at Least 7 Percent (%) at Any Site at 6 Months | Worsening in BMD was defined as BMD T-score at any site less than or equal to (≤) - 2.5 standard deviations and/or worsening in BMD of at least 7% at any site. | Month 6 |
| Helsinki |
| 00100 |
| Finland |
| Helsinki | 00290 | Finland |
| Helsinki | 00350 | Finland |
| Hyvinkää | 05800 | Finland |
| Jyväskylä | 10100 | Finland |
| Jyväskylä | 40100 | Finland |
| Kuopio | 70211 | Finland |
| Lahti | 15110 | Finland |
| Oulu | 90029 | Finland |
| Oulu | 90100 | Finland |
| Tampere | 33100 | Finland |
| Tampere | 33101 | Finland |
| Turku | 20100 | Finland |
| Vantaa | 01300 | Finland |
Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
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| NOT COMPLETED |
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The intent-to-treat (ITT) population included all participants randomized and who had at least one follow up efficacy data time point available.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ibandronate | Participants received 150 mg ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day. |
| BG001 | Placebo | Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12 | Lumbar spine BMD was measured at Baseline, and Months 6 and 12 using dual-energy x-ray absorptiometry (DXA). Percent change from Baseline to Month 12 was calculated using analysis of covariance. | Intent-to-treat (ITT) population | Posted | Mean | Standard Deviation | percent change in BMD | Baseline and Month 12 |
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| Secondary | Percent Change From Baseline in Mean Lumbar Spine BMD at Month 6 | Lumbar spine BMD was measured at Baseline and Month 6 using DXA. Percent change from Baseline to Month 6 was calculated using analysis of covariance. | ITT Population | Posted | Mean | Standard Deviation | percent change in BMD | Baseline and Month 6 |
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| Secondary | Percent Change From Baseline in Mean Total Hip BMD at Month 6 and Month 12 | Left total hip BMD was measured by DXA at Baseline, and Months 6 and 12. If there was prosthesis of left hip, the measurement of right total hip BMD was done by DXA. Percent change from Baseline to Months 6 and 12 was calculated using analysis of (co)variance for repeated measurements. | ITT population; number (n) equals (=) number of participants analyzed at the specified visit. | Posted | Mean | Standard Deviation | percent change in BMD | Baseline and Months 6 and 12 |
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| Secondary | Percent Change From Baseline in Bone Turnover Markers at Month 1, Month 6 and Month 12 | Serum C-terminal Telopeptide of Type 1 Collagen (sCTX), Serum Procollagen Type 1 N-terminal Propeptide (P1NP) and Serum Bone Tartrate-resistant Acid Phosphatase Isoform 5b (TRACP) are measures of bone resorption and are measured as nanograms per milliliter (ng/mL). Percent change from Baseline to Months 1, 6 and 12 was calculated using analysis of covariance for repeated measurements. | ITT population; n=number of participants analyzed at the specified visit for the given parameter. | Posted | Mean | Standard Deviation | percent change in bone turnover markers | Baseline and Months 1, 6 and 12 |
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| Secondary | Percentage of Participants Withdrawn Due to Worsening in BMD at 6 Months and/or Worsening in BMD at Least 7 Percent (%) at Any Site at 6 Months | Worsening in BMD was defined as BMD T-score at any site less than or equal to (≤) - 2.5 standard deviations and/or worsening in BMD of at least 7% at any site. | ITT population | Posted | Number | percentage of participants | Month 6 |
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Adverse events were collected from the date of randomization until 15 days after the end of study at 12 months.
The safety population included all participants who had at least one dose of the trial medication, whether withdrawn prematurely or not, and at least one follow-up data point. Two participants received both treatments and were allocated to the ibandronate group for all assessments of safety.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ibandronate | Participants received 150 mg ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day. | 10 | 70 | 19 | 70 | ||
| EG001 | Placebo | Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day. | 6 | 70 | 26 | 70 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agranulocytosis | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
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| Anaemia due to gastrointestinal bleeding | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
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| Acute pancreatitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Erysipelas | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Acute pyelonephritis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Concussion | General disorders | MedDRA | Non-systematic Assessment |
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| Poisoning | Investigations | MedDRA | Non-systematic Assessment |
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| Radius fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Hip fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Follicle centre lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
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| Malignant tongue neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Deep vein thrombosis | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
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| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
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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 after the first publication or presentation that involves the overall study. Sponsor may request that confidential information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmannb-LaRoche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077557 | Ibandronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| Male |
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