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This study will evaluate whether an early positive response to once-monthly oral ibandronate in treatment-naive participants with postmenopausal osteoporosis is predictive of efficacy later in treatment. The anticipated time on study treatment is 6 months, and the target sample size is 360 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibandronate Group 1 | Experimental | Participants will receive a 6-month regimen with oral ibandronate, 150 mg once monthly. Group 1 will receive a physician consultation after 4 months of treatment to review bone turnover test results. |
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| Ibandronate Group 2 | Experimental | Participants will receive a 6-month regimen with oral ibandronate, 150 mg once monthly. Group 2 will not receive a physician consultation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibandronate | Drug | Participants will receive oral ibandronate, 150 mg once weekly, for approximately 6 months. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline to Month 6 in Serum C-terminal Telopeptide of Type 1 Collagen (CTX) | Serum CTX is a measure of bone resorption and is measured as nanograms per milliliter (ng/mL). Percent change from Baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group). | Baseline, Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline to Month 6 in Urine N-terminal Telopeptide of Type 1 Collagen (NTX) | Urine NTX is a measure of bone resorption and is measured as millimoles bone collagen equivalents per millimoles creatinine. Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montgomery | Alabama | 36111 | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Ibandronate (Consult Group) | Participants received ibandronate 150-milligram (mg) tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and received physician consultation on bone turnover marker (BTM) response. |
| FG001 | Ibandronate (Non-consult Group) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Baseline, Month 6 |
| Percent Change From Baseline to Month 6 in Serum Procollagen Type 1 N-terminal Propeptide (P1NP) | Serum P1NP is a measure of bone resorption and is measured as ng/mL. Percent change from baseline to Month 6 was calculated using Month 6 value minus Baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group). | Baseline, Month 6 |
| Percent Change From Baseline to Month 6 in Serum Osteocalcin | Serum osteocalcin is a measure of bone resorption and is measured as ng/mL. Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group). | Baseline, Month 6 |
| Percent Change From Baseline to Month 6 in Serum Bone-Specific Alkaline Phosphatase (BSAP) | Serum BSAP is a measure of bone resorption and is measured as ng/mL. Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group). | Baseline, Month 6 |
| Percentage of Participants Who Were "Very Confident" or "Confident" to Items on the Boniva Confidence Scale (BCS) at Month 6 | The BCS is designed to measure the participant's confidence level that Boniva (ibandronate) therapy is effective in treating osteoporosis and reducing the risk of fracture. Response options ranged on a 5-point scale from 'Not At All Confident' to 'Very Confident.' A Boniva confidence responder was defined as a participant who reported a response of 'confident' or 'very confident' on the 2 items in BCS. (1) ibandronate was effective in treating osteoporosis and (2) ibandronate reduces the risk of breaking a bone. | Month 6 |
| Chandler |
| Arizona |
| 85225 |
| United States |
| Peoria | Arizona | 85381 | United States |
| Hot Springs | Arkansas | 71913 | United States |
| Pine Bluff | Arkansas | 71603 | United States |
| Anaheim | California | 92801 | United States |
| Beverly Hills | California | 90211 | United States |
| Carmichael | California | 95608 | United States |
| Wilmington | Delaware | 19805 | United States |
| DeLand | Florida | 32720 | United States |
| Miami | Florida | 33176 | United States |
| Miami | Florida | 33186 | United States |
| Palm Habor | Florida | 34684 | United States |
| Palm Springs | Florida | 33461 | United States |
| West Palm Beach | Florida | 33409 | United States |
| Atlanta | Georgia | 30309 | United States |
| Rome | Georgia | 30165 | United States |
| Morton Grove | Illinois | 60053 | United States |
| Indianapolis | Indiana | 46202 | United States |
| Waterloo | Iowa | 50702 | United States |
| Baltimore | Maryland | 21209 | United States |
| Hagerstown | Maryland | 21740 | United States |
| Reistertown | Maryland | 21136 | United States |
| Olive Branch | Mississippi | 38654 | United States |
| Jefferson City | Missouri | 65109 | United States |
| St Louis | Missouri | 63108 | United States |
| Omaha | Nebraska | 68131 | United States |
| Bloomfield | New Jersey | 07003 | United States |
| New York | New York | 10016 | United States |
| The Bronx | New York | 10461 | United States |
| Morehead City | North Carolina | 28557 | United States |
| Morganton | North Carolina | 28655 | United States |
| Raleigh | North Carolina | 27612 | United States |
| Oklahoma City | Oklahoma | 73112 | United States |
| Medford | Oregon | 97504 | United States |
| Doylestown | Pennsylvania | 18901 | United States |
| Langhorne | Pennsylvania | 19047 | United States |
| Philadelphia | Pennsylvania | 19131 | United States |
| Mt. Pleasant | South Carolina | 29464 | United States |
| Spartanburg | South Carolina | 29307 | United States |
| Morristown | Tennessee | 37813 | United States |
| Murfreesboro | Tennessee | 37130 | United States |
| Nashville | Tennessee | 37203 | United States |
| Amarillo | Texas | 79106 | United States |
| Fort Worth | Texas | 76101 | United States |
| San Antonio | Texas | 78229 | United States |
| Texarkana | Texas | 75503 | United States |
| Richmond | Virginia | 23226 | United States |
| Tacoma | Washington | 98405 | United States |
| Madison | Wisconsin | 53705 | United States |
| Ponce | 00717-1318 | Puerto Rico |
| San Juan | 00927 | Puerto Rico |
| San Juan | 00935 | Puerto Rico |
Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and did not receive physician consultation on BTM response. |
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| NOT COMPLETED |
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Intent-to-Treat (ITT) Population: All enrolled participants who received at least 1 dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ibandronate (Consult Group) | Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and received physician consultation on BTM response. |
| BG001 | Ibandronate (Non-consult Group) | Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and did not receive physician consultation on BTM response. |
| 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 to Month 6 in Serum C-terminal Telopeptide of Type 1 Collagen (CTX) | Serum CTX is a measure of bone resorption and is measured as nanograms per milliliter (ng/mL). Percent change from Baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group). | ITT population observed cases: all participants of ITT population with available data for this outcome measure. | Posted | Mean | Standard Deviation | percent change | Baseline, Month 6 |
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| Secondary | Percent Change From Baseline to Month 6 in Urine N-terminal Telopeptide of Type 1 Collagen (NTX) | Urine NTX is a measure of bone resorption and is measured as millimoles bone collagen equivalents per millimoles creatinine. Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group). | ITT population observed cases: all participants of ITT population with available data for this outcome measure. | Posted | Mean | Standard Deviation | percent change | Baseline, Month 6 |
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| Secondary | Percent Change From Baseline to Month 6 in Serum Procollagen Type 1 N-terminal Propeptide (P1NP) | Serum P1NP is a measure of bone resorption and is measured as ng/mL. Percent change from baseline to Month 6 was calculated using Month 6 value minus Baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group). | ITT population observed cases: all participants of ITT population with available data for this outcome measure. | Posted | Mean | Standard Deviation | percent change | Baseline, Month 6 |
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| Secondary | Percent Change From Baseline to Month 6 in Serum Osteocalcin | Serum osteocalcin is a measure of bone resorption and is measured as ng/mL. Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group). | ITT population observed cases: all participants of ITT population with available data for this outcome measure. | Posted | Mean | Standard Deviation | percent change | Baseline, Month 6 |
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| Secondary | Percent Change From Baseline to Month 6 in Serum Bone-Specific Alkaline Phosphatase (BSAP) | Serum BSAP is a measure of bone resorption and is measured as ng/mL. Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group). | ITT population observed cases: all participants of ITT population with available data for this outcome measure. | Posted | Mean | Standard Deviation | percent change | Baseline, Month 6 |
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| Secondary | Percentage of Participants Who Were "Very Confident" or "Confident" to Items on the Boniva Confidence Scale (BCS) at Month 6 | The BCS is designed to measure the participant's confidence level that Boniva (ibandronate) therapy is effective in treating osteoporosis and reducing the risk of fracture. Response options ranged on a 5-point scale from 'Not At All Confident' to 'Very Confident.' A Boniva confidence responder was defined as a participant who reported a response of 'confident' or 'very confident' on the 2 items in BCS. (1) ibandronate was effective in treating osteoporosis and (2) ibandronate reduces the risk of breaking a bone. | ITT population | Posted | Number | percentage of participants | Month 6 |
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AEs were recorded from baseline through Month 6 and in the follow-up period (15 days after the final Month 6 visit).
Safety population: All participants who received at least 1 dose of study medication and had at least 1 post-baseline safety measurement. Safety data was reported for all participants combined (Consult group plus Non-consult group).
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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 (All Participants) | Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months. Depending on the physician consultation on BTM response, participants were randomized into consult group and non-consult group. | 17 | 308 | 76 | 308 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Ventricular arrhythmia | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Melena | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Accidental overdose | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
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| Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
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| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | 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 only after the first publication or presentation that involves the Overall Study. The sponsor may request that the confidential information be deleted and/or the publication to be postponed inorder to present the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 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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