Trial Outcomes & Findings for Assessment of Efficacy of Zoledronic Acid in the Treatment of Bone Marrow Edema Syndrome (NCT NCT01348269)
NCT ID: NCT01348269
Last Updated: 2024-08-13
Results Overview
The volume of the edema in cm³ is defined as biometric data measured by the use of MRI before and six weeks after treatment. Edema volume at screening was set to 100%. Edema volume six weeks after study drug administration was provdied as percentage reduction compared to the value at screening
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
48 participants
Primary outcome timeframe
Week 6 after administration of a single intravenous dose of zoledronic acid (5 mg)
Results posted on
2024-08-13
Participant Flow
Participant milestones
| Measure |
Zoledronic Acid
single-dose zoledronic acid (Aclasta) with vitamin D 1000IU/d - 5 mg i.v.
|
Placebo
placebo with vitamin D 1000 IU/d (NaCl Solution)
|
|---|---|---|
|
Baseline
STARTED
|
34
|
14
|
|
Baseline
COMPLETED
|
34
|
14
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
|
Treatment | Core Study (Until Week 6)
STARTED
|
34
|
14
|
|
Treatment | Core Study (Until Week 6)
COMPLETED
|
34
|
14
|
|
Treatment | Core Study (Until Week 6)
NOT COMPLETED
|
0
|
0
|
|
Follow-up (Until Week 12)
STARTED
|
34
|
14
|
|
Follow-up (Until Week 12)
COMPLETED
|
32
|
13
|
|
Follow-up (Until Week 12)
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Zoledronic Acid
single-dose zoledronic acid (Aclasta) with vitamin D 1000IU/d - 5 mg i.v.
|
Placebo
placebo with vitamin D 1000 IU/d (NaCl Solution)
|
|---|---|---|
|
Follow-up (Until Week 12)
Surgical intervention - not study related
|
1
|
0
|
|
Follow-up (Until Week 12)
Subsequent follow-up treatment required
|
0
|
1
|
|
Follow-up (Until Week 12)
Adverse Event
|
1
|
0
|
Baseline Characteristics
Assessment of Efficacy of Zoledronic Acid in the Treatment of Bone Marrow Edema Syndrome
Baseline characteristics by cohort
| Measure |
Zoledronic Acid
n=34 Participants
single-dose zoledronic acid (Aclasta) with vitamin D 1000IU/d - 5 mg i.v.
|
Placebo
n=14 Participants
placebo with vitamin D 1000 IU/d (NaCl Solution)
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Severity of disease
mild
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Severity of disease
moderate
|
22 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Severity of disease
severe
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Pain (VAS)
|
36.9 units on a scale
STANDARD_DEVIATION 27.4 • n=5 Participants
|
34.1 units on a scale
STANDARD_DEVIATION 21.1 • n=7 Participants
|
34.9 units on a scale
STANDARD_DEVIATION 24.8 • n=5 Participants
|
|
Qualeffo-41
|
2.1 units on a scale
STANDARD_DEVIATION 0.5 • n=5 Participants
|
2.2 units on a scale
STANDARD_DEVIATION 0.6 • n=7 Participants
|
2.1 units on a scale
STANDARD_DEVIATION 0.5 • n=5 Participants
|
|
Subjective estimation of medical condition (Paian Disability Index)
|
20.8 units on a scale
STANDARD_DEVIATION 6.8 • n=5 Participants
|
21.3 units on a scale
STANDARD_DEVIATION 6.4 • n=7 Participants
|
20.8 units on a scale
STANDARD_DEVIATION 13.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 6 after administration of a single intravenous dose of zoledronic acid (5 mg)The volume of the edema in cm³ is defined as biometric data measured by the use of MRI before and six weeks after treatment. Edema volume at screening was set to 100%. Edema volume six weeks after study drug administration was provdied as percentage reduction compared to the value at screening
Outcome measures
| Measure |
Zoledronic Acid
n=34 Participants
single-dose zoledronic acid (Aclasta) with vitamin D 1000IU/d - 5 mg i.v.
|
Placebo
n=13 Participants
placebo with vitamin D 1000 IU/d (NaCl Solution)
|
|---|---|---|
|
Reduction of the Edema Area
|
64.53 percentage of edema volume
Standard Deviation 41.92
|
23.97 percentage of edema volume
Standard Deviation 46.52
|
SECONDARY outcome
Timeframe: Assessment at week 3Population: Reporting group
Reduction of pain as measured by a Visual Analog Scale (VAS). Range 0-100 with higher values indicating worse pain.
Outcome measures
| Measure |
Zoledronic Acid
n=34 Participants
single-dose zoledronic acid (Aclasta) with vitamin D 1000IU/d - 5 mg i.v.
|
Placebo
n=14 Participants
placebo with vitamin D 1000 IU/d (NaCl Solution)
|
|---|---|---|
|
Reduction of Pain (VAS)
|
25.5 units on a scale
Standard Deviation 22.7
|
25.6 units on a scale
Standard Deviation 24.4
|
SECONDARY outcome
Timeframe: Assessment at week 6Population: Reporting group
Reduction of pain as measured by a visual analog scale (VAS). Range 0-100. Higher values indicating worse pain.
Outcome measures
| Measure |
Zoledronic Acid
n=34 Participants
single-dose zoledronic acid (Aclasta) with vitamin D 1000IU/d - 5 mg i.v.
|
Placebo
n=14 Participants
placebo with vitamin D 1000 IU/d (NaCl Solution)
|
|---|---|---|
|
Reduction of Pain
|
25.0 units on a scale
Standard Deviation 28.7
|
38.5 units on a scale
Standard Deviation 30.2
|
SECONDARY outcome
Timeframe: Assessment at week 3Population: Reporting group
Quality of life as measured by the Qualeffo-41 questionnaire - a quality of life questionnaire in patients with fractures of the European Foundation for Osteoporosis Higher values indicate worse quality of life
Outcome measures
| Measure |
Zoledronic Acid
n=34 Participants
single-dose zoledronic acid (Aclasta) with vitamin D 1000IU/d - 5 mg i.v.
|
Placebo
n=14 Participants
placebo with vitamin D 1000 IU/d (NaCl Solution)
|
|---|---|---|
|
Quality of Life (Qualeffo-41 Questionnaire)
|
2.1 units on a scale
Standard Deviation 0.4
|
2.1 units on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Assessment at week 6Population: Reporting group
Quality of life as measured by the Qualeffo-41 questionnaire - a quality of life questionnaire in patients with vertebral fractures of the European Foundation for Osteoporosis
Outcome measures
| Measure |
Zoledronic Acid
n=34 Participants
single-dose zoledronic acid (Aclasta) with vitamin D 1000IU/d - 5 mg i.v.
|
Placebo
n=14 Participants
placebo with vitamin D 1000 IU/d (NaCl Solution)
|
|---|---|---|
|
Quality of Life (Qualeffo-41 Questionnaire)
|
2.0 units on a scale
Standard Deviation 0.5
|
2.1 units on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Assessment at week 3Population: Reporting group
Subjective estimation of medical condition as assessed by PDI (Pain Disability Index). Range 0-70. The higher the index the greater the person's disability due to pain.
Outcome measures
| Measure |
Zoledronic Acid
n=34 Participants
single-dose zoledronic acid (Aclasta) with vitamin D 1000IU/d - 5 mg i.v.
|
Placebo
n=14 Participants
placebo with vitamin D 1000 IU/d (NaCl Solution)
|
|---|---|---|
|
Subjective Estimation of Medical Condition (PDI)
|
14.8 units on a scale
Standard Deviation 5.8
|
20.5 units on a scale
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: Assessment at week 6Population: Reporting group
Subjective estimation of medical condition as assessed by PDI (Pain Disability Index)
Outcome measures
| Measure |
Zoledronic Acid
n=34 Participants
single-dose zoledronic acid (Aclasta) with vitamin D 1000IU/d - 5 mg i.v.
|
Placebo
n=14 Participants
placebo with vitamin D 1000 IU/d (NaCl Solution)
|
|---|---|---|
|
Subjective Estimation of Medical Condition (PDI)
|
13.1 units on a scale
Standard Deviation 6.0
|
18.8 units on a scale
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: Assessment at week 3Population: Reporting group
Number of additional medicinal visits until week 3
Outcome measures
| Measure |
Zoledronic Acid
n=34 Participants
single-dose zoledronic acid (Aclasta) with vitamin D 1000IU/d - 5 mg i.v.
|
Placebo
n=14 Participants
placebo with vitamin D 1000 IU/d (NaCl Solution)
|
|---|---|---|
|
Number of Additional Medicinal Visits
|
1 Number of additional medicinal visits
|
0 Number of additional medicinal visits
|
SECONDARY outcome
Timeframe: Assessment at week 6Population: Reporting Group
Aggregated number of unscheduled medicinal visits
Outcome measures
| Measure |
Zoledronic Acid
n=34 Participants
single-dose zoledronic acid (Aclasta) with vitamin D 1000IU/d - 5 mg i.v.
|
Placebo
n=14 Participants
placebo with vitamin D 1000 IU/d (NaCl Solution)
|
|---|---|---|
|
Number of Additional Medicinal Visits
|
0 Medicinal Visits
|
0 Medicinal Visits
|
SECONDARY outcome
Timeframe: Assessment at week 6Population: Reporting group
Aggregated number of days of illness i.e. sick leave from work, assessed until week 6
Outcome measures
| Measure |
Zoledronic Acid
n=34 Participants
single-dose zoledronic acid (Aclasta) with vitamin D 1000IU/d - 5 mg i.v.
|
Placebo
n=14 Participants
placebo with vitamin D 1000 IU/d (NaCl Solution)
|
|---|---|---|
|
Number of Days of Illness
|
1.24 days
Standard Deviation 5.02
|
3.00 days
Standard Deviation 7.63
|
SECONDARY outcome
Timeframe: Assessment at week 6Population: Reporting group
Number of days of illness assessed until week 6
Outcome measures
| Measure |
Zoledronic Acid
n=34 Participants
single-dose zoledronic acid (Aclasta) with vitamin D 1000IU/d - 5 mg i.v.
|
Placebo
n=14 Participants
placebo with vitamin D 1000 IU/d (NaCl Solution)
|
|---|---|---|
|
Number of Days of Illness
|
0.94 days
Standard Deviation 4.10
|
3.14 days
Standard Deviation 4.10
|
SECONDARY outcome
Timeframe: Baseline until end of study (week 12)Population: Reporting group
Assessment of number of patients withaseptic bone necrosis and/or fatigue fractures.
Outcome measures
| Measure |
Zoledronic Acid
n=34 Participants
single-dose zoledronic acid (Aclasta) with vitamin D 1000IU/d - 5 mg i.v.
|
Placebo
n=14 Participants
placebo with vitamin D 1000 IU/d (NaCl Solution)
|
|---|---|---|
|
Number of Aseptic Bone Necrosis and Fatigue Fractures
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 3, 6Population: Reporting Group
including changes in the following parameters according to DVO guidelines: Calcium, Phosphate, Creatinin-Clearance (Cockcroft-Gault), Alkaline Phosphatase, γGT, CRP
Outcome measures
| Measure |
Zoledronic Acid
n=34 Participants
single-dose zoledronic acid (Aclasta) with vitamin D 1000IU/d - 5 mg i.v.
|
Placebo
n=14 Participants
placebo with vitamin D 1000 IU/d (NaCl Solution)
|
|---|---|---|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Serum Calcium
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Serum Phosphate
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Serum Alkaline Phosphatase
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Gamma-GT
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Serum Creatinine
|
0 participants
|
1 participants
|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
C-reactives protein
|
0 participants
|
0 participants
|
Adverse Events
Zoledronic Acid
Serious events: 4 serious events
Other events: 34 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Zoledronic Acid
n=34 participants at risk
single-dose zoledronic acid (Aclasta) with vitamin D 1000IU/d - 5 mg i.v.
|
Placebo
n=14 participants at risk
placebo with vitamin D 1000 IU/d (NaCl Solution)
|
|---|---|---|
|
Vascular disorders
Hypertensive crisis
|
2.9%
1/34 • Number of events 1 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
0.00%
0/14 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
2.9%
1/34 • Number of events 1 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
0.00%
0/14 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/34 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
7.1%
1/14 • Number of events 1 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
|
Nervous system disorders
Paraesthesia
|
2.9%
1/34 • Number of events 1 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
0.00%
0/14 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.9%
1/34 • Number of events 1 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
0.00%
0/14 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.9%
1/34 • Number of events 1 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
0.00%
0/14 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
Other adverse events
| Measure |
Zoledronic Acid
n=34 participants at risk
single-dose zoledronic acid (Aclasta) with vitamin D 1000IU/d - 5 mg i.v.
|
Placebo
n=14 participants at risk
placebo with vitamin D 1000 IU/d (NaCl Solution)
|
|---|---|---|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/34 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
7.1%
1/14 • Number of events 1 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
|
General disorders
Asthenia
|
5.9%
2/34 • Number of events 34 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
0.00%
0/14 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
|
General disorders
Chills
|
23.5%
8/34 • Number of events 8 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
14.3%
2/14 • Number of events 2 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
|
General disorders
Fatigue
|
29.4%
10/34 • Number of events 11 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
21.4%
3/14 • Number of events 3 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
|
General disorders
Influenza like illness
|
8.8%
3/34 • Number of events 3 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
14.3%
2/14 • Number of events 3 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
|
General disorders
Malaise
|
8.8%
3/34 • Number of events 3 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
0.00%
0/14 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
|
General disorders
Pyrexia
|
20.6%
7/34 • Number of events 7 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
7.1%
1/14 • Number of events 1 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/34 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
7.1%
1/14 • Number of events 1 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/34 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
7.1%
1/14 • Number of events 1 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
|
Investigations
Blood creatinine increased
|
0.00%
0/34 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
7.1%
1/14 • Number of events 1 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
|
Investigations
C-reactive protein increased
|
5.9%
2/34 • Number of events 2 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
0.00%
0/14 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.9%
2/34 • Number of events 2 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
0.00%
0/14 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
|
Nervous system disorders
Headache
|
38.2%
13/34 • Number of events 14 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
35.7%
5/14 • Number of events 6 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
|
Nervous system disorders
Sciatica
|
2.9%
1/34 • Number of events 1 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
7.1%
1/14 • Number of events 1 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
|
Eye disorders
Blepharospasm
|
5.9%
2/34 • Number of events 2 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
0.00%
0/14 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
5.9%
2/34 • Number of events 2 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
7.1%
1/14 • Number of events 1 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
11.8%
4/34 • Number of events 4 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
0.00%
0/14 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/34 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
7.1%
1/14 • Number of events 1 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/34 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
7.1%
1/14 • Number of events 2 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
|
Gastrointestinal disorders
Nausea
|
5.9%
2/34 • Number of events 2 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
14.3%
2/14 • Number of events 2 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/34 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
7.1%
1/14 • Number of events 1 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/34 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
7.1%
1/14 • Number of events 1 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/34 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
7.1%
1/14 • Number of events 1 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
32.4%
11/34 • Number of events 11 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
21.4%
3/14 • Number of events 4 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.8%
3/34 • Number of events 3 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
14.3%
2/14 • Number of events 2 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.8%
4/34 • Number of events 4 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
0.00%
0/14 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.9%
2/34 • Number of events 2 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
0.00%
0/14 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
5.9%
2/34 • Number of events 2 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
7.1%
1/14 • Number of events 1 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/34 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
21.4%
3/14 • Number of events 3 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
5.9%
2/34 • Number of events 2 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
7.1%
1/14 • Number of events 2 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Rheumatic disorder
|
5.9%
2/34 • Number of events 2 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
0.00%
0/14 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
5.9%
2/34 • Number of events 2 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
21.4%
3/14 • Number of events 3 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/34 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
7.1%
1/14 • Number of events 1 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
|
Infections and infestations
Cystitis
|
0.00%
0/34 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
7.1%
1/14 • Number of events 1 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/34 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
7.1%
1/14 • Number of events 1 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
|
Infections and infestations
Influenza
|
2.9%
1/34 • Number of events 1 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
21.4%
3/14 • Number of events 3 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
|
Infections and infestations
Nasopharyngitis
|
11.8%
4/34 • Number of events 4 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
14.3%
2/14 • Number of events 2 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/34 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
7.1%
1/14 • Number of events 1 • Adverse events were recorded from time of enrollment until completion of follow up, i.e. for 12 weeks
|
Additional Information
Dr. Lothar Seefried
University Hospital Wuerzburg - Department of Orthopaedics (Clinical Study Unit)
Phone: +499318033590
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place