Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is structured to estimate the effect of denosumab, compared to placebo and alendronate, on several bone parameters.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 | Placebo Comparator | Placebo for denosumab and placebo for alendronate |
|
| 1 | Experimental | denosumab and placebo for alendronate |
|
| 2 | Active Comparator | Placebo for denosumab and alendronate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alendronate | Drug | Alendronate 70 mg PO QW |
| |
| Denosumab |
| Measure | Description | Time Frame |
|---|---|---|
| Cortical Thickness of Radius by XtremeCT Percent Change From Baseline at Month 12 | Cortical Thickness measured by XtremeCT. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cortical Thickness of Tibia by XtremeCT Percent Change From Baseline at Month 12 | Cortical Thickness measured by XtremeCT. | 12 months |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
-Subjects must not currently be receiving any medication that affects bone metabolism or have an underlying condition that affects their ability to take alendronate or receive denosumab.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20222106 | Background | Seeman E, Delmas PD, Hanley DA, Sellmeyer D, Cheung AM, Shane E, Kearns A, Thomas T, Boyd SK, Boutroy S, Bogado C, Majumdar S, Fan M, Libanati C, Zanchetta J. Microarchitectural deterioration of cortical and trabecular bone: differing effects of denosumab and alendronate. J Bone Miner Res. 2010 Aug;25(8):1886-94. doi: 10.1002/jbmr.81. | |
| 24275677 |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Alendronate 70 mg QW | Alendronate 70 mg QW |
| FG001 | Denosumab 60 mg Q6M | Denosumab 60 mg Q6M |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
denosumab 60 mg SC q 6 mos |
|
| Placebo | Drug | Placebo for alendronate and placebo for denosumab |
|
| Zebaze RM, Libanati C, Austin M, Ghasem-Zadeh A, Hanley DA, Zanchetta JR, Thomas T, Boutroy S, Bogado CE, Bilezikian JP, Seeman E. Differing effects of denosumab and alendronate on cortical and trabecular bone. Bone. 2014 Feb;59:173-9. doi: 10.1016/j.bone.2013.11.016. Epub 2013 Nov 22. |
| 34530172 | Derived | Hu YJ, Chines A, Shi Y, Seeman E, Guo XE. The effect of denosumab and alendronate on trabecular plate and rod microstructure at the distal tibia and radius: A post-hoc HR-pQCT study. Bone. 2022 Jan;154:116187. doi: 10.1016/j.bone.2021.116187. Epub 2021 Sep 14. |
| FG002 |
| Placebo |
Placebo |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Alendronate 70 mg QW | Alendronate 70 mg QW |
| BG001 | Denosumab 60 mg Q6M | Denosumab 60 mg Q6M |
| BG002 | Placebo | Placebo |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Cortical Thickness of Radius by XtremeCT Percent Change From Baseline at Month 12 | Cortical Thickness measured by XtremeCT. | Randomized subjects who receive at least 1 dose of investigational product and have a baseline and at least 1 post baseline evaluation before or at month 12. Last Observation Carried Forward used as imputation method. Summarised for actual treatment taken. | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change from Baseline | 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cortical Thickness of Tibia by XtremeCT Percent Change From Baseline at Month 12 | Cortical Thickness measured by XtremeCT. | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change from Baseline | 12 months |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | 5 | 83 | 78 | 83 | |||
| EG001 | Alendronate 70 mg QW | 5 | 81 | 77 | 81 | |||
| EG002 | Denosumab 60 mg Q6M | 2 | 83 | 76 | 83 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Biliary colic | Hepatobiliary disorders | MedDRA 10.0 |
| ||
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 10.0 |
| ||
| Cholelithiasis | Hepatobiliary disorders | MedDRA 10.0 |
| ||
| Pneumonia | Infections and infestations | MedDRA 10.0 |
| ||
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 10.0 |
| ||
| Adenocarcinoma of the cervix | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 |
| ||
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 |
| ||
| Amnesia | Nervous system disorders | MedDRA 10.0 |
| ||
| Loss of consciousness | Nervous system disorders | MedDRA 10.0 |
| ||
| Confusional state | Psychiatric disorders | MedDRA 10.0 |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 10.0 |
| ||
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 10.0 |
| ||
| Constipation | Gastrointestinal disorders | MedDRA 10.0 |
| ||
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 |
| ||
| Dyspepsia | Gastrointestinal disorders | MedDRA 10.0 |
| ||
| Nausea | Gastrointestinal disorders | MedDRA 10.0 |
| ||
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 |
| ||
| Bronchitis | Infections and infestations | MedDRA 10.0 |
| ||
| Influenza | Infections and infestations | MedDRA 10.0 |
| ||
| Nasopharyngitis | Infections and infestations | MedDRA 10.0 |
| ||
| Pharyngitis | Infections and infestations | MedDRA 10.0 |
| ||
| Urinary tract infection | Infections and infestations | MedDRA 10.0 |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 |
| ||
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 10.0 |
| ||
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 |
| ||
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.0 |
| ||
| Dizziness | Nervous system disorders | MedDRA 10.0 |
| ||
| Headache | Nervous system disorders | MedDRA 10.0 |
| ||
| Paraesthesia | Nervous system disorders | MedDRA 10.0 |
| ||
| Breast mass | Reproductive system and breast disorders | MedDRA 10.0 |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 |
| ||
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 |
| ||
| Hypertension | Vascular disorders | MedDRA 10.0 |
|
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 multi-center 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D019386 | Alendronate |
| D000069448 | Denosumab |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| 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 |
Not provided
Not provided
| Male |
|
| Mean Difference (Final Values) |
| 1 |
| 95 |
| -.6 |
| 2.6 |
| No |
| Superiority or Other |
|