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| ID | Type | Description | Link |
|---|---|---|---|
| 2007_653 |
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A study designed to see if the study drug will increase blood levels of vitamin D, bone mineral density (BMD), improve biochemical markers of bone turnover, and reduce the number of falls as compared to women receiving standard care for osteoporosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FOSAVANCE 5600 | Experimental | alendronate sodium (+) cholecalciferol |
|
| Referred-Care Model | Other | Usual treatment for osteoporosis chosen and prescribed by patients' own physicians. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FOSAVANCE 5600 (Alendronate Sodium (+) cholecalciferol) | Drug | FOSAVANCE 5600 international units (IU)(Alendronate Sodium 70 mg/Vitamin D 5600 IU) combination tablet once weekly for 6 months (Week 26) during the base period and an additional 6-month extension period (Week 52). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 26 | Percentage of participants with serum levels of 25-hydroxyvitamin D below 20 nanograms/milliliter (ng/mL) after 26 weeks of treatment with FOSAVANCE 5600 once weekly versus Referred-Care in postmenopausal women with osteoporosis and at increased risk of falls. | Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline at Week 26 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio | N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio (NTx) is a urine biochemical marker of bone resorption and measured in nanomoles (nmol) Bone Collagen Equivalents (BCE)/millimoles (mmol) creatinine. The percent change was calculated as: [100 * ((Week 26/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy. |
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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 |
|---|---|---|---|
| 21479913 | Background | Ralston SH, Binkley N, Boonen S, Kiel DP, Reginster JY, Roux C, Chen L, Rosenberg E, Santora A; FOCUS-D (FOSAVANCE vs. Standard Care-Use and Study of Vitamin D) Trial. Randomized trial of alendronate plus vitamin D3 versus standard care in osteoporotic postmenopausal women with vitamin D insufficiency. Calcif Tissue Int. 2011 Jun;88(6):485-94. doi: 10.1007/s00223-011-9482-4. Epub 2011 Apr 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | FOSAVANCE 5600 | Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement. |
| FG001 | Referred-Care | Usual treatment for osteoporosis chosen and prescribed by patients' own physicians. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FOSAVANCE 5600 | Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement. |
| BG001 | Referred-Care | Usual treatment for osteoporosis chosen and prescribed by patients' own physicians. |
| 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 of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 26 | Percentage of participants with serum levels of 25-hydroxyvitamin D below 20 nanograms/milliliter (ng/mL) after 26 weeks of treatment with FOSAVANCE 5600 once weekly versus Referred-Care in postmenopausal women with osteoporosis and at increased risk of falls. | Full Analysis Set Population (FAS) included participants who took at least one dose of study therapy during the entire treatment period of FOSAVANCE 5600 or who were assigned to receive regular care and had data reported at least once post-randomization during the entire study period, and had efficacy measurements during the entire study period. | Posted | Number | Percentage of Participants | Week 26 |
|
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FOSAVANCE 5600 group: participants who took at least 1 dose were included (254 out of 257 patients). All patients randomized in the referred-care group were included regardless of whether they took 1 dose of therapy as prescribed by their physicians.
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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 | FOSAVANCE 5600 | Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Unstable | Cardiac disorders | MedDRA (13.0) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.0) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 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 |
|---|---|
| D019386 | Alendronate |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| Calcium Supplement 500 mg | Dietary Supplement | Calcium supplied locally by the investigator (containing 500 mg calcium supplement) daily for 52 weeks (unless the patient's dietary intake of calcium exceeds 1000 mg per day). |
|
| Referred-Care Model | Other | Usual treatment for osteoporosis chosen and prescribed by patients' own physicians for 6 months (Week 26) during the base period and an additional 6-month extension period (Week 52). |
|
| Baseline and Week 26 |
| Percent Change From Baseline at Week 26 in Bone-Specific Alkaline Phosphatase | Bone-Specific Alkaline Phosphatase (BSAP) is a serum biochemical marker of bone formation and measured in micrograms/Liter (mcg/L). The percent change was calculated as: [100 * ((Week 26/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy. | Baseline and Week 26 |
| Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 52 | Percentage of participants with serum levels of 25-hydroxyvitamin D below 20 ng/mL after 52 weeks of treatment (6 month extension study) with FOSAVANCE 5600 once weekly versus Referred-Care in postmenopausal women with osteoporosis and at increased risk of falls. | Week 52 |
| Percent Change From Baseline in Lumbar Spine and Total Hip Bone Mineral Density | Bone Mineral Density (BMD) as measured by Dual Energy X-Ray Absorptiometry (DEXA) and measured in g/cm^2 was obtained at baseline (visit 1) and Week 52 (visit 13) or at early study discontinuation visit. The percent change was calculated as: [100 * ((Week 52/Baseline)-1)]. The greater the percent change from baseline, the greater the response to therapy. | Baseline and Week 52 |
| Falls Per Participant | Number of falls per participant was measured. The fall event rate during the study period was defined as the number of adjudicated falls during the study period divided by the total patient-years in the study. Each participant was to be in the study for approximately one year. In order to guide and standardize all procedures during the fall adjudication process, a Standard Operating Procedure for Fall Adjudication was created by the SPONSOR and served as a guideline to standardize operational procedures for fall adjudication. | Up to Week 52 |
| Percent Change From Baseline at Week 52 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio | NTx is a urine biochemical marker of bone resorption and measured in nanomoles (nmol) Bone Collagen Equivalents (BCE)/millimoles (mmol) creatinine. The percent change was calculated as: [100 * ((Week 52/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy. | Baseline and Week 52 |
| Percent Change From Baseline at Week 52 in Bone-Specific Alkaline Phosphatase | BSAP is a serum biochemical marker of bone formation and measured in micrograms/Liter (mcg/L). The percent change was calculated as: [100 * ((Week 52/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy. | Baseline and Week 52 |
| Physician Decision |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Referred-Care | Usual treatment for osteoporosis chosen and prescribed by patients' own physicians. |
|
|
|
| Secondary | Percent Change From Baseline at Week 26 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio | N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio (NTx) is a urine biochemical marker of bone resorption and measured in nanomoles (nmol) Bone Collagen Equivalents (BCE)/millimoles (mmol) creatinine. The percent change was calculated as: [100 * ((Week 26/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy. | Per-Protocol Population: excluded participants due to important deviations from the protocol that may substantially affect the results of the primary efficacy analysis. | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change | Baseline and Week 26 |
|
|
|
|
| Secondary | Percent Change From Baseline at Week 26 in Bone-Specific Alkaline Phosphatase | Bone-Specific Alkaline Phosphatase (BSAP) is a serum biochemical marker of bone formation and measured in micrograms/Liter (mcg/L). The percent change was calculated as: [100 * ((Week 26/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy. | Per-Protocol Population: excluded participants due to important deviations from the protocol that may substantially affect the results of the primary efficacy analysis. | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change | Baseline and Week 26 |
|
|
|
|
| Secondary | Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 52 | Percentage of participants with serum levels of 25-hydroxyvitamin D below 20 ng/mL after 52 weeks of treatment (6 month extension study) with FOSAVANCE 5600 once weekly versus Referred-Care in postmenopausal women with osteoporosis and at increased risk of falls. | The FAS population included participants who took at least one dose of study therapy during the entire treatment period of FOSAVANCE 5600 or who were assigned to receive regular care and had data reported at least once post-randomization during the entire study period, and had efficacy measurements during the entire study period. | Posted | Number | Percentage of Participants | Week 52 |
|
|
|
|
| Secondary | Percent Change From Baseline in Lumbar Spine and Total Hip Bone Mineral Density | Bone Mineral Density (BMD) as measured by Dual Energy X-Ray Absorptiometry (DEXA) and measured in g/cm^2 was obtained at baseline (visit 1) and Week 52 (visit 13) or at early study discontinuation visit. The percent change was calculated as: [100 * ((Week 52/Baseline)-1)]. The greater the percent change from baseline, the greater the response to therapy. | The FAS population included participants who took at least one dose of study therapy during the entire treatment period of FOSAVANCE 5600 or who were assigned to receive regular care and had data reported at least once post-randomization during the entire study period, and had efficacy measurements during the entire study period. | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change | Baseline and Week 52 |
|
|
|
|
| Secondary | Falls Per Participant | Number of falls per participant was measured. The fall event rate during the study period was defined as the number of adjudicated falls during the study period divided by the total patient-years in the study. Each participant was to be in the study for approximately one year. In order to guide and standardize all procedures during the fall adjudication process, a Standard Operating Procedure for Fall Adjudication was created by the SPONSOR and served as a guideline to standardize operational procedures for fall adjudication. | Intent-to-Treat (ITT) population included all randomized participants within the treatment group to which they were randomized regardless of whether or not a participant may have dropped out in the base or continued into the extension study. | Posted | Mean | Standard Deviation | Number of Falls | Up to Week 52 |
|
|
|
|
| Secondary | Percent Change From Baseline at Week 52 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio | NTx is a urine biochemical marker of bone resorption and measured in nanomoles (nmol) Bone Collagen Equivalents (BCE)/millimoles (mmol) creatinine. The percent change was calculated as: [100 * ((Week 52/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy. | Per-Protocol Population: excluded patients due to important deviations from the protocol that may substantially affect the results of the primary efficacy analysis. | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change | Baseline and Week 52 |
|
|
|
|
| Secondary | Percent Change From Baseline at Week 52 in Bone-Specific Alkaline Phosphatase | BSAP is a serum biochemical marker of bone formation and measured in micrograms/Liter (mcg/L). The percent change was calculated as: [100 * ((Week 52/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy. | Per-Protocol Population: excluded patients due to important deviations from the protocol that may substantially affect the results of the primary efficacy analysis. | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change | Baseline and Week 52 |
|
|
|
|
| 25 |
| 254 |
| 61 |
| 254 |
| EG001 | Referred-Care | Usual treatment for osteoporosis chosen and prescribed by patients' own physicians. | 29 | 258 | 70 | 258 |
| Atrial Fibrillation | Cardiac disorders | MedDRA (13.0) |
|
| Cardiac Failure | Cardiac disorders | MedDRA (13.0) |
|
| Coronary Artery Disease | Cardiac disorders | MedDRA (13.0) |
|
| Electromechanical Dissociation | Cardiac disorders | MedDRA (13.0) |
|
| Myocardial Infarction | Cardiac disorders | MedDRA (13.0) |
|
| Sick Sinus Syndrome | Cardiac disorders | MedDRA (13.0) |
|
| Eye Haemorrhage | Eye disorders | MedDRA (13.0) |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (13.0) |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.0) |
|
| Faecaloma | Gastrointestinal disorders | MedDRA (13.0) |
|
| Gastric Ulcer | Gastrointestinal disorders | MedDRA (13.0) |
|
| Gastroesophageal Reflux Disease | Gastrointestinal disorders | MedDRA (13.0) |
|
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA (13.0) |
|
| Retroperitoneal Haemorrhage | Gastrointestinal disorders | MedDRA (13.0) |
|
| Vomiting | Gastrointestinal disorders | MedDRA (13.0) |
|
| Chest Pain | General disorders | MedDRA (13.0) |
|
| Local Swelling | General disorders | MedDRA (13.0) |
|
| Non-Cardiac Chest Pain | General disorders | MedDRA (13.0) |
|
| Pyrexia | General disorders | MedDRA (13.0) |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (13.0) |
|
| Bacterial Diarrhoea | Infections and infestations | MedDRA (13.0) |
|
| Bronchitis | Infections and infestations | MedDRA (13.0) |
|
| Diverticulitis | Infections and infestations | MedDRA (13.0) |
|
| Enterovirus Infection | Infections and infestations | MedDRA (13.0) |
|
| Gastroenteritis Viral | Infections and infestations | MedDRA (13.0) |
|
| Malaria | Infections and infestations | MedDRA (13.0) |
|
| Peritonsillar Abscess | Infections and infestations | MedDRA (13.0) |
|
| Pneumonia | Infections and infestations | MedDRA (13.0) |
|
| Sepsis | Infections and infestations | MedDRA (13.0) |
|
| Subacute Endocarditis | Infections and infestations | MedDRA (13.0) |
|
| Urinary Tract Infection | Infections and infestations | MedDRA (13.0) |
|
| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA (13.0) |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (13.0) |
|
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA (13.0) |
|
| Meniscus Lesion | Injury, poisoning and procedural complications | MedDRA (13.0) |
|
| Pubis Fracture | Injury, poisoning and procedural complications | MedDRA (13.0) |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (13.0) |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) |
|
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA (13.0) |
|
| Lumbar Spinal Stenosis | Musculoskeletal and connective tissue disorders | MedDRA (13.0) |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (13.0) |
|
| Spinal Column Stenosis | Musculoskeletal and connective tissue disorders | MedDRA (13.0) |
|
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) |
|
| Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) |
|
| Oesophageal Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) |
|
| Ovarian Epithelial Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) |
|
| Pancreatic Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) |
|
| Uterine Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) |
|
| Carotid Artery Stenosis | Nervous system disorders | MedDRA (13.0) |
|
| Cerebral Ischaemia | Nervous system disorders | MedDRA (13.0) |
|
| Cerebrovascular Accident | Nervous system disorders | MedDRA (13.0) |
|
| Facial Palsy | Nervous system disorders | MedDRA (13.0) |
|
| Radiculopathy | Nervous system disorders | MedDRA (13.0) |
|
| Transient Ischaemic Attack | Nervous system disorders | MedDRA (13.0) |
|
| Unresponsive to Stimuli | Nervous system disorders | MedDRA (13.0) |
|
| Vascular Dementia | Nervous system disorders | MedDRA (13.0) |
|
| Haematuria | Renal and urinary disorders | MedDRA (13.0) |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (13.0) |
|
| Renal Artery Stenosis | Renal and urinary disorders | MedDRA (13.0) |
|
| Renal Failure Acute | Renal and urinary disorders | MedDRA (13.0) |
|
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) |
|
| Pulmonary Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) |
|
| Orthostatic Hypotension | Vascular disorders | MedDRA (13.0) |
|
| Peripheral Arterial Occlusive disease | Vascular disorders | MedDRA (13.0) |
|
| Thrombophlebitis Superficial | Vascular disorders | MedDRA (13.0) |
|
| Urinary Tract Infection | Infections and infestations | MedDRA (13.0) |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (13.0) |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (13.0) |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) |
|
| Dizziness | Nervous system disorders | MedDRA (13.0) |
|
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. SPONSOR review can be expedited to meet publication guidelines.
| 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 |
| Traditional Longitudinal data analysis |
The model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region. |
| 0.035 |
| Least Squares Mean Difference |
| 0.82 |
| 95 |
| 0.06 |
| 1.58 |
FOSAVANCE minus Referred-Care. Analysis was for Total Hip. |
| Superiority or Other (legacy) |