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| ID | Type | Description | Link |
|---|---|---|---|
| MK0217A-263 | |||
| 2008_015 |
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To demonstrate the efficacy/safety of Fosamax Plus D
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Alendronate sodium/Cholecalciferol |
|
| 2 | Active Comparator | Alendronate sodium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alendronate sodium (+) cholecalciferol | Drug | Alendronate sodium/Cholecalciferol; tablet, once weekly, for 16 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Below the Deficiency Level (Less Than 15 ng/ml) at 16 Weeks of Treatment | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Serum PTH (Parathyroid Hormone) Percentage Changes From Baseline to 16 Weeks of Treatment | Baseline and 16 weeks |
Not provided
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 |
|---|---|---|---|
| 24719139 | Result | Kim KJ, Min YK, Koh JM, Chung YS, Kim KM, Byun DW, Kim IJ, Kim M, Kim SS, Min KW, Han KO, Park HM, Shin CS, Choi SH, Park JS, Chung DJ, Mok JO, Baek HS, Moon SH, Kim YS, Lim SK; VALUE study group. Efficacy and safety of weekly alendronate plus vitamin D(3) 5600 IU versus weekly alendronate alone in Korean osteoporotic women: 16-week randomized trial. Yonsei Med J. 2014 May;55(3):715-24. doi: 10.3349/ymj.2014.55.3.715. Epub 2014 Apr 1. |
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17 centers participated in this study (11 - Medical Center of the University, 7 - General Hospital).
FPE(First patient enrolled) : March-2008, FPI(First patient in) : April-2008, LPO(Last patient out) : April-2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fosamax Plus D | Once weekly Fosamax plus D tablet [Alendronate sodium 70 mg/Cholecalciferol 5600 IU] + once daily calcium formulation [500 mg/day]), 16 weeks |
| FG001 | Fosamax | Once weekly Fosamax 70 mg tablet [Alendronate sodium 70 mg] + once daily calcium formulation [500 mg/day]), 16 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fosamax Plus D | Once weekly Fosamax plus D tablet [Alendronate sodium 70 mg/Cholecalciferol 5600 IU] + once daily calcium formulation [500 mg/day]), 16 weeks |
| BG001 | Fosamax |
| 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 | Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Below the Deficiency Level (Less Than 15 ng/ml) at 16 Weeks of Treatment | Participants for analysis was modified intention to treat (Number of patients : Fosamax Plus D Group was 136, Fosamax was 132). Missing data were imputed by the last observation carried forward (LOCF) technique. | Posted | Number | participants | 16 weeks |
|
Adverse events were followed up until 14 days after the last dose of investigational drug.
1 Participant from Fosamax Plus D Group and 1 participant from Fosamax Group were not actually administered study drug after randomization and were exclude in AE reporting Group.
1 participant from Fosamax Plus D group was actually administered Fosamax and analyzed as Fosamax Group in AE reporting Group.
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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 | Fosamax Plus D | Once weekly Fosamax plus D tablet [Alendronate sodium 70 mg/Cholecalciferol 5600 IU] + once daily calcium formulation [500 mg/day]), 16 weeks and patients who received drugs at least once after randomization and was analyzed according to the actually administered study drugs |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Herpes zoster | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.0 | 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 |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D019386 | Alendronate |
| D002762 | Cholecalciferol |
| C007792 | Fumigant 93 |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| Comparator: Alendronate sodium (Fosamax) | Drug | Alendronate sodium; tablet, once weekly, for 16 weeks |
|
| Comparator: Calcium | Dietary Supplement | 500 mg oral tablet calcium once daily, for 16 weeks |
|
| Protocol Violation |
|
| Adverse Event |
|
| Visit 3, 25 OHD level ≤9 ng/mL |
|
| Subject's private reason |
|
Once weekly Fosamax 70 mg tablet [Alendronate sodium 70 mg] + once daily calcium formulation [500 mg/day]), 16 weeks
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Patients with/without Vitamin D deficiency | Vitamin D deficiency means serum 25 OHD (hydroxyvitamin D) below the deficiency level (less than 15 ng/ml) in this study. | Number | participants |
|
| T-score classification by inclusion criteria: A fracture in spine Lumbar 1-4 and T-score ≤ -2.0] | T-score: a measurement expressed in standard deviation units from a given mean used in assessment of osteoporosis, equal to a patient's bone mineral density measurement by Dual Energy X-ray Absorptiometry (DEXA) minus the value in a young healthy person, divided by the standard deviation of the measurement in the population. | Number | Participants |
|
| T-score classification by inclusion criteria: Femoral neck T-score ≤ -2.5 | T-score: a measurement expressed in standard deviation units from a given mean used in assessment of osteoporosis, equal to a patient's bone mineral density measurement by DEXA minus the value in a young healthy person, divided by the standard deviation of the measurement in the population. | Number | Participants |
|
| T-score classification by inclusion criteria: Femoral total T-score ≤ -2.5 | T-score: a measurement expressed in standard deviation units from a given mean used in assessment of osteoporosis, equal to a patient's bone mineral density measurement by DEXA minus the value in a young healthy person, divided by the standard deviation of the measurement in the population. | Number | Participants |
|
| T-score classification by inclusion criteria: Spine (average of spine Lumbar 1-4 ) T-score ≤-2.5 | T-score: a measurement expressed in standard deviation units from a given mean used in assessment of osteoporosis, equal to a patient's bone mineral density measurement by DEXA minus the value in a young healthy person, divided by the standard deviation of the measurement in the population. | Number | Participants |
|
| Two or more fractures in spine (Lumbar 1-4) | Number | Participants |
|
| A fracture in spine Lumbar 1, Lumbar 2, Lumbar 3, Lumbar 4 and T-score ≤-2.0 | The analyzable number of patients with A fracture in spine Lumbar 1, Lumbar 2, Lumbar 3, Lumbar 4 and T-score ≤ -2.0 are 9 in Fosamax Plus D Group and 5 in Fosamax Group. | Mean | Standard Deviation | T-score |
|
| Diastolic Blood Pressure | 1 Participant from the Fosamax group is missing data for this Measure | Mean | Standard Deviation | mm Hg |
|
| Femoral neck T-score ≤ -2.5 | The analyzable number of patients with Femoral neck T-score ≤ -2.5 are 43 in Fosamax Plus D Group and 58 in Fosamax Group. | Mean | Standard Deviation | T-score |
|
| Femoral total T-score ≤ -2.5 | The analyzable number of patients with Femoral total T-score ≤ -2.5 are 20 in Fosamax Plus D Group and 25 in Fosamax Group. | Mean | Standard Deviation | T-score |
|
| Height | 2 Participants from the Fosamax group are missing data for this Measure | Mean | Standard Deviation | Centimeters |
|
| Serum PTH (Parathyroid hormone) | Mean | Standard Deviation | pg/ml |
|
| Spine (average of spine Lumbar 1, Lumbar 2, Lumbar 3, Lumbar 4 ) T-score ≤ -2.5 | The analyzable number of patients with Spine (average of spine Lumbar 1, Lumbar 2, Lumbar 3, Lumbar 4) are 144 in Fosamax Plus D Group and 132 in Fosamax Group. | Mean | Standard Deviation | T-score |
|
| Systolic Blood Pressure | 1 Participant from the Fosamax group is missing data for this Measure | Mean | Standard Deviation | mm Hg |
|
| Weight | 1 Participant from the Fosamax plus D group is missing data for this Measure, 2 Participants from the Fosamax group are missing data for this Measure | Mean | Standard Deviation | Kilograms |
|
| serum 25 OHD (Serum 25-hydroxyvitamin D) | Mean | Standard Deviation | ng/ml |
|
| OG001 |
| Fosamax |
Once weekly Fosamax 70 mg tablet [Alendronate sodium 70 mg] + once daily calcium formulation [500 mg/day], 16 weeks and patients who 1) received at least one dose of investigational product, 2) performed efficacy assessment including pre-treatment value and at least one post-treatment value, 3) did not have any major protocol violations including enrollment prior to contract and the violation of drug administration and entry criteria |
|
|
|
| Secondary | Serum PTH (Parathyroid Hormone) Percentage Changes From Baseline to 16 Weeks of Treatment | Participants for analysis was modified intention to treat (Number of patients : Fosamax Plus D Group was 136, Fosamax was 132). Missing data were imputed by the last observation carried forward (LOCF) technique. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change Serum PTH | Baseline and 16 weeks |
|
|
|
|
| Post-Hoc | Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Less and Greater Than 20 ng/ml at 16 Weeks of Treatment | Participants for analysis was modified intention to treat (Number of patients : Fosamax Plus D Group was 136, Fosamax was 132). Missing data were imputed by the last observation carried forward (LOCF) technique. | Posted | Number | participants | 16 weeks |
|
|
|
|
| Post-Hoc | Mean Serum 25 OHD(Serum 25-hydroxyvitamin D) at 16 Weeks of Treatment | Participants for analysis was modified intention to treat (Number of patients : Fosamax Plus D Group was 136, Fosamax was 132). Missing data were imputed by the last observation carried forward (LOCF) technique. | Posted | Mean | Standard Deviation | ng/ml | 16 weeks |
|
|
|
| 7 |
| 171 |
| 60 |
| 171 |
| EG001 | Fosamax | Once weekly Fosamax 70 mg tablet [Alendronate sodium 70 mg] + once daily calcium formulation [500 mg/day]), 16 weeks and patients who received drugs at least once after randomization and was analyzed according to the actually administered study drugs | 1 | 170 | 55 | 170 |
| Lung abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cystocele | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Uterine prolapse | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastritis atrophic | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gingivitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Musculoskeletal disorder | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Onychomycosis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Vaginal infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Thirst | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Xeroderma | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nocturia | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Polyuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dacryostenosis acquired | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 12.0 | 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.
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D002782 |
| Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |