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| Study Type: | Interventional |
|---|---|
| Study Design: | Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment |
| Condition: |
Osteoporosis |
| Interventions: |
Drug: Teriparatide Drug: Alendronate Sodium Drug: Placebo |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| No text entered. |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No text entered. |
| Description | |
|---|---|
| Teriparatide | Teriparatide 20 micrograms/day injection plus oral placebo, 36 months |
| Alendronate | Alendronate 10 mg/day oral plus injection placebo, 36 months |
| Teriparatide | Alendronate | |
|---|---|---|
| STARTED | 214 | 214 |
| COMPLETED | 123 | 118 |
| NOT COMPLETED | 91 | 96 |
| Adverse Event | 30 | 18 |
| Withdrawal by Subject | 29 | 42 |
| Death | 9 | 15 |
| Lost to Follow-up | 4 | 13 |
| Protocol Violation | 3 | 4 |
| Protocol Entry Criteria Unmet | 1 | 2 |
| Sponsor Decision | 6 | 1 |
| Unspecified | 2 | 1 |
| Significant Lab Value | 2 | 0 |
| Physician Decision | 5 | 0 |
Baseline Characteristics
| Description | |
|---|---|
| Teriparatide | Teriparatide 20 micrograms/day injection plus oral placebo, 36 months |
| Alendronate | Alendronate 10 mg/day oral plus injection placebo, 36 months |
| Teriparatide | Alendronate | Total | |
|---|---|---|---|
|
Number of Participants [units: participants] |
214 | 214 | 428 |
|
Age, Customized [units: participants] |
|||
| Age < 35 years | 13 | 19 | 32 |
| 35 <= Age < 50 years | 55 | 35 | 90 |
| 50 <= Age < 65 years | 86 | 93 | 179 |
| Age >= 65 years | 60 | 67 | 127 |
|
Gender [units: participants] |
|||
| Female | 172 | 173 | 345 |
| Male | 42 | 41 | 83 |
|
Region of Enrollment [units: participants] |
|||
| United States | 62 | 64 | 126 |
| Belgium | 8 | 8 | 16 |
| Denmark | 4 | 3 | 7 |
| Austria | 1 | 2 | 3 |
| Norway | 1 | 1 | 2 |
| Argentina | 23 | 20 | 43 |
| Brazil | 72 | 73 | 145 |
| Colombia | 10 | 9 | 19 |
| Venezuela | 4 | 3 | 7 |
| Mexico | 14 | 15 | 29 |
| Finland | 1 | 2 | 3 |
| Germany | 14 | 14 | 28 |
|
Origin [units: participants] |
|||
| Caucasian | 153 | 148 | 301 |
| Non-Caucasian | 61 | 66 | 127 |
|
Prior Bisphosphonate User [units: participants] |
|||
| Yes | 20 | 20 | 40 |
| No | 194 | 194 | 388 |
|
Baseline Biochemical Markers of Bone Metabolism [units: ug/L] Mean ± Standard Deviation |
|||
| Serum N-terminal propeptide of type 1 procollagen | 46.161 ± 35.471 | 47.235 ± 29.606 | 46.704 ± 32.562 |
| Procollagen I carboxy-terminal propeptide | 166.402 ± 99.625 | 152.109 ± 56.637 | 158.845 ± 79.910 |
| Bone-specific alkaline phosphatase | 9.465 ± 4.522 | 9.711 ± 4.527 | 9.595 ± 4.513 |
| Osteocalcin | 17.130 ± 14.422 | 15.878 ± 10.286 | 16.492 ± 12.468 |
|
Baseline Bone Mineral Density [units: grams per square centimeters] Mean ± Standard Deviation |
|||
| Lumbar Spine Bone Mineral Density | 0.845 ± 0.131 | 0.844 ± 0.128 | 0.845 ± 0.129 |
| Total Hip Bone Mineral Density | 0.744 ± 0.113 | 0.757 ± 0.124 | 0.750 ± 0.119 |
| Femoral Neck Bone Mineral Density | 0.682 ± 0.114 | 0.697 ± 0.119 | 0.689 ± 0.116 |
|
C-terminal telopeptide of type I collagen [units: pmol/L] Mean ± Standard Deviation |
3790.483 ± 2478.189 | 4543.156 ± 4838.919 | 4185.328 ± 3907.204 |
Outcome Measures
| 1. Primary: | Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD) [ 18 month endpoint ] |
| 2. Secondary: | Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD), Female Subset [ 18 month endpoint ] |
| 3. Secondary: | Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined [ 3, 6, 12, 18, 24, 36 months ] |
| 4. Secondary: | Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset [ 3, 6, 12, and 18 months ] |
| 5. Secondary: | Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined [ 24 and 36 months and Endpoint at 36 months ] |
| 6. Secondary: | Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined [ 18, 24, 36 months, and 18 and 36 month endpoints ] |
| 7. Secondary: | Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined [ 18, 24, 36 months, and 18 and 36 month endpoints ] |
| 8. Secondary: | Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined [ 12, 18, 24, and 36 months ] |
| 9. Secondary: | Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined [ 12, 18, 24, and 36 months ] |
| 10. Secondary: | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum N-terminal Propeptide of Type 1 Procollagen [ 1, 6, 18, and 36 months ] |
| 11. Secondary: | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum C-terminal Propeptide of Type 1 Procollagen [ 1, 6, 18, and 36 months ] |
| 12. Secondary: | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Bone-Specific Alkaline Phosphatase [ 1, 6, 18, and 36 months ] |
| 13. Secondary: | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum Type 1 Collagen Degradation Fragments [ 1, 6, 18, and 36 months ] |
| 14. Secondary: | Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin [ 1, 6, 18, and 36 months ] |
| 15. Secondary: | Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures [ 36 months ] |
Serious Adverse Events| Time Frame | No text entered. |
|---|---|
| Additional Description | No text entered. |
| Description | |
|---|---|
| Teriparatide | Teriparatide 20 micrograms/day injection plus oral placebo, 36 months |
| Alendronate | Alendronate 10 mg/day oral plus injection placebo, 36 months |
| Teriparatide | Alendronate | |
|---|---|---|
| Total, serious adverse events | ||
| # participants affected | 70 | 64 |
| Blood and lymphatic system disorders | ||
| Anaemia † A # participants affected / at risk # events |
2/214 (0.93%) 2 |
1/214 (0.47%) 1 |
| Haemolytic anaemia † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Thrombocytopenia † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Cardiac disorders | ||
| Acute myocardial infarction † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Angina pectoris † A # participants affected / at risk # events |
1/214 (0.47%) 3 |
1/214 (0.47%) 1 |
| Atrial fibrillation † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Cardiac arrest † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Cardiac failure † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Cardiac failure congestive † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
2/214 (0.93%) 2 |
| Cardio-respiratory arrest † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Coronary artery disease † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Myocardial infarction † A # participants affected / at risk # events |
2/214 (0.93%) 2 |
2/214 (0.93%) 2 |
| Ventricular fibrillation † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Congenital, familial and genetic disorders | ||
| Epidermolysis † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Endocrine disorders | ||
| Adrenal insufficiency † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Inappropriate antidiuretic hormone secretion † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Eye disorders | ||
| Blindness † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Gastrointestinal disorders | ||
| Abdominal discomfort † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Abdominal pain † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Abdominal pain lower † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Abdominal pain upper † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 2 |
| Colitis ulcerative † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Constipation † A # participants affected / at risk # events |
2/214 (0.93%) 2 |
0/214 (0.00%) 0 |
| Diarrhoea † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Enterovesical fistula † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Gastric ulcer † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Gastritis † A # participants affected / at risk # events |
2/214 (0.93%) 2 |
0/214 (0.00%) 0 |
| Gastrointestinal haemorrhage † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
1/214 (0.47%) 1 |
| Hiatus hernia † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Lower gastrointestinal haemorrhage † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Reflux oesophagitis † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Small intestinal obstruction † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Subileus † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Vomiting † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| General disorders | ||
| Asthenia † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Chest pain † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Death † A # participants affected / at risk # events |
2/214 (0.93%) 2 |
4/214 (1.87%) 4 |
| Impaired healing † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Multi-organ failure † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Pain † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Ulcer † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Hepatobiliary disorders | ||
| Cholecystitis † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Cholelithiasis † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
1/214 (0.47%) 1 |
| Immune system disorders | ||
| Antiphospholipid syndrome † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Sarcoidosis † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Infections and infestations | ||
| Abscess † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Abscess bacterial † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Arthritis bacterial † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
1/214 (0.47%) 1 |
| Bronchitis † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Bronchopneumonia † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
2/214 (0.93%) 6 |
| Cardiac infection † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Cellulitis † A # participants affected / at risk # events |
3/214 (1.40%) 3 |
3/214 (1.40%) 3 |
| Chronic sinusitis † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Corneal infection † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Escherichia infection † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Gastroenteritis † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
2/214 (0.93%) 2 |
| Gastroenteritis salmonella † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Gastrointestinal infection † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Herpes zoster † A # participants affected / at risk # events |
2/214 (0.93%) 2 |
0/214 (0.00%) 0 |
| Intervertebral discitis † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Labyrinthitis † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Lobar pneumonia † A # participants affected / at risk # events |
2/214 (0.93%) 2 |
1/214 (0.47%) 1 |
| Lung abscess † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Lung infection † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Osteomyelitis † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Pneumonia † A # participants affected / at risk # events |
8/214 (3.74%) 8 |
6/214 (2.80%) 6 |
| Pneumonia staphylococcal † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Pneumonia streptococcal † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Pulmonary tuberculosis † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Respiratory tract infection † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Salmonella sepsis † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Sepsis † A # participants affected / at risk # events |
2/214 (0.93%) 2 |
2/214 (0.93%) 2 |
| Septic shock † A # participants affected / at risk # events |
2/214 (0.93%) 2 |
2/214 (0.93%) 2 |
| Sinusitis † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Tracheobronchitis † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Urinary tract infection † A # participants affected / at risk # events |
2/214 (0.93%) 2 |
4/214 (1.87%) 5 |
| Urosepsis † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Viral upper respiratory tract infection † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Injury, poisoning and procedural complications | ||
| Ankle fracture † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Device failure † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Fall † A # participants affected / at risk # events |
3/214 (1.40%) 3 |
3/214 (1.40%) 3 |
| Forearm fracture † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Hip fracture † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Lumbar vertebral fracture † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Multiple fractures † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Postoperative wound complication † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Radius fracture † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
1/214 (0.47%) 1 |
| Renal injury † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Road traffic accident † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Suture rupture † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Tendon rupture † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Tibia fracture † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Ulna fracture † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Metabolism and nutrition disorders | ||
| Dehydration † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Hypocalcaemia † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Hypoglycaemia † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Hypokalaemia † A # participants affected / at risk # events |
1/214 (0.47%) 2 |
0/214 (0.00%) 0 |
| Hyponatraemia † A # participants affected / at risk # events |
2/214 (0.93%) 3 |
0/214 (0.00%) 0 |
| Obesity † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Musculoskeletal and connective tissue disorders | ||
| Arthralgia † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
1/214 (0.47%) 1 |
| Back pain † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Costochondritis † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Intervertebral disc protrusion † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Musculoskeletal chest pain † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Osteoarthritis † A # participants affected / at risk # events |
3/214 (1.40%) 3 |
2/214 (0.93%) 2 |
| Osteonecrosis † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Pain in extremity † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Rheumatoid arthritis † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Spinal osteoarthritis † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Benign ovarian tumour † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Breast cancer † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Lung adenocarcinoma stage IV † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Multiple myeloma † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Non-Hodgkin's lymphoma † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Papillary thyroid cancer † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Prostate cancer † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Renal cell carcinoma stage unspecified † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Renal neoplasm † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Uterine leiomyoma † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Nervous system disorders | ||
| Cerebrovascular accident † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Cervical myelopathy † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Headache † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Intraventricular haemorrhage † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Paraesthesia † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Sensory disturbance † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Syncope † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
1/214 (0.47%) 1 |
| Transient ischaemic attack † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Psychiatric disorders | ||
| Agitation † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Confusional state † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Delusion † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Depression † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Renal and urinary disorders | ||
| Haematuria † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Hydronephrosis † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Nephrolithiasis † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Renal failure acute † A # participants affected / at risk # events |
2/214 (0.93%) 2 |
1/214 (0.47%) 1 |
| Renal failure chronic † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Ureteric obstruction † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Reproductive system and breast disorders | ||
| Prostatic intraepithelial neoplasia † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Vaginal haemorrhage † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Respiratory, thoracic and mediastinal disorders | ||
| Asthma † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Chronic obstructive pulmonary disease † A # participants affected / at risk # events |
5/214 (2.34%) 9 |
2/214 (0.93%) 2 |
| Dyspnoea † A # participants affected / at risk # events |
4/214 (1.87%) 4 |
2/214 (0.93%) 2 |
| Emphysema † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Hypoxia † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 3 |
| Interstitial lung disease † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Lung disorder † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Pneumonia aspiration † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Pneumothorax † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Pulmonary embolism † A # participants affected / at risk # events |
3/214 (1.40%) 3 |
2/214 (0.93%) 2 |
| Pulmonary fibrosis † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
1/214 (0.47%) 1 |
| Respiratory arrest † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
2/214 (0.93%) 2 |
| Respiratory failure † A # participants affected / at risk # events |
2/214 (0.93%) 2 |
2/214 (0.93%) 2 |
| Skin and subcutaneous tissue disorders | ||
| Panniculitis † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Skin ulcer † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Surgical and medical procedures | ||
| Arthrodesis † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Coronary artery bypass † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Hip arthroplasty † A # participants affected / at risk # events |
3/214 (1.40%) 3 |
0/214 (0.00%) 0 |
| Knee arthroplasty † A # participants affected / at risk # events |
3/214 (1.40%) 4 |
1/214 (0.47%) 2 |
| Surgery † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Thyroidectomy † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Vertebroplasty † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
2/214 (0.93%) 2 |
| Vascular disorders | ||
| Arterial insufficiency † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Arterial occlusive disease † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Deep vein thrombosis † A # participants affected / at risk # events |
2/214 (0.93%) 2 |
1/214 (0.47%) 1 |
| Haematoma † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Hypertension † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Peripheral vascular disorder † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| Shock † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Thrombophlebitis † A # participants affected / at risk # events |
0/214 (0.00%) 0 |
1/214 (0.47%) 1 |
| Venous thrombosis † A # participants affected / at risk # events |
1/214 (0.47%) 1 |
0/214 (0.00%) 0 |
| † | Indicates events were collected by systematic assessment. |
|---|---|
| A | Term from vocabulary, MedDRA 10.0 |
Other Adverse Events
More Information
| 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 agreement is:
|
| 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. |
| Responsible Party: | Eli Lilly ( Chief Medical Officer ) |
| Study ID Numbers: | 6484, B3D-US-GHBZ |
| Study First Received: | January 13, 2003 |
| Results First Received: | January 14, 2009 |
| Last Updated: | February 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00051558 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
