Trial Outcomes & Findings for Efficacy and Safety Study of Risedronate, Cholecalciferol Combination Tablet in Patients With Osteoporosis (NCT NCT01675297)
NCT ID: NCT01675297
Last Updated: 2019-08-05
Results Overview
Higher Bone Mineral Density(BMD) value mean a better outcome.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1053 participants
Primary outcome timeframe
baseline and 12 months
Results posted on
2019-08-05
Participant Flow
medical clinic
wash out 7\~14days
Participant milestones
| Measure |
Risendronate/Cholecalciferol Combination
Experimental: Administer Risendronate/Cholecalciferol combination one tablet once a week for 12months.
Risedronate/Cholecalciferol combination: once a week
|
Risedronate
Active comparator: Administer Risendronate one tablet once a week for 12months.
Risedronate: once a week
|
|---|---|---|
|
Overall Study
STARTED
|
806
|
247
|
|
Overall Study
COMPLETED
|
642
|
199
|
|
Overall Study
NOT COMPLETED
|
164
|
48
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety Study of Risedronate, Cholecalciferol Combination Tablet in Patients With Osteoporosis
Baseline characteristics by cohort
| Measure |
Risendronate/Cholecalciferol Combination
n=806 Participants
Risendronate/Cholecalciferol combination Risenex Plus tablet: one tablet once a week for 12months
Risedronate/Cholecalciferol combination: Risendronate/Cholecalciferol combination once a week
|
Risedronate
n=247 Participants
Sedron tablet: one tablet once a week for 12months
Risedronate: Risedronate once a week
|
Total
n=1053 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.77 years
STANDARD_DEVIATION 7.87 • n=5 Participants
|
65.51 years
STANDARD_DEVIATION 8.59 • n=7 Participants
|
65.71 years
STANDARD_DEVIATION 8.04 • n=5 Participants
|
|
Sex: Female, Male
Female
|
754 Participants
n=5 Participants
|
236 Participants
n=7 Participants
|
990 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
23.40 kg/m^2
STANDARD_DEVIATION 3.32 • n=5 Participants
|
23.00 kg/m^2
STANDARD_DEVIATION 3.00 • n=7 Participants
|
23.31 kg/m^2
STANDARD_DEVIATION 3.25 • n=5 Participants
|
|
Osteoporosis disease period
|
23.90 years
STANDARD_DEVIATION 37.49 • n=5 Participants
|
27.07 years
STANDARD_DEVIATION 40.44 • n=7 Participants
|
24.65 years
STANDARD_DEVIATION 38.21 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 12 monthsHigher Bone Mineral Density(BMD) value mean a better outcome.
Outcome measures
| Measure |
Risendronate/Cholecalciferol Combination
n=642 Participants
Experimental: Administer Risendronate/Cholecalciferol combination one tablet once a week for 12months.
Risedronate/Cholecalciferol combination: once a week
|
Risedronate
n=199 Participants
Active comparator: Administer Risendronate one tablet once a week for 12months.
Risedronate: once a week
|
|---|---|---|
|
The Change of Bone Mineral Density (BMD) Value
baseline
|
0.77 g/cm^2
Standard Deviation 0.11
|
0.77 g/cm^2
Standard Deviation 0.10
|
|
The Change of Bone Mineral Density (BMD) Value
12 months
|
0.81 g/cm^2
Standard Deviation 0.12
|
0.80 g/cm^2
Standard Deviation 0.11
|
|
The Change of Bone Mineral Density (BMD) Value
change(12months-baseline)
|
0.04 g/cm^2
Standard Deviation 0.05
|
0.03 g/cm^2
Standard Deviation 0.04
|
SECONDARY outcome
Timeframe: baseline, 6months, 12monthsrange of 25OHD: 4.80\~52.80 Higher 25OHD scores mean a better outcome. If there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed.
Outcome measures
| Measure |
Risendronate/Cholecalciferol Combination
n=642 Participants
Experimental: Administer Risendronate/Cholecalciferol combination one tablet once a week for 12months.
Risedronate/Cholecalciferol combination: once a week
|
Risedronate
n=199 Participants
Active comparator: Administer Risendronate one tablet once a week for 12months.
Risedronate: once a week
|
|---|---|---|
|
The Change of 25OHD(25-hydroxyvitamin D)
25OHD(baseline)
|
18.23 ng/ml
Standard Deviation 11.59
|
17.83 ng/ml
Standard Deviation 10.99
|
|
The Change of 25OHD(25-hydroxyvitamin D)
25OHD change(12months-baseline)
|
12.33 ng/ml
Standard Deviation 13.33
|
0.53 ng/ml
Standard Deviation 12.74
|
|
The Change of 25OHD(25-hydroxyvitamin D)
25OHD(6months)
|
28.93 ng/ml
Standard Deviation 11.16
|
19.47 ng/ml
Standard Deviation 12.53
|
|
The Change of 25OHD(25-hydroxyvitamin D)
25OHD(12months)
|
30.57 ng/ml
Standard Deviation 11.89
|
18.35 ng/ml
Standard Deviation 11.73
|
|
The Change of 25OHD(25-hydroxyvitamin D)
25OHD change(6months-baseline)
|
10.74 ng/ml
Standard Deviation 11.53
|
1.68 ng/ml
Standard Deviation 9.47
|
SECONDARY outcome
Timeframe: baseline, 6months, 12monthsrange of PTH: 13\~54 Higher PTH scores mean a worse outcome. If there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed.
Outcome measures
| Measure |
Risendronate/Cholecalciferol Combination
n=642 Participants
Experimental: Administer Risendronate/Cholecalciferol combination one tablet once a week for 12months.
Risedronate/Cholecalciferol combination: once a week
|
Risedronate
n=199 Participants
Active comparator: Administer Risendronate one tablet once a week for 12months.
Risedronate: once a week
|
|---|---|---|
|
PTH(Parathyroid Hormone Value)
PTH(baseline)
|
40.48 pg/ml
Standard Deviation 30.95
|
39.17 pg/ml
Standard Deviation 34.04
|
|
PTH(Parathyroid Hormone Value)
PTH(6months)
|
37.34 pg/ml
Standard Deviation 23.82
|
42.40 pg/ml
Standard Deviation 27.79
|
|
PTH(Parathyroid Hormone Value)
PTH(12months)
|
39.17 pg/ml
Standard Deviation 19.37
|
45.27 pg/ml
Standard Deviation 23.68
|
|
PTH(Parathyroid Hormone Value)
PTH change(6months-baseline)
|
-2.78 pg/ml
Standard Deviation 23.36
|
3.39 pg/ml
Standard Deviation 35.57
|
|
PTH(Parathyroid Hormone Value)
PTH change(12months-baseline)
|
-1.34 pg/ml
Standard Deviation 27.31
|
6.16 pg/ml
Standard Deviation 33.33
|
Adverse Events
Risendronate/Cholecalciferol Combination
Serious events: 61 serious events
Other events: 61 other events
Deaths: 9 deaths
Risedronate
Serious events: 19 serious events
Other events: 29 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Risendronate/Cholecalciferol Combination
n=806 participants at risk
Experimental: Administer Risendronate/Cholecalciferol combination one tablet once a week for 12months.
Risedronate/Cholecalciferol combination: once a week
|
Risedronate
n=247 participants at risk
Active comparator: Administer Risendronate one tablet once a week for 12months.
Risedronate: once a week
|
|---|---|---|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.25%
2/806 • Number of events 2 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.81%
2/247 • Number of events 2 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.37%
3/806 • Number of events 3 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.00%
0/247 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.37%
3/806 • Number of events 3 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.00%
0/247 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.37%
3/806 • Number of events 3 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.00%
0/247 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.25%
2/806 • Number of events 2 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.81%
2/247 • Number of events 2 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.12%
1/806 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.40%
1/247 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.25%
2/806 • Number of events 2 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.00%
0/247 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/806 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.40%
1/247 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.12%
1/806 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.00%
0/247 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/806 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.40%
1/247 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.12%
1/806 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.00%
0/247 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/806 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.40%
1/247 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.12%
1/806 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.00%
0/247 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.12%
1/806 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.00%
0/247 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.12%
1/806 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.00%
0/247 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.12%
1/806 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.00%
0/247 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.12%
1/806 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.00%
0/247 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.12%
1/806 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.40%
1/247 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.12%
1/806 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.40%
1/247 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.12%
1/806 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.40%
1/247 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/806 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.40%
1/247 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.12%
1/806 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.00%
0/247 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/806 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.40%
1/247 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/806 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.40%
1/247 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Musculoskeletal and connective tissue disorders
Still's disease adult onset
|
0.12%
1/806 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.00%
0/247 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Infections and infestations
Chronic sinusitis
|
0.25%
2/806 • Number of events 2 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.00%
0/247 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Infections and infestations
Pyelonephritis acute
|
0.25%
2/806 • Number of events 2 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.00%
0/247 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Infections and infestations
Bronchitis
|
0.12%
1/806 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.00%
0/247 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/806 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.40%
1/247 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Infections and infestations
Infectious pleural effusion
|
0.12%
1/806 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.00%
0/247 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Infections and infestations
Pneumonia
|
0.12%
1/806 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.00%
0/247 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.12%
1/806 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.00%
0/247 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/806 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.40%
1/247 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer stage IV
|
0.12%
1/806 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.00%
0/247 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.12%
1/806 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.00%
0/247 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pyogenic granuloma
|
0.12%
1/806 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.00%
0/247 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.12%
1/806 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.00%
0/247 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.12%
1/806 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.00%
0/247 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.00%
0/806 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.40%
1/247 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.25%
2/806 • Number of events 2 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.00%
0/247 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.25%
2/806 • Number of events 2 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.00%
0/247 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/806 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.40%
1/247 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.12%
1/806 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.00%
0/247 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.12%
1/806 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.00%
0/247 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.25%
2/806 • Number of events 2 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.00%
0/247 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Nervous system disorders
Brain oedema
|
0.12%
1/806 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.00%
0/247 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.12%
1/806 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.00%
0/247 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Nervous system disorders
Cerebral infarction
|
0.12%
1/806 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.00%
0/247 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Nervous system disorders
Hydrocephalus
|
0.12%
1/806 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.00%
0/247 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Gastrointestinal disorders
Constipation
|
0.12%
1/806 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.00%
0/247 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Gastrointestinal disorders
Distal intestinal obstruction syndrome
|
0.12%
1/806 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.00%
0/247 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.12%
1/806 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.00%
0/247 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.12%
1/806 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.00%
0/247 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.12%
1/806 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.00%
0/247 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Cardiac disorders
Prinzmetal angina
|
0.12%
1/806 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.00%
0/247 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.12%
1/806 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.00%
0/247 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.12%
1/806 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.00%
0/247 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Social circumstances
Elderly
|
0.12%
1/806 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.40%
1/247 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Eye disorders
Cataract
|
0.00%
0/806 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.40%
1/247 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
General disorders
Asthenia
|
0.00%
0/806 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.40%
1/247 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.12%
1/806 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.00%
0/247 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Psychiatric disorders
Completed suicide
|
0.12%
1/806 • Number of events 1 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
0.00%
0/247 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
Other adverse events
| Measure |
Risendronate/Cholecalciferol Combination
n=806 participants at risk
Experimental: Administer Risendronate/Cholecalciferol combination one tablet once a week for 12months.
Risedronate/Cholecalciferol combination: once a week
|
Risedronate
n=247 participants at risk
Active comparator: Administer Risendronate one tablet once a week for 12months.
Risedronate: once a week
|
|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
2.5%
20/806 • Number of events 21 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
4.5%
11/247 • Number of events 11 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.5%
12/806 • Number of events 14 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
2.0%
5/247 • Number of events 7 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
10/806 • Number of events 10 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
2.0%
5/247 • Number of events 5 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
|
Infections and infestations
Nasopharyngitis
|
2.4%
19/806 • Number of events 22 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
3.2%
8/247 • Number of events 9 • 12months
The safety evaluation was conducted in the safety set(Risendronate/Cholecalciferol Combination: 806, Risendronate: 247) Safety set means exclude do not administering investigational product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place