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This study will assess the effect of 26 weeks of once-weekly treatment with MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (Fosamax Plus 70/5600) on serum levels of 25-hydroxyvitamin D [25(OH)D].
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fosamax Plus | Experimental | Calcium supplement (elemental calcium and/or calcium carbonate) without vitamin D will also be supplied to participants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet | Drug | One combination tablet orally once a week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serum 25-hydroxyvitamin D >=50 ng/mL at Week 26 | Serum samples to measure serum 25-hydroxyvitamin D [25(OH)D] will be collected at specific visits during the treatment phase of the study. | Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change From Baseline of Bone Resorption Marker of Serum Beta-CrossLaps at Week 26 | Serum samples for Beta-CrossLaps (β-CTx) will be collected at specific visits during the treatment phase of the study. | Baseline and Week 26 |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30400864 | Derived | Songpatanasilp T, Rojanasthien S, Sugkraroek P, Ongphiphadhanakul B, Robert L, Robert CS, Luevitoonvechkij S, Santora AC. Open-label study of treatment with alendronate sodium plus vitamin D in men and women with osteoporosis in Thailand. BMC Musculoskelet Disord. 2018 Nov 6;19(1):392. doi: 10.1186/s12891-018-2309-y. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fosamax Plus: All Participants | All participants who were enrolled in the study to receive one oral combination tablet of Fosamax Plus weekly. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline Analysis was performed on the All Patients as Treated (APaT) population, which included all participants who received treatment. Of 200 participants enrolled in the study, baseline data were not provided for two participants who did not receive treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Fosamax Plus: All Treated Participants | All participants who received at least one oral dose combination tablet of Fosamax Plus. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age data were not reported for 2 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 | Number of Participants With Serum 25-hydroxyvitamin D >=50 ng/mL at Week 26 | Serum samples to measure serum 25-hydroxyvitamin D [25(OH)D] will be collected at specific visits during the treatment phase of the study. | Full Analysis Set (FAS) consisted of participants who received >=1 dose of study drug; had >=1 post-baseline observation for the analysis endpoint; and had baseline data. For analysis, participants in the FAS were categorized into 3 subgroups by osteoporosis therapy received at baseline: Recent/Current, Other therapy, and Treatment Naïve | Posted | Number | Participants | Week 26 |
|
Up to Week 26
Of 200 participants enrolled in the study, two participants did not receive treatment and were not evaluated for safety.
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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: All Treated Participants | All participants who received at least one oral dose combination tablet of Fosamax Plus. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspepsia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | 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 |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| D019386 | Alendronate |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Physician Decision |
|
| Lost to Follow-up |
|
| Protocol Violation |
|
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Gender data were not reported for 2 participants. | Count of Participants | Participants |
|
| OG001 | Fosamax Plus: Other Osteoporosis Therapy at Baseline | Participants receiving other osteoporosis drugs at baseline (besides bisphosphonate, strontium, estrogen, or SERM) were administered open-label alendronate sodium 70 mg+Vitamin D3 5600 IU combination tablet (Fosamax Plus D) orally once a week for 26 weeks. |
| OG002 | Fosamax Plus: Treatment Naive at Baseline | Participants that were treatment-naïve or not recently treated at baseline were administered open-label alendronate sodium 70 mg+Vitamin D3 5600 IU combination tablet (Fosamax Plus D) orally once a week for 26 weeks. |
| OG003 | Fosamax Plus: All Treated Participants | All participants who received at least one oral dose combination tablet of Fosamax Plus. |
|
|
| Secondary | Mean Percent Change From Baseline of Bone Resorption Marker of Serum Beta-CrossLaps at Week 26 | Serum samples for Beta-CrossLaps (β-CTx) will be collected at specific visits during the treatment phase of the study. | Per Protocol Population consisted of FAS but excluded participants who had important deviations from protocol or did not complete study on study drug. For analysis, participants in Per Protocol Population were categorized into 3 subgroups by osteoporosis therapy received at baseline: Recent/Current, Other therapy, and Treatment Naïve. | Posted | Mean | Standard Deviation | Percent change | Baseline and Week 26 |
|
|
|
| 4 |
| 198 |
| 10 |
| 198 |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Femur fracture | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Tongue neoplasm, malignant stage, unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
|
Investigators agreed to allow the Sponsor to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Investigators have also agreed that 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 |
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |