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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001279-19 | EudraCT Number |
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This study will compare the effect of denosumab produced by two different manufacturing processes on bone mineral density at the lumbar spine in postmenopausal women with osteoporosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Denosumab CP2 | Active Comparator | Participants received 60 mg denosumab manufactured using the current CP2 process subcutaneously once every 6 months for 1 year. |
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| Denosumab CP4 | Experimental | Participants received 60 mg denosumab manufactured using the new CP4 process subcutaneously once every 6 months for 1 year. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Denosumab (CP2) | Drug | Denosumab produced by a process referred to as CP2, administered subcutaneously from a prefilled syringe. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Lumbar Spine BMD | Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. | Baseline and Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Serum Type I Collagen C-telopeptide (sCTX) | Baseline, month 1, month 6 and month 12 | |
| Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP) | Baseline, month 1, month 6 and month 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Santa Maria | California | 93454 | United States | ||
| Research Site |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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Ambulatory postmenopausal women 55 years or older with a bone mineral density (BMD) equivalent to a T-score of ≤ 2.5 at lumbar spine, total hip, or femoral neck were eligible to enroll.
Five hundred and forty-seven women were screened; 394 were enrolled and 153 did not meet eligibility criteria.
This study was conducted at 21 centers in Poland, Denmark, United States (US), and Canada. The first participant enrolled on 05 May 2014 and the last participant enrolled on 03 July 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Denosumab CP2 | Participants received 60 mg denosumab manufactured using the current CP2 process subcutaneously once every 6 months for 1 year. |
| FG001 | Denosumab CP4 | Participants received 60 mg denosumab manufactured using the new CP4 process subcutaneously once every 6 months for 1 year. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Denosumab (CP4) | Drug | Denosumab produced by a process referred to as CP4, administered subcutaneously from a prefilled syringe. |
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| South Lake Tahoe |
| California |
| 96150 |
| United States |
| Research Site | Lakewood | Colorado | 80227 | United States |
| Research Site | Gainesville | Georgia | 30501 | United States |
| Research Site | Bethesda | Maryland | 20817 | United States |
| Research Site | Detroit | Michigan | 48236 | United States |
| Research Site | Albuquerque | New Mexico | 87106 | United States |
| Research Site | Akron | Ohio | 44311 | United States |
| Research Site | Bend | Oregon | 97701 | United States |
| Research Site | Duncansville | Pennsylvania | 16635 | United States |
| Research Site | Vancouver | British Columbia | V5Z 4E1 | Canada |
| Research Site | Québec | Quebec | G1V 3M7 | Canada |
| Research Site | Westmout | Quebec | H3Z 1E5 | Canada |
| Research Site | Aalborg | 9000 | Denmark |
| Research Site | Ballerup Municipality | 2750 | Denmark |
| Research Site | Vejle | 7100 | Denmark |
| Research Site | Bialystok | 15-351 | Poland |
| Research Site | Gliwice | 44-100 | Poland |
| Research Site | Krakow | 31-501 | Poland |
| Research Site | Lodz | 90-368 | Poland |
| Research Site | Lodz | 90-558 | Poland |
| Research Site | Świdnik | 21-040 | Poland |
| Research Site | Warsaw | 04-730 | Poland |
| Received Treatment |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Denosumab CP2 | Participants received 60 mg denosumab manufactured using the current CP2 process subcutaneously once every 6 months for 1 year. |
| BG001 | Denosumab CP4 | Participants received 60 mg denosumab manufactured using the new CP4 process subcutaneously once every 6 months for 1 year. |
| 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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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Lumbar Spine Bone Mineral Density (BMD) Score | The T-score is the bone mineral density (BMD) at the site when compared to that of a healthy thirty-year-old. Normal is a T-score of -1.0 or higher; Osteopenia is defined as between -1.0 and -2.5; Osteoporosis is defined as -2.5 or lower, meaning a bone density that is two and a half standard deviations below the mean of a thirty-year-old man/woman. | Mean | Standard Deviation | T-score |
| ||||||||||||||
| Serum Type I Collagen C-telopeptide (CTX-1) | Median | Inter-Quartile Range | ng/mL |
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| Serum Procollagen Type 1 N-terminal Propeptide (P1NP) | Median | Inter-Quartile Range | μg/L |
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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 Lumbar Spine BMD | Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. | The primary efficacy analysis subset included all randomized participants who had a baseline lumbar spine DXA BMD measurement and at least 1 postbaseline lumbar spine DXA BMD measurement. Postbaseline BMD values obtained at the early termination visit were carried forward as the month-12 value. | Posted | Mean | Standard Deviation | percent change | Baseline and Month 12 |
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| Secondary | Percent Change From Baseline in Serum Type I Collagen C-telopeptide (sCTX) | The bone turnover marker (BTM) efficacy analysis subset includes all randomized participants who had a baseline measurement and at least one post baseline measurement. "n" indicates the number of participants with available data at each time point. | Posted | Median | Inter-Quartile Range | percent change | Baseline, month 1, month 6 and month 12 |
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| Secondary | Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP) | The bone turnover marker (BTM) efficacy analysis subset includes all randomized participants who had a baseline measurement and at least one post baseline measurement. "n" indicates the number of participants with available data at each time point. | Posted | Median | Inter-Quartile Range | percent change | Baseline, month 1, month 6 and month 12 |
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12 months
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
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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 | Denosumab CP2 | Participants received 60 mg denosumab manufactured using the current CP2 process subcutaneously once every 6 months for 1 year. | 13 | 196 | 25 | 196 | ||
| EG001 | Denosumab CP4 | Participants received 60 mg denosumab manufactured using the new CP4 process subcutaneously once every 6 months for 1 year. | 6 | 196 | 36 | 196 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
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| Arrhythmia | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA 18.0 | Systematic Assessment |
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| Goitre | Endocrine disorders | MedDRA 18.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
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| Incision site haematoma | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
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| Pulmonary contusion | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
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| Benign ovarian tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
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| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
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| Carotid artery stenosis | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
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| Ischaemic stroke | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
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| Loss of consciousness | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Cholecystectomy | Surgical and medical procedures | MedDRA 18.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
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The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069448 | Denosumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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| ≥ 65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Other |
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Non-inferiority Testing: The lower bound of the 2-sided 95% CI of the between-group difference (denosumab CP4 - denosumab CP2) in percent change from baseline in lumbar spine BMD at 12 months was compared with the non-inferiority margin of -1.44% for assessing non-inferiority. |
| The treatment comparison was analyzed using the analysis of covariance (ANCOVA) model including treatment, baseline BMD value, machine type, and machine type-by-baseline BMD value interaction. The effect of denosumab CP4 on lumbar spine BMD at 12 months relative to the effect of denosumab CP2 was estimated by the least-squares mean of the treatment difference (denosumab CP4 - denosumab CP2) and the corresponding 2-sided 95% confidence interval (CI). | ANCOVA | < 0.001 | Two-sided p-value based on the prespecified equivalence margin of ±1.44% for lumbar spine. | Difference from CP2 | -0.07 | 2-Sided | 95 | -0.72 | 0.57 | Non-Inferiority or Equivalence | Equivalence Testing: The lower and upper bounds of the same 2-sided 95% CI of the between-group difference were compared with the equivalence margin of ±1.44% for assessing equivalence. |
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