A Study of Bonviva (Ibandronate) and Alendronate on Renal Function in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease.
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00503113
First received: July 17, 2007
Last updated: May 17, 2011
Last verified: May 2011
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Results First Received: March 31, 2011
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Condition: |
Post-Menopausal Osteoporosis |
| Interventions: |
Drug: ibandronate [Bonviva/Boniva] Drug: Alendronate |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| Total 801 participants randomized. Of the randomized patients, 263 who received at least one dose of ibandronate as an injection, 263 who received at least one dose of ibandronate as an infusion and 267 patients who received at least one dose of alendronate had at least one post-baseline assessment and were included in the safety analysis. |
Reporting Groups
| Description | |
|---|---|
| Ibandronate 3 mg Injection | Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months. |
| Ibandronate 3 mg Infusion | Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months. |
| Alendronate 70 mg Oral | Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg). |
Participant Flow: Overall Study
| Ibandronate 3 mg Injection | Ibandronate 3 mg Infusion | Alendronate 70 mg Oral | |
|---|---|---|---|
| STARTED | 268 | 264 | 269 |
| Intent to Treat Population (ITT) | 262 | 261 | 268 |
| Per Protocol Population (PP) | 246 | 243 | 241 |
| Safety Population | 263 | 263 | 267 |
| COMPLETED | 235 | 236 | 241 |
| NOT COMPLETED | 33 | 28 | 28 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Ibandronate 3 mg Injection | Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months. |
| Ibandronate 3 mg Infusion | Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months. |
| Alendronate 70 mg Oral | Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg). |
| Total | Total of all reporting groups |
Baseline Measures
| Ibandronate 3 mg Injection | Ibandronate 3 mg Infusion | Alendronate 70 mg Oral | Total | |
|---|---|---|---|---|
|
Number of Participants
[units: participants] |
263 | 263 | 267 | 793 |
|
Age
[units: years] Mean ± Standard Deviation |
71.7 ± 6.77 | 71.5 ± 5.89 | 71.7 ± 6.3 | 71.6 ± 6.32 |
|
Gender
[units: participants] |
||||
| Female | 263 | 263 | 267 | 793 |
| Male | 0 | 0 | 0 | 0 |
Outcome Measures
| 1. Primary: | Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula) [ Time Frame: Baseline and 9 months ] |
| 2. Secondary: | Absolute Change From Baseline in Actual GFR (Using Cockcroft-Gault [CG] Formula) [ Time Frame: Baseline and 9 months ] |
| 3. Secondary: | Relative Change From Baseline in Actual GFR (Using Abbreviated MDRD Formula) [ Time Frame: Baseline and 9 months ] |
| 4. Secondary: | Relative Change From Baseline in Actual GFR (Using CG Formula) [ Time Frame: Baseline and 9 months ] |
| 5. Secondary: | Absolute Change From Baseline in Mean Serum Creatinine. [ Time Frame: Baseline and 9 months ] |
| 6. Secondary: | Relative Change From Baseline in Mean Serum Creatinine. [ Time Frame: Baseline and 9 months ] |
| 7. Secondary: | Absolute Change From Baseline in Urine Albumin-to-Creatinine Ratio. [ Time Frame: Baseline and 9 months ] |
| 8. Secondary: | Relative Change From Baseline in Urine Albumin-to-Creatinine Ratio. [ Time Frame: Baseline and 9 months ] |
Serious Adverse Events| Time Frame | AEs are considered to have occurred ‘On treatment’, defined as first dose and up 106 days after last dose if patient’s actual treatment is ibandronate, or up to 22 days after last dose if patient’s actual treatment is the alendronate. |
|---|---|
| Additional Description | No text entered. |
Reporting Groups
| Description | |
|---|---|
| Ibandronate 3 mg Injection | Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months. |
| Ibandronate 3 mg Infusion | Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months. |
| Alendronate 70 mg Oral | Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg). |
Serious Adverse Events
| Ibandronate 3 mg Injection | Ibandronate 3 mg Infusion | Alendronate 70 mg Oral | |
|---|---|---|---|
| Total, serious adverse events | |||
| # participants affected / at risk | 19/263 (7.22%) | 15/263 (5.70%) | 13/267 (4.87%) |
| Blood and lymphatic system disorders | |||
| Autoimmune Thrombocytopenia * 1 | |||
| # participants affected / at risk | 0/263 (0.00%) | 1/263 (0.38%) | 0/267 (0.00%) |
| Cardiac disorders | |||
| Atrial Fibrillation * 1 | |||
| # participants affected / at risk | 1/263 (0.38%) | 1/263 (0.38%) | 0/267 (0.00%) |
| Cardiac Failure Congestive * 1 | |||
| # participants affected / at risk | 2/263 (0.76%) | 0/263 (0.00%) | 0/267 (0.00%) |
| Acute Coronary Syndrome * 1 | |||
| # participants affected / at risk | 0/263 (0.00%) | 1/263 (0.38%) | 0/267 (0.00%) |
| Angina Pectoris * 1 | |||
| # participants affected / at risk | 0/263 (0.00%) | 1/263 (0.38%) | 0/267 (0.00%) |
| Conduction Disorder * 1 | |||
| # participants affected / at risk | 0/263 (0.00%) | 1/263 (0.38%) | 0/267 (0.00%) |
| Myocardial Infarction * 1 | |||
| # participants affected / at risk | 1/263 (0.38%) | 0/263 (0.00%) | 0/267 (0.00%) |
| Supraventricular Tachycardia * 1 | |||
| # participants affected / at risk | 0/263 (0.00%) | 0/263 (0.00%) | 1/267 (0.37%) |
| Gastrointestinal disorders | |||
| Abdominal Pain * 1 | |||
| # participants affected / at risk | 1/263 (0.38%) | 1/263 (0.38%) | 0/267 (0.00%) |
| Haematochezia * 1 | |||
| # participants affected / at risk | 1/263 (0.38%) | 0/263 (0.00%) | 0/267 (0.00%) |
| Nausea * 1 | |||
| # participants affected / at risk | 0/263 (0.00%) | 1/263 (0.38%) | 0/267 (0.00%) |
| Pancreatitis Acute * 1 | |||
| # participants affected / at risk | 1/263 (0.38%) | 0/263 (0.00%) | 0/267 (0.00%) |
| Peptic Ulcer Perforation * 1 | |||
| # participants affected / at risk | 0/263 (0.00%) | 1/263 (0.38%) | 0/267 (0.00%) |
| Small Intestinal Obstruction * 1 | |||
| # participants affected / at risk | 1/263 (0.38%) | 0/263 (0.00%) | 0/267 (0.00%) |
| Vomiting * 1 | |||
| # participants affected / at risk | 0/263 (0.00%) | 1/263 (0.38%) | 0/267 (0.00%) |
| Hepatobiliary disorders | |||
| Cholecystitis * 1 | |||
| # participants affected / at risk | 0/263 (0.00%) | 1/263 (0.38%) | 1/267 (0.37%) |
| Cholecystitis Acute * 1 | |||
| # participants affected / at risk | 0/263 (0.00%) | 0/263 (0.00%) | 1/267 (0.37%) |
| Cholelithiasis * 1 | |||
| # participants affected / at risk | 0/263 (0.00%) | 0/263 (0.00%) | 1/267 (0.37%) |
| Infections and infestations | |||
| Pneumonia * 1 | |||
| # participants affected / at risk | 1/263 (0.38%) | 1/263 (0.38%) | 1/267 (0.37%) |
| Abdominal Abscess * 1 | |||
| # participants affected / at risk | 0/263 (0.00%) | 0/263 (0.00%) | 1/267 (0.37%) |
| Gastroenteritis * 1 | |||
| # participants affected / at risk | 0/263 (0.00%) | 0/263 (0.00%) | 1/267 (0.37%) |
| Herpes Zoster * 1 | |||
| # participants affected / at risk | 0/263 (0.00%) | 1/263 (0.38%) | 0/267 (0.00%) |
| Pyelonephritis * 1 | |||
| # participants affected / at risk | 0/263 (0.00%) | 0/263 (0.00%) | 1/267 (0.37%) |
| Urinary Tract Infection * 1 | |||
| # participants affected / at risk | 0/263 (0.00%) | 1/263 (0.38%) | 0/267 (0.00%) |
| Injury, poisoning and procedural complications | |||
| Femur Fracture * 1 | |||
| # participants affected / at risk | 3/263 (1.14%) | 1/263 (0.38%) | 4/267 (1.50%) |
| Femoral Neck Fracture * 1 | |||
| # participants affected / at risk | 3/263 (1.14%) | 1/263 (0.38%) | 1/267 (0.37%) |
| Ankle Fracture * 1 | |||
| # participants affected / at risk | 0/263 (0.00%) | 0/263 (0.00%) | 1/267 (0.37%) |
| Fall * 1 | |||
| # participants affected / at risk | 0/263 (0.00%) | 1/263 (0.38%) | 0/267 (0.00%) |
| Head Injury * 1 | |||
| # participants affected / at risk | 0/263 (0.00%) | 1/263 (0.38%) | 0/267 (0.00%) |
| Multiple Drug Overdose Accidental * 1 | |||
| # participants affected / at risk | 0/263 (0.00%) | 0/263 (0.00%) | 1/267 (0.37%) |
| Multiple Fractures * 1 | |||
| # participants affected / at risk | 0/263 (0.00%) | 1/263 (0.38%) | 0/267 (0.00%) |
| Traumatic Brain Injury * 1 | |||
| # participants affected / at risk | 0/263 (0.00%) | 1/263 (0.38%) | 0/267 (0.00%) |
| Vascular Pseudoaneurysm * 1 | |||
| # participants affected / at risk | 0/263 (0.00%) | 1/263 (0.38%) | 0/267 (0.00%) |
| Metabolism and nutrition disorders | |||
| Electrolyte Imbalance * 1 | |||
| # participants affected / at risk | 0/263 (0.00%) | 0/263 (0.00%) | 1/267 (0.37%) |
| Hyponatraemia * 1 | |||
| # participants affected / at risk | 0/263 (0.00%) | 0/263 (0.00%) | 1/267 (0.37%) |
| Musculoskeletal and connective tissue disorders | |||
| Osteoarthritis * 1 | |||
| # participants affected / at risk | 2/263 (0.76%) | 0/263 (0.00%) | 2/267 (0.75%) |
| Back Pain * 1 | |||
| # participants affected / at risk | 1/263 (0.38%) | 0/263 (0.00%) | 0/267 (0.00%) |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | |||
| Breast Cancer * 1 | |||
| # participants affected / at risk | 2/263 (0.76%) | 0/263 (0.00%) | 0/267 (0.00%) |
| Breast Cancer Stage II * 1 | |||
| # participants affected / at risk | 0/263 (0.00%) | 0/263 (0.00%) | 1/267 (0.37%) |
| Colon Cancer * 1 | |||
| # participants affected / at risk | 0/263 (0.00%) | 0/263 (0.00%) | 1/267 (0.37%) |
| Lymphoma * 1 | |||
| # participants affected / at risk | 0/263 (0.00%) | 1/263 (0.38%) | 0/267 (0.00%) |
| Nervous system disorders | |||
| Dizziness * 1 | |||
| # participants affected / at risk | 1/263 (0.38%) | 0/263 (0.00%) | 0/267 (0.00%) |
| Hemiparesis * 1 | |||
| # participants affected / at risk | 1/263 (0.38%) | 0/263 (0.00%) | 0/267 (0.00%) |
| Ischemic Stroke * 1 | |||
| # participants affected / at risk | 1/263 (0.38%) | 0/263 (0.00%) | 0/267 (0.00%) |
| Ruptured Cerebral Aneurysm * 1 | |||
| # participants affected / at risk | 0/263 (0.00%) | 0/263 (0.00%) | 1/267 (0.37%) |
| Senile Dementia * 1 | |||
| # participants affected / at risk | 0/263 (0.00%) | 1/263 (0.38%) | 0/267 (0.00%) |
| Subarachnoid Haemorrhage * 1 | |||
| # participants affected / at risk | 1/263 (0.38%) | 0/263 (0.00%) | 0/267 (0.00%) |
| Reproductive system and breast disorders | |||
| Breast Mass * 1 | |||
| # participants affected / at risk | 0/263 (0.00%) | 1/263 (0.38%) | 0/267 (0.00%) |
| Respiratory, thoracic and mediastinal disorders | |||
| Chronic Obstructive Pulmonary Disease * 1 | |||
| # participants affected / at risk | 0/263 (0.00%) | 1/263 (0.38%) | 1/267 (0.37%) |
| Asthma * 1 | |||
| # participants affected / at risk | 0/263 (0.00%) | 0/263 (0.00%) | 1/267 (0.37%) |
| Haemoptysis * 1 | |||
| # participants affected / at risk | 1/263 (0.38%) | 0/263 (0.00%) | 0/267 (0.00%) |
| Pulmonary Embolism * 1 | |||
| # participants affected / at risk | 1/263 (0.38%) | 0/263 (0.00%) | 0/267 (0.00%) |
| Vascular disorders | |||
| Hypertensive Crisis * 1 | |||
| # participants affected / at risk | 0/263 (0.00%) | 1/263 (0.38%) | 0/267 (0.00%) |
| Temporal Arteritis * 1 | |||
| # participants affected / at risk | 0/263 (0.00%) | 1/263 (0.38%) | 0/267 (0.00%) |
| * | Events were collected by non-systematic assessment |
|---|---|
| 1 | Term from vocabulary, MedDRA (12.0) |
Other Adverse Events
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| Principal Investigators are NOT employed by the organization sponsoring the study. |
| There is NOT 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. |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
Results Point of Contact:
Name/Title: Medical Communications
Organization: Hoffman-LaRoche
phone: 800-821-8590
Organization: Hoffman-LaRoche
phone: 800-821-8590
No publications provided
| Responsible Party: | Disclosures Group, Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00503113 History of Changes |
| Other Study ID Numbers: | BA20341 |
| Study First Received: | July 17, 2007 |
| Results First Received: | March 31, 2011 |
| Last Updated: | May 17, 2011 |
| Health Authority: | United States: Food and Drug Administration |