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Trial record 14 of 842 for:    osteoporosis AND (woman OR women OR female)

A Study to Test the Effect of MK0217A on Vitamin D Inadequacy in Postmenopausal Women With Osteoporosis (0217A-262)

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ClinicalTrials.gov Identifier: NCT00692913
Recruitment Status : Completed
First Posted : June 6, 2008
Results First Posted : August 15, 2011
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Osteoporosis
Interventions Drug: FOSAVANCE 5600 (Alendronate Sodium (+) cholecalciferol)
Dietary Supplement: Calcium Supplement 500 mg
Other: Referred-Care Model
Enrollment 515

Recruitment Details  
Pre-assignment Details  
Arm/Group Title FOSAVANCE 5600 Referred-Care
Hide Arm/Group Description Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement. Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
Period Title: Overall Study
Started 257 258
Completed 228 228
Not Completed 29 30
Reason Not Completed
Adverse Event             8             4
Lost to Follow-up             3             5
Physician Decision             2             0
Protocol Violation             1             1
Withdrawal by Subject             15             20
Arm/Group Title FOSAVANCE 5600 Referred-Care Total
Hide Arm/Group Description Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement. Usual treatment for osteoporosis chosen and prescribed by patients' own physicians. Total of all reporting groups
Overall Number of Baseline Participants 257 258 515
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 257 participants 258 participants 515 participants
72.9  (5.3) 72.9  (5.9) 72.9  (5.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 257 participants 258 participants 515 participants
Female
257
 100.0%
258
 100.0%
515
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 26
Hide Description

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.

Time Frame Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title FOSAVANCE 5600 Referred-Care
Hide Arm/Group Description:
Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
Overall Number of Participants Analyzed 221 216
Measure Type: Number
Unit of Measure: Percentage of Participants
8.6 31.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FOSAVANCE 5600, Referred-Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments The logistic regression model was adjusted by baseline 25-hydroxyvitamin D (25(OH)D) level stratum, age, and region.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.20
Confidence Interval 95%
0.12 to 0.35
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percent Change From Baseline at Week 26 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio
Hide Description 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.
Time Frame Baseline and Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Population: excluded participants due to important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.
Arm/Group Title FOSAVANCE 5600 Referred-Care
Hide Arm/Group Description:
Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
Overall Number of Participants Analyzed 216 226
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Change
-57.06
(-60.19 to -53.68)
-47.36
(-51.23 to -43.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FOSAVANCE 5600, Referred-Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Longitudinal Data Analysis Model
Comments The model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.
Method of Estimation Estimation Parameter Difference in Least-squares means
Estimated Value -9.70
Confidence Interval 95%
-14.49 to -4.93
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percent Change From Baseline at Week 26 in Bone-Specific Alkaline Phosphatase
Hide Description 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.
Time Frame Baseline and Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Population: excluded participants due to important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.
Arm/Group Title FOSAVANCE 5600 Referred-Care
Hide Arm/Group Description:
Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
Overall Number of Participants Analyzed 223 237
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Change
-46.67
(-49.32 to -43.88)
-39.60
(-42.60 to -36.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FOSAVANCE 5600, Referred-Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Longitudinal Data Analysis Model
Comments The model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.
Method of Estimation Estimation Parameter Difference in Least-squares mean
Estimated Value -7.07
Confidence Interval 95%
-10.95 to -3.20
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 52
Hide Description

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.

Time Frame Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FOSAVANCE 5600 Referred-Care
Hide Arm/Group Description:
Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
Overall Number of Participants Analyzed 212 203
Measure Type: Number
Unit of Measure: Percentage of Participants
11.3 36.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FOSAVANCE 5600, Referred-Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments The logistic regression model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.21
Confidence Interval 95%
0.13 to 0.35
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percent Change From Baseline in Lumbar Spine and Total Hip Bone Mineral Density
Hide Description 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.
Time Frame Baseline and Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FOSAVANCE 5600 Referred-Care
Hide Arm/Group Description:
Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
Overall Number of Participants Analyzed 227 219
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Change
Lumbar Spine (n= 226/ n=219)
4.92
(4.17 to 5.66)
3.91
(3.16 to 4.66)
Total Hip (n=227/ n=218)
2.22
(1.65 to 2.79)
1.40
(0.83 to 1.97)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FOSAVANCE 5600, Referred-Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.047
Comments [Not Specified]
Method Traditional Longitudinal data analysis
Comments The model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 1.01
Confidence Interval 95%
0.01 to 2.00
Estimation Comments FOSAVANCE minus Referred-Care. Analysis was for Lumbar Spine.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FOSAVANCE 5600, Referred-Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.035
Comments [Not Specified]
Method Traditional Longitudinal data analysis
Comments The model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.82
Confidence Interval 95%
0.06 to 1.58
Estimation Comments FOSAVANCE minus Referred-Care. Analysis was for Total Hip.
6.Secondary Outcome
Title Falls Per Participant
Hide Description

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.

Time Frame Up to Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FOSAVANCE 5600 Referred-Care
Hide Arm/Group Description:
Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
Overall Number of Participants Analyzed 257 258
Mean (Standard Deviation)
Unit of Measure: Number of Falls
0.51  (1.53) 0.45  (0.80)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FOSAVANCE 5600, Referred-Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.675
Comments [Not Specified]
Method Zero-Inflated Poisson Regression
Comments Adjusted by the terms for treatment, baseline 25(OH) D level stratum, age, and region and offset variable of log (total patient-years in the study).
Method of Estimation Estimation Parameter Difference of falls (falls/patient-year)
Estimated Value 0.03
Confidence Interval 95%
-0.12 to 0.19
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.08
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percent Change From Baseline at Week 52 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio
Hide Description 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.
Time Frame Baseline and Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Population: excluded patients due to important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.
Arm/Group Title FOSAVANCE 5600 Referred-Care
Hide Arm/Group Description:
Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
Overall Number of Participants Analyzed 216 227
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Change
-58.42
(-61.58 to -54.99)
-50.07
(-54.01 to -45.79)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FOSAVANCE 5600, Referred-Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Longitudinal Data Analysis Model
Comments The model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.
Method of Estimation Estimation Parameter Difference in Least Squares Means
Estimated Value -8.35
Confidence Interval 95%
-13.19 to -3.54
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percent Change From Baseline at Week 52 in Bone-Specific Alkaline Phosphatase
Hide Description 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.
Time Frame Baseline and Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Population: excluded patients due to important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.
Arm/Group Title FOSAVANCE 5600 Referred-Care
Hide Arm/Group Description:
Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
Overall Number of Participants Analyzed 223 237
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent Change
-51.21
(-53.79 to -48.48)
-43.13
(-46.18 to -39.91)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FOSAVANCE 5600, Referred-Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Longitudinal Data Analysis Model
Comments The model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -8.07
Confidence Interval 95%
-11.94 to -4.21
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description 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.
 
Arm/Group Title FOSAVANCE 5600 Referred-Care
Hide Arm/Group Description Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement. Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
All-Cause Mortality
FOSAVANCE 5600 Referred-Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
FOSAVANCE 5600 Referred-Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   25/254 (9.84%)      29/258 (11.24%)    
Cardiac disorders     
Angina Unstable  0/254 (0.00%)  0 1/258 (0.39%)  1
Atrial Fibrillation  3/254 (1.18%)  3 1/258 (0.39%)  2
Cardiac Failure  1/254 (0.39%)  1 0/258 (0.00%)  0
Coronary Artery Disease  2/254 (0.79%)  2 0/258 (0.00%)  0
Electromechanical Dissociation  1/254 (0.39%)  1 0/258 (0.00%)  0
Myocardial Infarction  0/254 (0.00%)  0 1/258 (0.39%)  1
Sick Sinus Syndrome  1/254 (0.39%)  1 0/258 (0.00%)  0
Eye disorders     
Eye Haemorrhage  0/254 (0.00%)  0 1/258 (0.39%)  1
Gastrointestinal disorders     
Abdominal Pain Upper  0/254 (0.00%)  0 1/258 (0.39%)  1
Diarrhoea  1/254 (0.39%)  1 0/258 (0.00%)  0
Faecaloma  0/254 (0.00%)  0 1/258 (0.39%)  1
Gastric Ulcer  1/254 (0.39%)  1 0/258 (0.00%)  0
Gastroesophageal Reflux Disease  1/254 (0.39%)  1 0/258 (0.00%)  0
Intestinal Obstruction  0/254 (0.00%)  0 1/258 (0.39%)  1
Retroperitoneal Haemorrhage  1/254 (0.39%)  1 0/258 (0.00%)  0
Vomiting  0/254 (0.00%)  0 1/258 (0.39%)  1
General disorders     
Chest Pain  1/254 (0.39%)  1 0/258 (0.00%)  0
Local Swelling  0/254 (0.00%)  0 1/258 (0.39%)  1
Non-Cardiac Chest Pain  1/254 (0.39%)  1 1/258 (0.39%)  1
Pyrexia  1/254 (0.39%)  1 0/258 (0.00%)  0
Hepatobiliary disorders     
Cholelithiasis  0/254 (0.00%)  0 1/258 (0.39%)  1
Infections and infestations     
Bacterial Diarrhoea  0/254 (0.00%)  0 1/258 (0.39%)  1
Bronchitis  1/254 (0.39%)  1 0/258 (0.00%)  0
Diverticulitis  0/254 (0.00%)  0 1/258 (0.39%)  1
Enterovirus Infection  0/254 (0.00%)  0 1/258 (0.39%)  1
Gastroenteritis Viral  1/254 (0.39%)  1 0/258 (0.00%)  0
Malaria  1/254 (0.39%)  1 0/258 (0.00%)  0
Peritonsillar Abscess  1/254 (0.39%)  1 0/258 (0.00%)  0
Pneumonia  0/254 (0.00%)  0 1/258 (0.39%)  1
Sepsis  1/254 (0.39%)  1 0/258 (0.00%)  0
Subacute Endocarditis  1/254 (0.39%)  1 0/258 (0.00%)  0
Urinary Tract Infection  1/254 (0.39%)  1 0/258 (0.00%)  0
Injury, poisoning and procedural complications     
Ankle Fracture  1/254 (0.39%)  1 0/258 (0.00%)  0
Contusion  0/254 (0.00%)  0 2/258 (0.78%)  2
Hip Fracture  0/254 (0.00%)  0 2/258 (0.78%)  2
Meniscus Lesion  0/254 (0.00%)  0 1/258 (0.39%)  1
Pubis Fracture  0/254 (0.00%)  0 1/258 (0.39%)  1
Metabolism and nutrition disorders     
Dehydration  0/254 (0.00%)  0 1/258 (0.39%)  1
Musculoskeletal and connective tissue disorders     
Back Pain  1/254 (0.39%)  1 1/258 (0.39%)  1
Intervertebral Disc Protrusion  0/254 (0.00%)  0 1/258 (0.39%)  1
Lumbar Spinal Stenosis  0/254 (0.00%)  0 1/258 (0.39%)  1
Osteoarthritis  0/254 (0.00%)  0 1/258 (0.39%)  1
Spinal Column Stenosis  1/254 (0.39%)  1 1/258 (0.39%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal Cell Carcinoma  1/254 (0.39%)  1 2/258 (0.78%)  3
Colon Cancer  0/254 (0.00%)  0 1/258 (0.39%)  1
Oesophageal Squamous Cell Carcinoma  1/254 (0.39%)  1 0/258 (0.00%)  0
Ovarian Epithelial Cancer  1/254 (0.39%)  1 0/258 (0.00%)  0
Pancreatic Carcinoma  1/254 (0.39%)  1 0/258 (0.00%)  0
Uterine Cancer  1/254 (0.39%)  1 0/258 (0.00%)  0
Nervous system disorders     
Carotid Artery Stenosis  0/254 (0.00%)  0 1/258 (0.39%)  1
Cerebral Ischaemia  1/254 (0.39%)  1 0/258 (0.00%)  0
Cerebrovascular Accident  1/254 (0.39%)  1 0/258 (0.00%)  0
Facial Palsy  0/254 (0.00%)  0 1/258 (0.39%)  1
Radiculopathy  1/254 (0.39%)  1 0/258 (0.00%)  0
Transient Ischaemic Attack  0/254 (0.00%)  0 1/258 (0.39%)  1
Unresponsive to Stimuli  1/254 (0.39%)  1 0/258 (0.00%)  0
Vascular Dementia  0/254 (0.00%)  0 1/258 (0.39%)  1
Renal and urinary disorders     
Haematuria  0/254 (0.00%)  0 1/258 (0.39%)  1
Nephrolithiasis  0/254 (0.00%)  0 1/258 (0.39%)  1
Renal Artery Stenosis  0/254 (0.00%)  0 1/258 (0.39%)  1
Renal Failure Acute  1/254 (0.39%)  1 0/258 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute Respiratory Failure  1/254 (0.39%)  1 0/258 (0.00%)  0
Dyspnoea  1/254 (0.39%)  2 0/258 (0.00%)  0
Pulmonary Congestion  1/254 (0.39%)  1 0/258 (0.00%)  0
Respiratory Failure  1/254 (0.39%)  1 0/258 (0.00%)  0
Vascular disorders     
Orthostatic Hypotension  0/254 (0.00%)  0 1/258 (0.39%)  1
Peripheral Arterial Occlusive disease  0/254 (0.00%)  0 1/258 (0.39%)  1
Thrombophlebitis Superficial  1/254 (0.39%)  1 0/258 (0.00%)  0
1
Term from vocabulary, MedDRA (13.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FOSAVANCE 5600 Referred-Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   61/254 (24.02%)      70/258 (27.13%)    
Gastrointestinal disorders     
Diarrhoea  8/254 (3.15%)  9 13/258 (5.04%)  14
Infections and infestations     
Urinary Tract Infection  12/254 (4.72%)  12 14/258 (5.43%)  18
Injury, poisoning and procedural complications     
Contusion  13/254 (5.12%)  21 14/258 (5.43%)  19
Musculoskeletal and connective tissue disorders     
Arthralgia  20/254 (7.87%)  24 21/258 (8.14%)  23
Back Pain  12/254 (4.72%)  14 21/258 (8.14%)  22
Nervous system disorders     
Dizziness  9/254 (3.54%)  10 13/258 (5.04%)  17
1
Term from vocabulary, MedDRA (13.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00692913     History of Changes
Other Study ID Numbers: 0217A-262
2007_653
First Submitted: June 4, 2008
First Posted: June 6, 2008
Results First Submitted: July 20, 2011
Results First Posted: August 15, 2011
Last Update Posted: March 21, 2017