Trial Outcomes & Findings for Sequential Treatment of Postmenopausal Women With Primary Osteoporosis (FP-001-IM) (NCT NCT00365456)
NCT ID: NCT00365456
Last Updated: 2012-08-20
Results Overview
BMD was measured by Dual X-ray Absorptiometry (DXA).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
407 participants
Primary outcome timeframe
12 months
Results posted on
2012-08-20
Participant Flow
The trial was divided into 3 consecutive open-label treatment phases of 12 months with randomisation after Trial Period II. From 407 enrolled patients in total, 2 patients were enrolled but were never exposed to trial treatment. Thus, 405 patients in total received trial treatment.
* Period I: total number of 405 patients were included and all received PTH(1-84) treatment for 1 year * Period II: of those 405 patients, 282 continued into the 2. year and all received risedronate * Period III: during the 3. year, the remaining 268 patients were randomised to either PTH(1-84) (=136 patients) or risedronate (=132 patients)
Participant milestones
| Measure |
PTH (1-84)
|
Risedronate
|
|---|---|---|
|
Trial Period I (12 Months)
STARTED
|
407
|
0
|
|
Trial Period I (12 Months)
COMPLETED
|
282
|
0
|
|
Trial Period I (12 Months)
NOT COMPLETED
|
125
|
0
|
|
Trial Period II (12 Months)
STARTED
|
0
|
282
|
|
Trial Period II (12 Months)
COMPLETED
|
0
|
268
|
|
Trial Period II (12 Months)
NOT COMPLETED
|
0
|
14
|
|
Trial Period III (12 Months)
STARTED
|
136
|
132
|
|
Trial Period III (12 Months)
COMPLETED
|
118
|
127
|
|
Trial Period III (12 Months)
NOT COMPLETED
|
18
|
5
|
Reasons for withdrawal
| Measure |
PTH (1-84)
|
Risedronate
|
|---|---|---|
|
Trial Period I (12 Months)
Adverse Event
|
84
|
0
|
|
Trial Period I (12 Months)
Non-compliance
|
3
|
0
|
|
Trial Period I (12 Months)
Withdrawal by Subject
|
27
|
0
|
|
Trial Period I (12 Months)
Other
|
11
|
0
|
|
Trial Period II (12 Months)
Adverse Event
|
0
|
6
|
|
Trial Period II (12 Months)
Non-compliance
|
0
|
2
|
|
Trial Period II (12 Months)
Withdrawal by Subject
|
0
|
5
|
|
Trial Period II (12 Months)
Other
|
0
|
1
|
|
Trial Period III (12 Months)
Adverse Event
|
13
|
3
|
|
Trial Period III (12 Months)
Withdrawal by Subject
|
4
|
1
|
|
Trial Period III (12 Months)
Other
|
1
|
1
|
Baseline Characteristics
Sequential Treatment of Postmenopausal Women With Primary Osteoporosis (FP-001-IM)
Baseline characteristics by cohort
| Measure |
PTH(1-84) or Risedronate
n=405 Participants
* PTH(1-84) received by 405 participants in Trial Period I
* of those 405 participants, 282 received Risedronate in Trial Period II
* of those 282 participants, 268 participant remained and 136 received PTH(1-84) and 132 received Risedronate in Trial Period III
|
|---|---|
|
Age, Customized
Trial Period I / PTH(1-84)
|
64.6 years
STANDARD_DEVIATION 7.46 • n=93 Participants
|
|
Age, Customized
Trial Period II / Risedronate
|
64.2 years
STANDARD_DEVIATION 7.43 • n=93 Participants
|
|
Age, Customized
Trial Period III / PTH(1-84)
|
63.4 years
STANDARD_DEVIATION 6.94 • n=93 Participants
|
|
Age, Customized
Trial Period III / Risedronate
|
64.7 years
STANDARD_DEVIATION 7.91 • n=93 Participants
|
|
Sex/Gender, Customized
female
|
405 participants
n=93 Participants
|
|
Lumbar spine T-score
Trial Period I / PTH(1-84)
|
-3.61 score
STANDARD_DEVIATION 0.490 • n=93 Participants
|
|
Lumbar spine T-score
Trial Period II / Risedronate
|
-3.62 score
STANDARD_DEVIATION 0.472 • n=93 Participants
|
|
Lumbar spine T-score
Trial Period III / PTH(1-84)
|
-3.60 score
STANDARD_DEVIATION 0.427 • n=93 Participants
|
|
Lumbar spine T-score
Trial Period III / Risedronate
|
-3.63 score
STANDARD_DEVIATION 0.518 • n=93 Participants
|
|
Prevalent vertebral fractures
Trial Period I / PTH(1-84)
|
105 participants
n=93 Participants
|
|
Prevalent vertebral fractures
Trial Period II / Risedronate
|
71 participants
n=93 Participants
|
|
Prevalent vertebral fractures
Trial Period III / PTH(1-84)
|
37 participants
n=93 Participants
|
|
Prevalent vertebral fractures
Trial Period III / Risedronate
|
29 participants
n=93 Participants
|
|
Prevalent non-vertebral fragility fractures
Trial Period I / PTH(1-84): hip fractures
|
9 participants
n=93 Participants
|
|
Prevalent non-vertebral fragility fractures
Trial Period II / Risedronate: hip fractures
|
5 participants
n=93 Participants
|
|
Prevalent non-vertebral fragility fractures
Trial Period III / PTH(1-84): hip fractures
|
1 participants
n=93 Participants
|
|
Prevalent non-vertebral fragility fractures
Trial Period III / Risedronate: hip fractures
|
3 participants
n=93 Participants
|
|
Prevalent non-vertebral fragility fractures
Trial Period I / PTH(1-84): wrist fractures
|
78 participants
n=93 Participants
|
|
Prevalent non-vertebral fragility fractures
Trial Period II / Risedronate: wrist fractures
|
50 participants
n=93 Participants
|
|
Prevalent non-vertebral fragility fractures
Trial Period III / PTH(1-84): wrist fractures
|
22 participants
n=93 Participants
|
|
Prevalent non-vertebral fragility fractures
Trial Period III / Risedronate: wrist fractures
|
25 participants
n=93 Participants
|
|
Prevalent non-vertebral fragility fractures
Trial Period I / PTH(1-84): others
|
93 participants
n=93 Participants
|
|
Prevalent non-vertebral fragility fractures
Trial Period II / Risedronate: others
|
59 participants
n=93 Participants
|
|
Prevalent non-vertebral fragility fractures
Trial Period III / PTH(1-84): others
|
28 participants
n=93 Participants
|
|
Prevalent non-vertebral fragility fractures
Trial Period III / Risedronate: others
|
27 participants
n=93 Participants
|
|
Weight
Trial Period I / PTH(1-84)
|
59.5 kg
STANDARD_DEVIATION 9.39 • n=93 Participants
|
|
Weight
Trial Period II / Risedronate
|
59.7 kg
STANDARD_DEVIATION 9.17 • n=93 Participants
|
|
Weight
Trial Period III / PTH(1-84)
|
59.6 kg
STANDARD_DEVIATION 8.66 • n=93 Participants
|
|
Weight
Trial Period III / Risedronate
|
59.8 kg
STANDARD_DEVIATION 9.57 • n=93 Participants
|
|
Height
Trial Period I / PTH(1-84)
|
157.4 cm
STANDARD_DEVIATION 6.40 • n=93 Participants
|
|
Height
Trial Period II / Risedronate
|
157.5 cm
STANDARD_DEVIATION 6.48 • n=93 Participants
|
|
Height
Trial Period III / PTH(1-84)
|
157.6 cm
STANDARD_DEVIATION 6.21 • n=93 Participants
|
|
Height
Trial Period III / Risedronate
|
157.4 cm
STANDARD_DEVIATION 6.86 • n=93 Participants
|
|
Serum Calcium
Trial Period I / PTH(1-84)
|
2.338 mmol/L
STANDARD_DEVIATION 0.1022 • n=93 Participants
|
|
Serum Calcium
Trial Period II / Risedronate
|
2.337 mmol/L
STANDARD_DEVIATION 0.0999 • n=93 Participants
|
|
Serum Calcium
Trial Period III / PTH(1-84)
|
2.337 mmol/L
STANDARD_DEVIATION 0.0961 • n=93 Participants
|
|
Serum Calcium
Trial Period III / Risedronate
|
2.339 mmol/L
STANDARD_DEVIATION 0.1041 • n=93 Participants
|
|
Body Mass Index
Trial Period I / PTH(1-84)
|
24.06 kg/m^2
STANDARD_DEVIATION 3.861 • n=93 Participants
|
|
Body Mass Index
Trial Period II / Risedronate
|
24.11 kg/m^2
STANDARD_DEVIATION 3.788 • n=93 Participants
|
|
Body Mass Index
Trial Period III / PTH(1-84)
|
24.06 kg/m^2
STANDARD_DEVIATION 3.618 • n=93 Participants
|
|
Body Mass Index
Trial Period III / Risedronate
|
24.21 kg/m^2
STANDARD_DEVIATION 3.933 • n=93 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: All randomized patients made the Full Analysis Set which was used for the primary and secondary analyses according to intention-to-treat principles. One participant excluded due to missing baseline data at trial period III entry, thus no data could be carried forward for this patient. Missing values imputed by Last Observation Carried Forward.
BMD was measured by Dual X-ray Absorptiometry (DXA).
Outcome measures
| Measure |
PTH (1-84)
n=135 Participants
Regimen 1 = PTH (1-84) → Risedronate → PTH (1-84)
|
Risedronate
n=132 Participants
Regimen 2 = PTH (1-84) → Risedronate → Risedronate
|
|---|---|---|
|
Change in Lumbar Spine BMD From Start of Trial Period III Until End of Trial Period III.
|
1.002 Percentage Change
Standard Error 1.0037
|
0.990 Percentage Change
Standard Error 1.0034
|
Adverse Events
PTH (1-84)
Serious events: 33 serious events
Other events: 365 other events
Deaths: 0 deaths
Risedronate
Serious events: 32 serious events
Other events: 95 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PTH (1-84)
n=405 participants at risk
Trial Period I SAEs and Trial Period III SAEs for subjects receiving PTH (1-84)
|
Risedronate
n=282 participants at risk
Trial Period II SAEs and Trial Period III SAEs for subjects receiving risedronate
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.25%
1/405 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.00%
0/282 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Cardiac disorders
Arrhythmia
|
0.25%
1/405 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.00%
0/282 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/405 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.71%
2/282 • Number of events 2 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/405 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.35%
1/282 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/405 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.35%
1/282 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Ear and labyrinth disorders
Vertigo
|
0.25%
1/405 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.00%
0/282 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Endocrine disorders
Goitre
|
0.25%
1/405 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.00%
0/282 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Eye disorders
Cataract
|
0.25%
1/405 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.00%
0/282 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Eye disorders
Eye disorder
|
0.25%
1/405 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.00%
0/282 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Eye disorders
Retinal detachment
|
0.25%
1/405 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.00%
0/282 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Eye disorders
Retinal vein thrombosis
|
0.00%
0/405 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.35%
1/282 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Gastrointestinal disorders
Constipation
|
0.25%
1/405 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.00%
0/282 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/405 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.35%
1/282 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
General disorders
Condition aggravated
|
0.25%
1/405 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.71%
2/282 • Number of events 2 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.25%
1/405 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.00%
0/282 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Immune system disorders
Hypersensitivity
|
0.25%
1/405 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.00%
0/282 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Infections and infestations
Diverticulitis
|
0.49%
2/405 • Number of events 2 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.00%
0/282 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Infections and infestations
Pneumonia
|
0.25%
1/405 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.35%
1/282 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/405 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.35%
1/282 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.25%
1/405 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.00%
0/282 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.25%
1/405 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.00%
0/282 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.25%
1/405 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.00%
0/282 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.25%
1/405 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.00%
0/282 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.25%
1/405 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.00%
0/282 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.25%
1/405 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.00%
0/282 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.25%
1/405 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.00%
0/282 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.25%
1/405 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.00%
0/282 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/405 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.71%
2/282 • Number of events 2 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Injury, poisoning and procedural complications
Impacted fracture
|
0.00%
0/405 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.35%
1/282 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/405 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.35%
1/282 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/405 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.71%
2/282 • Number of events 2 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.25%
1/405 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.00%
0/282 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
0.00%
0/405 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.35%
1/282 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Musculoskeletal and connective tissue disorders
Metatarsalgia
|
0.25%
1/405 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.00%
0/282 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.25%
1/405 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.00%
0/282 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/405 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.35%
1/282 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/405 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.35%
1/282 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/405 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.35%
1/282 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/405 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.35%
1/282 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/405 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.35%
1/282 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/405 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.71%
2/282 • Number of events 2 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/405 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.35%
1/282 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.25%
1/405 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.00%
0/282 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.25%
1/405 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.35%
1/282 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Essential thrombocythaemia
|
0.25%
1/405 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.00%
0/282 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric neoplasm
|
0.25%
1/405 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.00%
0/282 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.25%
1/405 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.00%
0/282 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.00%
0/405 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.35%
1/282 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma
|
0.00%
0/405 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.35%
1/282 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Nervous system disorders
Dizziness
|
0.25%
1/405 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.00%
0/282 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Nervous system disorders
Paraesthesia
|
0.25%
1/405 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.00%
0/282 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Nervous system disorders
Syncope
|
0.25%
1/405 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.35%
1/282 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.49%
2/405 • Number of events 2 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.71%
2/282 • Number of events 2 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/405 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.35%
1/282 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/405 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.35%
1/282 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.25%
1/405 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.35%
1/282 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.25%
1/405 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.00%
0/282 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.25%
1/405 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.00%
0/282 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.25%
1/405 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.00%
0/282 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Surgical and medical procedures
Bunion operation
|
0.25%
1/405 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.00%
0/282 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Surgical and medical procedures
Medical device removal
|
0.00%
0/405 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.35%
1/282 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Vascular disorders
Angiopathy
|
0.25%
1/405 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.00%
0/282 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Vascular disorders
Femoral arterial stenosis
|
0.00%
0/405 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.35%
1/282 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/405 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.35%
1/282 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Vascular disorders
Intermittent claudication
|
0.00%
0/405 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.35%
1/282 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/405 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.35%
1/282 • Number of events 1 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/405 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.35%
1/282 • Number of events 2 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
Other adverse events
| Measure |
PTH (1-84)
n=405 participants at risk
Trial Period I SAEs and Trial Period III SAEs for subjects receiving PTH (1-84)
|
Risedronate
n=282 participants at risk
Trial Period II SAEs and Trial Period III SAEs for subjects receiving risedronate
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
5.9%
24/405 • Number of events 26 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.00%
0/282 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Gastrointestinal disorders
Nausea
|
24.2%
98/405 • Number of events 123 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.00%
0/282 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
General disorders
Asthenia
|
5.7%
23/405 • Number of events 24 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.00%
0/282 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Infections and infestations
Urinary tract infection
|
5.7%
23/405 • Number of events 28 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
5.0%
14/282 • Number of events 16 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Infections and infestations
Influenza
|
0.00%
0/405 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
7.1%
20/282 • Number of events 24 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
21.5%
87/405 • Number of events 105 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
6.0%
17/282 • Number of events 20 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
31/405 • Number of events 32 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
5.3%
15/282 • Number of events 15 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/405 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
5.0%
14/282 • Number of events 16 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/405 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
5.3%
15/282 • Number of events 16 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Nervous system disorders
Headache
|
8.6%
35/405 • Number of events 40 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.00%
0/282 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
|
Renal and urinary disorders
Hypercalciuria
|
29.9%
121/405 • Number of events 150 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
0.00%
0/282 • Over three years of the trial duration.
The safety analysis set (SAF) was defined as all subjects enrolled in Trial Period I who received at least one dose of the IMP. At each contact between the site and the subject (visit or phone) the subject was asked if she has experienced any health problems since the last contact.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After publication of the results or 24 months after Clinical Trial Report has been finalised, whichever comes first, Nycomed acknowledge the Investigator's rights to publish results from this trial. Any such scientific paper, presentation, communication, or other information concerning the investigation described in this protocol, must be submitted to Nycomed prior to submission for publication/presentation for review. Review comments will be given within a month from receipt of the manuscript.
- Publication restrictions are in place
Restriction type: OTHER