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| ID | Type | Description | Link |
|---|---|---|---|
| 2008_596 |
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This study will evaluate the bioequivalence of alendronate in combination with vitamin D (cholecalciferol) compared to alendronate alone and the bioequivalence of vitamin D in combination with alendronate compared to vitamin D alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | alendronate/vitamin D combination then alendronate |
|
| Sequence 2 | Experimental | alendronate then alendronate/vitamin D combination |
|
| Sequence 3 | Experimental | alendronate/vitamin D combination then vitamin D |
|
| Sequence 4 | Experimental | vitamin D then alendronate/vitamin D combination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alendronate sodium (+) cholecalciferol | Drug | A single dose tablet of 70 mg alendronate/2800 IU (international unit) vitamin D in one treatment period of each sequence. There will be a 12 day interval between each treatment period. |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: The Total Urinary Excretion of Alendronate With Alendronate/Vitamin D Combination Tablet Relative to Alendronate Tablet | Urinary excretion of alendronate was determined over a 36-hour period following single-dose administration of a 70 mg alendronate/2800-IU vitamin D3 combination tablet or 70 mg alendronate alone tablet. Urine for each treatment period was collected at -2 to 0 hours predose, 0 to 8, 8 to 24, and 24 to 36 hours postdose. | On Day 1 across the 36-hour urinary collection period (Periods 1 and 2). |
| Part II : The Pharmacokinetic Parameters AUC0-120 hr of Vitamin D in Combination Tablet Relative to Vitamin D Tablet | Serum vitamin D3 pharmacokinetic parameter AUC0-120 hr (area under the serum concentration-time curve) after treatment on Day 1was calculated following single-dose administration of a 70 mg alendronate/2800-IU vitamin D3 combination tablet or 2800-IU vitamin D3 tablet. Serum for each treatment period was collected at -24, -18, -12, -6, and 0 hours predose, and 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose. | On Day 1 across the 120-hour plasma collection period (Periods 1 and 2). |
| Part II : The Pharmacokinetic Parameters Cmax of Vitamin D in Combination Tablet Relative to Vitamin D Tablet | Serum vitamin D3 pharmacokinetic parameter Cmax (maximum concentration observed in serum) after treatmen on Day 1was calculated following single-dose administration of a 70 mg alendronate/2800-IU vitamin D3 combination tablet or 2800-IU vitamin D3 tablet. Serum for each treatment period was collected at -24, -18, -12, -6, and 0 hours predose, and 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose. | On Day 1 across the 120-hour plasma collection period (Periods 1 and 2). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21148044 | Derived | Denker AE, Lazarus N, Porras A, Ramakrishnan R, Constanzer M, Scott BB, Chavez-Eng C, Woolf E, Maganti L, Larson P, Gottesdiener K, Wagner JA. Bioavailability of alendronate and vitamin D(3) in an alendronate/vitamin D(3) combination tablet. J Clin Pharmacol. 2011 Oct;51(10):1439-48. doi: 10.1177/0091270010382010. Epub 2010 Dec 8. |
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A total of 244 participants were enrolled in the study (214 participants were enrolled in Part I and 30 participants were enrolled in Part II).
Participants were recruited from the following clinical research organizations: Thomas Jefferson University, Division of Clinical Pharmacology, Philadelphia, PA; Clinical Pharmacology Associates, Miami, FL; and Northwest Kinetics, Tacoma, WA, between May 2003 and July 2003.
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| ID | Title | Description |
|---|---|---|
| FG000 | Alendronate/Vitamin D Combination Then Alendronate | 70 mg alendronate/2800-IU (international unit) vitamin D3 (cholecalciferol) combination tablet; 70 mg alendronate tablet |
| FG001 | Alendronate Then Alendronate/Vitamin D Combination | 70 mg alendronate tablet; 70 mg alendronate/2800-IU vitamind D3 comination tablet |
| FG002 | Alendronate/Vitamin D Combination Then Vitamin D | 70 mg alendronate/2800-IU vitamind D3 combination tablet; 2800-IU vitamin D3 tablet |
| FG003 | Vitamin D Then Alendronate/Vitamin D Combination | 2800-IU vitamin D3 tablet; 70 mg alendronate/2800-IU vitamin D3 comination tablet |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 - Part I |
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| Period 2 - Part I |
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| Period 1 - Part II |
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| Period 2 - Part II |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Part I | 70 mg alendronate/2800-IU vitamin D3 combination tablet; 70 mg alendronate tablet |
| BG001 | Part II | 2800-IU vitamin D3 tablet; 70 mg alendronate/2800-IU vitamin D3 comination tablet |
| 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 | Part 1: The Total Urinary Excretion of Alendronate With Alendronate/Vitamin D Combination Tablet Relative to Alendronate Tablet | Urinary excretion of alendronate was determined over a 36-hour period following single-dose administration of a 70 mg alendronate/2800-IU vitamin D3 combination tablet or 70 mg alendronate alone tablet. Urine for each treatment period was collected at -2 to 0 hours predose, 0 to 8, 8 to 24, and 24 to 36 hours postdose. | Two hundred-seven (207) subjects (excluding 7 that were enrolled but did not complete both study periods) were included in the statistical analysis. | Posted | Least Squares Mean | Standard Deviation | micrograms (μg) | On Day 1 across the 36-hour urinary collection period (Periods 1 and 2). |
|
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214 subjects were enrolled in Part I of the study & 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm & 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
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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 | Alendronate/Vitamin D Combination | 70 mg alendronate/2800-IU vitamin D3 combination tablet |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Executive Vice President, Clinical and Quantitative Sciences | Merck Sharp & Dohme Corp | 1-800-672-6372 |
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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 |
|---|---|
| D019386 | Alendronate |
| D002762 | Cholecalciferol |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| Comparator: alendronate | Drug | A single dose table of 70 mg alendronate in one treatment period of each sequence. There will be a 12 day interval between each treatment period. |
|
| Comparator: cholecalciferol (Vitamin D) | Dietary Supplement | A single dose tablet of 2800 IU vitamin D in one treatment period of each sequence. There will be a 12 day interval between each treatment period. |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
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| COMPLETED |
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| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Height | Mean | Full Range | Centimeters |
|
| Weight | Mean | Full Range | Kilograms |
|
| OG001 | Alendronate | 70 mg alendronate tablet |
|
|
|
| Primary | Part II : The Pharmacokinetic Parameters AUC0-120 hr of Vitamin D in Combination Tablet Relative to Vitamin D Tablet | Serum vitamin D3 pharmacokinetic parameter AUC0-120 hr (area under the serum concentration-time curve) after treatment on Day 1was calculated following single-dose administration of a 70 mg alendronate/2800-IU vitamin D3 combination tablet or 2800-IU vitamin D3 tablet. Serum for each treatment period was collected at -24, -18, -12, -6, and 0 hours predose, and 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose. | Twenty-eight (28) subjects (excluding 2 that were enrolled but did not complete both study periods) were included in the statistical analysis. | Posted | Least Squares Mean | Standard Deviation | ng*hr/mL | On Day 1 across the 120-hour plasma collection period (Periods 1 and 2). |
|
|
|
|
| Primary | Part II : The Pharmacokinetic Parameters Cmax of Vitamin D in Combination Tablet Relative to Vitamin D Tablet | Serum vitamin D3 pharmacokinetic parameter Cmax (maximum concentration observed in serum) after treatmen on Day 1was calculated following single-dose administration of a 70 mg alendronate/2800-IU vitamin D3 combination tablet or 2800-IU vitamin D3 tablet. Serum for each treatment period was collected at -24, -18, -12, -6, and 0 hours predose, and 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose. | Posted | Least Squares Mean | Standard Deviation | ng/mL | On Day 1 across the 120-hour plasma collection period (Periods 1 and 2). |
|
|
|
|
| 0 |
| 240 |
| 55 |
| 240 |
| EG001 | Alendronate | 70 mg alendronate tablet | 0 | 214 | 39 | 214 |
| EG002 | Vitamin D | 2800-IU vitamin D3 tablet | 0 | 30 | 9 | 30 |
| Keratoconjunctivitis Sicca | Eye disorders | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Non-systematic Assessment |
|
| Intestinal Functional Disorder | Gastrointestinal disorders | Non-systematic Assessment |
|
| Loose Stools | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Retching | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Chest Pain | General disorders | Non-systematic Assessment |
|
| Pain | General disorders | Non-systematic Assessment |
|
| Rigors | General disorders | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Soft Tissue Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Body Temperature Increased | Investigations | Non-systematic Assessment |
|
| Haemoglobin Decreased | Investigations | Non-systematic Assessment |
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| White Blood Cells Urine Positive | Investigations | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Muscle Cramp | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | Non-systematic Assessment |
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| Haematospermia | Reproductive system and breast disorders | Non-systematic Assessment |
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| Menstruation Irregular | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Rhinitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hot Flush | Vascular disorders | Non-systematic Assessment |
|
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D009750 |
| Nutritional and Metabolic Diseases |
| D002782 |
| Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |