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| ID | Type | Description | Link |
|---|---|---|---|
| B3D-MC-GHDG |
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The purpose of this study is to compare the effect of injectable teriparatide to intranasal salmon calcitonin on lumbar spine bone mineral density, in the treatment of Chinese patients with established osteoporosis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teriparatide | Drug | Subcutaneous, 20 micrograms/day, 24 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Postmenopausal Women | Lumbar spine bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline. | Baseline to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Postmenopausal Women | Total hip bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline. | Baseline to 24 weeks |
| Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Postmenopausal Women |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Beijing | 100050 |
364 participants were randomized, but 2 females did not receive study drug and are not included in any of the analyses.
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| ID | Title | Description |
|---|---|---|
| FG000 | Teriparatide - Females | Subcutaneous, 20 micrograms/day, 24 weeks |
| FG001 | Calcitonin - Females | Intranasal, 200 International Units (IU)/day, 24 weeks |
| FG002 | Teriparatide - Males | Subcutaneous, 20 micrograms/day, 24 weeks |
| FG003 | Calcitonin - Males | Intranasal, 200 IU/day, 24 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Teriparatide - Females | Subcutaneous, 20 micrograms/day, 24 weeks |
| BG001 | Calcitonin - Females | Intranasal, 200 International Units (IU)/day, 24 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Postmenopausal Women | Lumbar spine bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline. | Number of Intention to Treat patients with baseline and at least one post baseline measurement. Last Observation Carried Forward. | Posted | Least Squares Mean | Standard Error | percentage change in lumbar spine BMD | Baseline to 24 weeks |
|
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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 | Teriparatide - Females | Subcutaneous, 20 micrograms/day, 24 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D019379 | Teriparatide |
| C028815 | salmon calcitonin |
| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Salmon Calcitonin | Drug | Intranasal, 200 International Units (IU)/day, 24 weeks |
|
Measures of serum osteocalcin (nanograms per milliliter). Change = Endpoint minus baseline. |
| Baseline to 12 weeks and 24 weeks |
| Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Men | Lumbar spine bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline. | Baseline to 24 weeks |
| Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Men | Total hip bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline. | Baseline to 24 weeks |
| Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Men | Measures of serum osteocalcin (nanograms per milliliter). Change = Endpoint minus baseline. | Baseline to 12 weeks and 24 weeks |
| China |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Chengdu | 610041 | China |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Nanjing | 210029 | China |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Shanghai | 200023 | China |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Wenzhou | 325027 | China |
| Adverse Event |
|
| Protocol Violation |
|
| Lost to Follow-up |
|
| Sponsor Decision |
|
| Death |
|
| BG002 | Teriparatide - Males | Subcutaneous, 20 micrograms/day, 24 weeks |
| BG003 | Calcitonin - Males | Intranasal, 200 IU/day, 24 weeks |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Race/Ethnicity | Number | participants |
|
| Duration of Osteoporosis | Mean | Standard Deviation | years |
|
|
|
|
| Secondary | Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Postmenopausal Women | Total hip bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline. | Number of Intention to Treat patients with baseline plus at least one post baseline measurement. Last Observation Carried Forward. | Posted | Least Squares Mean | Standard Error | percentage change in total hip BMD | Baseline to 24 weeks |
|
|
|
|
| Secondary | Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Postmenopausal Women | Measures of serum osteocalcin (nanograms per milliliter). Change = Endpoint minus baseline. | Number of Intention to Treat patients with measurements at respective visits. | Posted | Median | Inter-Quartile Range | percentage change in osteocalcin | Baseline to 12 weeks and 24 weeks |
|
|
|
|
| Secondary | Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Men | Lumbar spine bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline. | Number of Intention to Treat patients with baseline plus at least one post baseline measurement. Last Observation Carried Forward. | Posted | Least Squares Mean | Standard Error | percentage change in lumbar spine BMD | Baseline to 24 weeks |
|
|
|
|
| Secondary | Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Men | Total hip bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline. | Number of Intention to Treat patients with baseline plus at least one post baseline measurement. Last Observation Carried Forward. | Posted | Least Squares Mean | Standard Error | percentage change in total hip BMD | Baseline to 24 weeks |
|
|
|
|
| Secondary | Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Men | Measures of serum osteocalcin (nanograms per milliliter). Change = Endpoint minus baseline. | Number of Intention to Treat patients with measurements at respective visit. | Posted | Median | Inter-Quartile Range | percentage change in osteocalcin | Baseline to 12 weeks and 24 weeks |
|
|
|
|
| 8 |
| 67 |
| EG001 | Calcitonin - Females | Intranasal, 200 International Units (IU)/day, 24 weeks | 1 | 26 |
| EG002 | Teriparatide - Males | Subcutaneous, 20 micrograms/day, 24 weeks | 2 | 7 |
| EG003 | Calcitonin - Males | Intranasal, 200 IU/day, 24 weeks | 0 | 0 |
| Angina pectoris | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cardiac discomfort | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cardiac disorder | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Heart valve incompetence | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Sinusitis fungal | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pulmonary infarction | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Arteriosclerosis obliterans | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Thirst | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 11.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
Not provided
| D009750 |
| Nutritional and Metabolic Diseases |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
P-value for Week 24 Percentage Change. |
| 95 |
| No |
| Superiority or Other |
P-value for 24 Week Percentage Change. |
| 95 |
| No |
| Superiority or Other |