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| ID | Type | Description | Link |
|---|---|---|---|
| 2010_532 | Other Identifier | Merck |
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The purpose of this study is to test the hypothesis that treatment with odanacatib will result in increased bone mineral density (BMD) compared to treatment with placebo. This study will also evaluate the safety and efficacy of odanacatib for male osteoporosis participants.
The original study was divided into two parts, with the primary analysis of endpoints to occur at 24 months and participants will then remain in the study for an additional 12 months (Part 2). Amendment 1 of the protocol removed the additional 12 month period and the Month 36 BMD analysis was deleted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Odanacatib 50 mg once weekly | Experimental | Participants will receive one Odanacatib 50 mg tablet once weekly. In addition, they will receive a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources is approximately 1200 mg. |
|
| Placebo once weekly | Placebo Comparator | Participants will receive one Placebo tablet once weekly. In addition, they will receive a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources is approximately 1200 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Odanacatib | Drug | One 50 mg tablet once weekly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 24 | Lumbar spine BMD was assessed by dual energy X-ray absorptiometry (DXA) at Baseline and at Month 24. | Baseline and Month 24 |
| Number of Participants Who Experienced an Adverse Event (AE) | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. | Up to 24 months (plus 14 days) after first dose of study drug |
| Number of Participants Who Discontinued Treatment Due to an AE | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. | Up to 24 months after first dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline in Total Hip BMD at Month 24 | Total hip BMD was assessed by DXA at Baseline and at Month 24. | Baseline and Month 24 |
| Percentage Change From Baseline in Femoral Neck BMD at Month 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33200257 | Derived | Binkley N, Orwoll E, Chapurlat R, Langdahl BL, Scott BB, Giezek H, Santora AC. Randomized, controlled trial to assess the safety and efficacy of odanacatib in the treatment of men with osteoporosis. Osteoporos Int. 2021 Jan;32(1):173-184. doi: 10.1007/s00198-020-05701-9. Epub 2020 Nov 17. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Odanacatib 50 mg Once Weekly | Participants received one Odanacatib 50 mg tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg. |
| FG001 | Placebo Once Weekly | Participants received one Placebo tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Odanacatib 50 mg Once Weekly | Participants received one Odanacatib 50 mg tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg. |
| 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 in Lumbar Spine Bone Mineral Density (BMD) at Month 24 | Lumbar spine BMD was assessed by dual energy X-ray absorptiometry (DXA) at Baseline and at Month 24. | All randomized participants who took at least one dose of blinded study treatment and had available lumbar spine BMD data for Baseline and Month 24 | Posted | Least Squares Mean | 95% Confidence Interval | Percentage change | Baseline and Month 24 |
|
Up to 24 months (plus 14 days) after first dose of study drug
All randomized participants who took at least one dose of study drug
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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 | Odanacatib 50 mg Once Weekly | Participants received one Odanacatib 50 mg tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza like illness | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| 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 |
|---|---|
| C527128 | odanacatib |
| D002762 | Cholecalciferol |
| D002119 | Calcium Carbonate |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Placebo for Odanacatib | Drug | One 50 mg tablet once weekly |
|
| Vitamin D3 | Dietary Supplement | 5600 IU of open-label Vitamin D3 once weekly |
|
| Calcium carbonate | Dietary Supplement | Sufficient amount of open-label calcium carbonate so that daily calcium intake from both dietary and supplementary sources in approximately 1200 mg |
|
Femoral Neck BMD was assessed by DXA at Baseline and at Month 24.
| Baseline and Month 24 |
| Percentage Change From Baseline in Trochanter BMD at Month 24 | Trochanter BMD was assessed by DXA at Baseline and at Month 24. | Baseline and Month 24 |
| Percentage Change From Baseline in Serum C-Telopeptides of Type 1 Collagen (s-CTx) at Month 24 | Serum samples were collected to evaluate biochemical markers for s-CTx, which were measured at Baseline and at Month 24. | Baseline and Month 24 |
| Percentage Change From Baseline in Urine Collagen N-Telopeptide/Creatinine Ratio (U-NTx/Cr) at Month 24 | Urine samples were collected to evaluate biochemical markers for u-NTx/Cr, which were measured at Baseline and at Month 24. | Baseline and Month 24 |
| Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (s-BSAP) at Month 24 | Serum samples were collected to evaluate biochemical markers for s-BSAP, which were measured at Baseline and at Month 24. | Baseline and Month 24 |
| Percentage Change From Baseline in Serum N-Terminal Propeptides of Type I Collagen (s-P1NP) at Month 24 | Serum samples were collected to evaluate biochemical markers for s-P1NP, which were measured at Baseline and at Month 24. | Baseline and Month 24 |
| Lost to Follow-up |
|
| Physician Decision |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| BG001 |
| Placebo Once Weekly |
Participants received one Placebo tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Placebo Once Weekly |
Participants received one Placebo tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg. |
|
|
|
| Secondary | Percentage Change From Baseline in Total Hip BMD at Month 24 | Total hip BMD was assessed by DXA at Baseline and at Month 24. | All randomized participants who took at least one dose of blinded study treatment and had available total hip BMD data for Baseline and Month 24 | Posted | Least Squares Mean | 95% Confidence Interval | Percentage change | Baseline and Month 24 |
|
|
|
|
| Secondary | Percentage Change From Baseline in Femoral Neck BMD at Month 24 | Femoral Neck BMD was assessed by DXA at Baseline and at Month 24. | All randomized participants who took at least one dose of blinded study treatment and had available femoral neck BMD data for Baseline and Month 24 | Posted | Least Squares Mean | 95% Confidence Interval | Percentage change | Baseline and Month 24 |
|
|
|
|
| Secondary | Percentage Change From Baseline in Trochanter BMD at Month 24 | Trochanter BMD was assessed by DXA at Baseline and at Month 24. | All randomized participants who took at least one dose of blinded study treatment and had available trochanter BMD data for Baseline and Month 24 | Posted | Least Squares Mean | 95% Confidence Interval | Percentage change | Baseline and Month 24 |
|
|
|
|
| Secondary | Percentage Change From Baseline in Serum C-Telopeptides of Type 1 Collagen (s-CTx) at Month 24 | Serum samples were collected to evaluate biochemical markers for s-CTx, which were measured at Baseline and at Month 24. | All randomized participants who had no important deviations from the protocol that may have substantially affected the results, and had available s-CTx data for Baseline and Week 24 | Posted | Least Squares Mean | 95% Confidence Interval | Percentage change | Baseline and Month 24 |
|
|
|
|
| Secondary | Percentage Change From Baseline in Urine Collagen N-Telopeptide/Creatinine Ratio (U-NTx/Cr) at Month 24 | Urine samples were collected to evaluate biochemical markers for u-NTx/Cr, which were measured at Baseline and at Month 24. | All randomized participants who had no important deviations from the protocol that may have substantially affected the results, and had available U-NTx/Cr data for Baseline and Week 24 | Posted | Least Squares Mean | 95% Confidence Interval | Percentage change | Baseline and Month 24 |
|
|
|
|
| Secondary | Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (s-BSAP) at Month 24 | Serum samples were collected to evaluate biochemical markers for s-BSAP, which were measured at Baseline and at Month 24. | All randomized participants who had no important deviations from the protocol that may have substantially affected the results, and had available s-BSAP data for Baseline and Week 24 | Posted | Least Squares Mean | 95% Confidence Interval | Percentage change | Baseline and Month 24 |
|
|
|
|
| Secondary | Percentage Change From Baseline in Serum N-Terminal Propeptides of Type I Collagen (s-P1NP) at Month 24 | Serum samples were collected to evaluate biochemical markers for s-P1NP, which were measured at Baseline and at Month 24. | All randomized participants who had no important deviations from the protocol that may have substantially affected the results, and had available s-P1NP data for Baseline and Week 24 | Posted | Least Squares Mean | 95% Confidence Interval | Percentage change | Baseline and Month 24 |
|
|
|
|
| Primary | Number of Participants Who Experienced an Adverse Event (AE) | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. | All randomized participants who took at least one dose of study drug | Posted | Number | Participants | Up to 24 months (plus 14 days) after first dose of study drug |
|
|
|
| Primary | Number of Participants Who Discontinued Treatment Due to an AE | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. | All randomized participants who took at least one dose of study drug | Posted | Number | Participants | Up to 24 months after first dose of study drug |
|
|
|
| 24 |
| 146 |
| 30 |
| 146 |
| EG001 | Placebo Once Weekly | Participants received one Placebo tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg. | 24 | 146 | 44 | 146 |
| Angina unstable | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Atrioventricular block second degree | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Sick sinus syndrome | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hydrocele | Congenital, familial and genetic disorders | MedDRA 16.1 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Alcoholic liver disease | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cholelithiasis obstructive | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Arthritis infective | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Peritonitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Retroperitoneal infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Fractured sacrum | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Heat exhaustion | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Ilium fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Postoperative hernia | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Benign gastric neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Haemangioma of bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Calculus ureteric | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.
| D009750 |
| Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D008903 | Minerals |