Trial Outcomes & Findings for A Study to Test the Effect of MK0217A on Vitamin D Inadequacy in Postmenopausal Women With Osteoporosis (0217A-262) (NCT NCT00692913)
NCT ID: NCT00692913
Last Updated: 2024-05-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
515 participants
Primary outcome timeframe
Week 26
Results posted on
2024-05-09
Participant Flow
Participant milestones
| Measure |
FOSAVANCE 5600
Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
|
Referred-Care
Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
|
|---|---|---|
|
Overall Study
STARTED
|
257
|
258
|
|
Overall Study
COMPLETED
|
228
|
228
|
|
Overall Study
NOT COMPLETED
|
29
|
30
|
Reasons for withdrawal
| Measure |
FOSAVANCE 5600
Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
|
Referred-Care
Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
|
|---|---|---|
|
Overall Study
Adverse Event
|
8
|
4
|
|
Overall Study
Lost to Follow-up
|
3
|
5
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
15
|
20
|
Baseline Characteristics
A Study to Test the Effect of MK0217A on Vitamin D Inadequacy in Postmenopausal Women With Osteoporosis (0217A-262)
Baseline characteristics by cohort
| Measure |
FOSAVANCE 5600
n=257 Participants
Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
|
Referred-Care
n=258 Participants
Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
|
Total
n=515 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.9 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
72.9 years
STANDARD_DEVIATION 5.9 • n=7 Participants
|
72.9 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
257 Participants
n=5 Participants
|
258 Participants
n=7 Participants
|
515 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 26Population: 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.
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.
Outcome measures
| Measure |
FOSAVANCE 5600
n=221 Participants
Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
|
Referred-Care
n=216 Participants
Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
|
|---|---|---|
|
Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 26
|
8.6 Percentage of Participants
|
31.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 26Population: Per-Protocol Population: excluded participants due to important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.
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.
Outcome measures
| Measure |
FOSAVANCE 5600
n=216 Participants
Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
|
Referred-Care
n=226 Participants
Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
|
|---|---|---|
|
Percent Change From Baseline at Week 26 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio
|
-57.06 Percent Change
Interval -60.19 to -53.68
|
-47.36 Percent Change
Interval -51.23 to -43.18
|
SECONDARY outcome
Timeframe: Baseline and Week 26Population: Per-Protocol Population: excluded participants due to important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.
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.
Outcome measures
| Measure |
FOSAVANCE 5600
n=223 Participants
Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
|
Referred-Care
n=237 Participants
Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
|
|---|---|---|
|
Percent Change From Baseline at Week 26 in Bone-Specific Alkaline Phosphatase
|
-46.67 Percent Change
Interval -49.32 to -43.88
|
-39.60 Percent Change
Interval -42.6 to -36.44
|
SECONDARY outcome
Timeframe: Week 52Population: 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.
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.
Outcome measures
| Measure |
FOSAVANCE 5600
n=212 Participants
Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
|
Referred-Care
n=203 Participants
Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
|
|---|---|---|
|
Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 52
|
11.3 Percentage of Participants
|
36.9 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: 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.
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.
Outcome measures
| Measure |
FOSAVANCE 5600
n=227 Participants
Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
|
Referred-Care
n=219 Participants
Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
|
|---|---|---|
|
Percent Change From Baseline in Lumbar Spine and Total Hip Bone Mineral Density
Lumbar Spine (n= 226/ n=219)
|
4.92 Percent Change
Interval 4.17 to 5.66
|
3.91 Percent Change
Interval 3.16 to 4.66
|
|
Percent Change From Baseline in Lumbar Spine and Total Hip Bone Mineral Density
Total Hip (n=227/ n=218)
|
2.22 Percent Change
Interval 1.65 to 2.79
|
1.40 Percent Change
Interval 0.83 to 1.97
|
SECONDARY outcome
Timeframe: Up to Week 52Population: 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.
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.
Outcome measures
| Measure |
FOSAVANCE 5600
n=257 Participants
Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
|
Referred-Care
n=258 Participants
Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
|
|---|---|---|
|
Falls Per Participant
|
0.51 Number of Falls
Standard Deviation 1.53
|
0.45 Number of Falls
Standard Deviation 0.80
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Per-Protocol Population: excluded patients due to important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.
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.
Outcome measures
| Measure |
FOSAVANCE 5600
n=216 Participants
Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
|
Referred-Care
n=227 Participants
Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
|
|---|---|---|
|
Percent Change From Baseline at Week 52 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio
|
-58.42 Percent Change
Interval -61.58 to -54.99
|
-50.07 Percent Change
Interval -54.01 to -45.79
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Per-Protocol Population: excluded patients due to important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.
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.
Outcome measures
| Measure |
FOSAVANCE 5600
n=223 Participants
Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
|
Referred-Care
n=237 Participants
Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
|
|---|---|---|
|
Percent Change From Baseline at Week 52 in Bone-Specific Alkaline Phosphatase
|
-51.21 Percent Change
Interval -53.79 to -48.48
|
-43.13 Percent Change
Interval -46.18 to -39.91
|
Adverse Events
FOSAVANCE 5600
Serious events: 25 serious events
Other events: 61 other events
Deaths: 0 deaths
Referred-Care
Serious events: 29 serious events
Other events: 70 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FOSAVANCE 5600
n=254 participants at risk
Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
|
Referred-Care
n=258 participants at risk
Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
|
|---|---|---|
|
Nervous system disorders
Vascular Dementia
|
0.00%
0/254
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.
|
0.39%
1/258 • Number of events 1
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.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/254
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.
|
0.39%
1/258 • Number of events 1
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.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/254
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.
|
0.39%
1/258 • Number of events 1
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.
|
|
Renal and urinary disorders
Renal Artery Stenosis
|
0.00%
0/254
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.
|
0.39%
1/258 • Number of events 1
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.
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.39%
1/254 • Number of events 1
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.
|
0.00%
0/258
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.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.39%
1/254 • Number of events 1
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.
|
0.00%
0/258
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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.39%
1/254 • Number of events 2
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.
|
0.00%
0/258
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Congestion
|
0.39%
1/254 • Number of events 1
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.
|
0.00%
0/258
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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.39%
1/254 • Number of events 1
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.
|
0.00%
0/258
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.
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/254
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.
|
0.39%
1/258 • Number of events 1
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.
|
|
Vascular disorders
Peripheral Arterial Occlusive disease
|
0.00%
0/254
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.
|
0.39%
1/258 • Number of events 1
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.
|
|
Vascular disorders
Thrombophlebitis Superficial
|
0.39%
1/254 • Number of events 1
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.
|
0.00%
0/258
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.
|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/254
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.
|
0.39%
1/258 • Number of events 1
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.
|
|
Cardiac disorders
Atrial Fibrillation
|
1.2%
3/254 • Number of events 3
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.
|
0.39%
1/258 • Number of events 2
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.
|
|
Cardiac disorders
Cardiac Failure
|
0.39%
1/254 • Number of events 1
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.
|
0.00%
0/258
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.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.79%
2/254 • Number of events 2
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.
|
0.00%
0/258
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.
|
|
Cardiac disorders
Electromechanical Dissociation
|
0.39%
1/254 • Number of events 1
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.
|
0.00%
0/258
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.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/254
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.
|
0.39%
1/258 • Number of events 1
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.
|
|
Cardiac disorders
Sick Sinus Syndrome
|
0.39%
1/254 • Number of events 1
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.
|
0.00%
0/258
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.
|
|
Eye disorders
Eye Haemorrhage
|
0.00%
0/254
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.
|
0.39%
1/258 • Number of events 1
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.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/254
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.
|
0.39%
1/258 • Number of events 1
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.39%
1/254 • Number of events 1
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.
|
0.00%
0/258
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.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/254
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.
|
0.39%
1/258 • Number of events 1
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.
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.39%
1/254 • Number of events 1
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.
|
0.00%
0/258
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.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
0.39%
1/254 • Number of events 1
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.
|
0.00%
0/258
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.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/254
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.
|
0.39%
1/258 • Number of events 1
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.
|
|
Gastrointestinal disorders
Retroperitoneal Haemorrhage
|
0.39%
1/254 • Number of events 1
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.
|
0.00%
0/258
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.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/254
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.
|
0.39%
1/258 • Number of events 1
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.
|
|
General disorders
Chest Pain
|
0.39%
1/254 • Number of events 1
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.
|
0.00%
0/258
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.
|
|
General disorders
Local Swelling
|
0.00%
0/254
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.
|
0.39%
1/258 • Number of events 1
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.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.39%
1/254 • Number of events 1
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.
|
0.39%
1/258 • Number of events 1
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.
|
|
General disorders
Pyrexia
|
0.39%
1/254 • Number of events 1
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.
|
0.00%
0/258
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.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/254
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.
|
0.39%
1/258 • Number of events 1
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.
|
|
Infections and infestations
Bacterial Diarrhoea
|
0.00%
0/254
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.
|
0.39%
1/258 • Number of events 1
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.
|
|
Infections and infestations
Bronchitis
|
0.39%
1/254 • Number of events 1
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.
|
0.00%
0/258
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.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/254
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.
|
0.39%
1/258 • Number of events 1
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.
|
|
Infections and infestations
Enterovirus Infection
|
0.00%
0/254
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.
|
0.39%
1/258 • Number of events 1
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.
|
|
Infections and infestations
Gastroenteritis Viral
|
0.39%
1/254 • Number of events 1
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.
|
0.00%
0/258
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.
|
|
Infections and infestations
Malaria
|
0.39%
1/254 • Number of events 1
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.
|
0.00%
0/258
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.
|
|
Infections and infestations
Peritonsillar Abscess
|
0.39%
1/254 • Number of events 1
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.
|
0.00%
0/258
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.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/254
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.
|
0.39%
1/258 • Number of events 1
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.
|
|
Infections and infestations
Sepsis
|
0.39%
1/254 • Number of events 1
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.
|
0.00%
0/258
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.
|
|
Infections and infestations
Subacute Endocarditis
|
0.39%
1/254 • Number of events 1
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.
|
0.00%
0/258
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.
|
|
Infections and infestations
Urinary Tract Infection
|
0.39%
1/254 • Number of events 1
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.
|
0.00%
0/258
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.
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.39%
1/254 • Number of events 1
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.
|
0.00%
0/258
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.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/254
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.
|
0.78%
2/258 • Number of events 2
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.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/254
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.
|
0.78%
2/258 • Number of events 2
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.
|
|
Injury, poisoning and procedural complications
Meniscus Lesion
|
0.00%
0/254
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.
|
0.39%
1/258 • Number of events 1
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.
|
|
Injury, poisoning and procedural complications
Pubis Fracture
|
0.00%
0/254
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.
|
0.39%
1/258 • Number of events 1
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.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/254
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.
|
0.39%
1/258 • Number of events 1
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.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.39%
1/254 • Number of events 1
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.
|
0.39%
1/258 • Number of events 1
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.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/254
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.
|
0.39%
1/258 • Number of events 1
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.
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
0.00%
0/254
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.
|
0.39%
1/258 • Number of events 1
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.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/254
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.
|
0.39%
1/258 • Number of events 1
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.
|
|
Musculoskeletal and connective tissue disorders
Spinal Column Stenosis
|
0.39%
1/254 • Number of events 1
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.
|
0.39%
1/258 • Number of events 1
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.39%
1/254 • Number of events 1
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.
|
0.78%
2/258 • Number of events 3
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.00%
0/254
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.
|
0.39%
1/258 • Number of events 1
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal Squamous Cell Carcinoma
|
0.39%
1/254 • Number of events 1
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.
|
0.00%
0/258
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Epithelial Cancer
|
0.39%
1/254 • Number of events 1
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.
|
0.00%
0/258
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma
|
0.39%
1/254 • Number of events 1
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.
|
0.00%
0/258
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Cancer
|
0.39%
1/254 • Number of events 1
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.
|
0.00%
0/258
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.
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.00%
0/254
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.
|
0.39%
1/258 • Number of events 1
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.
|
|
Nervous system disorders
Cerebral Ischaemia
|
0.39%
1/254 • Number of events 1
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.
|
0.00%
0/258
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.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.39%
1/254 • Number of events 1
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.
|
0.00%
0/258
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.
|
|
Nervous system disorders
Facial Palsy
|
0.00%
0/254
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.
|
0.39%
1/258 • Number of events 1
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.
|
|
Nervous system disorders
Radiculopathy
|
0.39%
1/254 • Number of events 1
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.
|
0.00%
0/258
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.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/254
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.
|
0.39%
1/258 • Number of events 1
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.
|
|
Nervous system disorders
Unresponsive to Stimuli
|
0.39%
1/254 • Number of events 1
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.
|
0.00%
0/258
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.
|
Other adverse events
| Measure |
FOSAVANCE 5600
n=254 participants at risk
Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
|
Referred-Care
n=258 participants at risk
Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
3.1%
8/254 • Number of events 9
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.
|
5.0%
13/258 • Number of events 14
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.
|
|
Infections and infestations
Urinary Tract Infection
|
4.7%
12/254 • Number of events 12
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.
|
5.4%
14/258 • Number of events 18
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.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.1%
13/254 • Number of events 21
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.
|
5.4%
14/258 • Number of events 19
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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.9%
20/254 • Number of events 24
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.
|
8.1%
21/258 • Number of events 23
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.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
4.7%
12/254 • Number of events 14
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.
|
8.1%
21/258 • Number of events 22
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.
|
|
Nervous system disorders
Dizziness
|
3.5%
9/254 • Number of events 10
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.
|
5.0%
13/258 • Number of events 17
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.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER