Trial Outcomes & Findings for Safety of Intravenous Neridronic Acid in CRPS (NCT NCT02972359)
NCT ID: NCT02972359
Last Updated: 2019-11-21
Results Overview
The primary endpoint of this trial was a binary endpoint assessing whether or not a participant experienced any TEAE.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
580 participants
Primary outcome timeframe
Day 1 to Week 52
Results posted on
2019-11-21
Participant Flow
The first participant was enrolled on 20 December 2016.
A total of 580 participants signed an informed consent form, 318 participants hereof were allocated to treatment. Two of the allocated participants did not meet inclusion criteria/met exclusion criteria, thus 316 participants received treatment.
Participant milestones
| Measure |
Neridronic Acid
Neridronic acid 100 mg administered on Day 1, Day 4, Day 7, and Day 10, resulting in a total dose of neridronic acid 400 mg as intravenous infusion.
|
|---|---|
|
Overall Study
STARTED
|
318
|
|
Overall Study
COMPLETED
|
247
|
|
Overall Study
NOT COMPLETED
|
71
|
Reasons for withdrawal
| Measure |
Neridronic Acid
Neridronic acid 100 mg administered on Day 1, Day 4, Day 7, and Day 10, resulting in a total dose of neridronic acid 400 mg as intravenous infusion.
|
|---|---|
|
Overall Study
Incl. criteria not met/Exclusion met
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Death
|
1
|
|
Overall Study
Withdrawal by Subject
|
30
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Lost to Follow-up
|
26
|
|
Overall Study
Other reasons
|
5
|
|
Overall Study
Missing
|
1
|
Baseline Characteristics
One participant's baseline pain assessment was missing (N=315). Full Analysis Set
Baseline characteristics by cohort
| Measure |
Neridronic Acid
n=316 Participants
Neridronic acid 100 mg administered on Day 1, Day 4, Day 7, and Day 10, resulting in a total dose of neridronic acid 400 mg.
Neridronic acid: Neridronic acid administered as intravenous infusion.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=316 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
290 Participants
n=316 Participants
|
|
Age, Categorical
>=65 years
|
26 Participants
n=316 Participants
|
|
Age, Continuous
|
47.4 years
n=316 Participants
|
|
Sex: Female, Male
Female
|
237 Participants
n=316 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=316 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=316 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
300 Participants
n=316 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=316 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=316 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=316 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=316 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=316 Participants
|
|
Race (NIH/OMB)
White
|
297 Participants
n=316 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=316 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=316 Participants
|
|
Region of Enrollment
United States
|
308 participants
n=316 Participants
|
|
Region of Enrollment
Germany
|
8 participants
n=316 Participants
|
|
Body mass index (BMI)
|
28.3 kg/m^2
STANDARD_DEVIATION 7.4 • n=316 Participants
|
|
Baseline current pain intensity 11-point NRS
|
6.59 units on a scale
STANDARD_DEVIATION 1.58 • n=315 Participants • One participant's baseline pain assessment was missing (N=315). Full Analysis Set
|
|
Baseline Pain Interference score of the Brief Pain Inventory (BPI)
|
7.3 units on a scale
STANDARD_DEVIATION 1.75 • n=296 Participants • 20 participants baseline pain assessment were missing. Full Analysis Set
|
PRIMARY outcome
Timeframe: Day 1 to Week 52Population: Safety Set
The primary endpoint of this trial was a binary endpoint assessing whether or not a participant experienced any TEAE.
Outcome measures
| Measure |
Neridronic Acid
n=316 Participants
Neridronic acid 100 mg administered on Day 1, Day 4, Day 7, and Day 10, resulting in a total dose of neridronic acid 400 mg.
Neridronic acid: Neridronic acid administered as intravenous infusion.
|
|---|---|
|
Number of Participants With Occurrence of Any Treatment Emergent Adverse Event (TEAE)
Participants with TEAE
|
277 Participants
|
|
Number of Participants With Occurrence of Any Treatment Emergent Adverse Event (TEAE)
Participants with serious TEAE
|
27 Participants
|
|
Number of Participants With Occurrence of Any Treatment Emergent Adverse Event (TEAE)
Participants with non-serious TEAE
|
275 Participants
|
|
Number of Participants With Occurrence of Any Treatment Emergent Adverse Event (TEAE)
Participants with unexpected TEAE
|
267 Participants
|
|
Number of Participants With Occurrence of Any Treatment Emergent Adverse Event (TEAE)
Participants with related TEAE
|
190 Participants
|
|
Number of Participants With Occurrence of Any Treatment Emergent Adverse Event (TEAE)
Participants with related serious TEAE
|
3 Participants
|
|
Number of Participants With Occurrence of Any Treatment Emergent Adverse Event (TEAE)
Participants with TEAE leading to IMP discont.
|
12 Participants
|
|
Number of Participants With Occurrence of Any Treatment Emergent Adverse Event (TEAE)
Participants with TEAE leading to trial discont.
|
6 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 10Population: Safety Set
The investigator could choose to permanently discontinue a participant from treatment if continued exposure of the participant to neridronic acid could have posed an undue risk to the participant.
Outcome measures
| Measure |
Neridronic Acid
n=316 Participants
Neridronic acid 100 mg administered on Day 1, Day 4, Day 7, and Day 10, resulting in a total dose of neridronic acid 400 mg.
Neridronic acid: Neridronic acid administered as intravenous infusion.
|
|---|---|
|
Number of Participants With Occurrence of Permanent Discontinuation From Treatment Due to an Adverse Event
|
12 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 12 and Week 26Population: Full Analysis Set
The current Complex Regional Pain Syndrome (CRPS)-related pain intensity score was captured at each visit using an 11-point numerical rating scale where 0 = "no pain" and 10 = "pain as bad as you can imagine", a higher score indicates more pain.
Outcome measures
| Measure |
Neridronic Acid
n=316 Participants
Neridronic acid 100 mg administered on Day 1, Day 4, Day 7, and Day 10, resulting in a total dose of neridronic acid 400 mg.
Neridronic acid: Neridronic acid administered as intravenous infusion.
|
|---|---|
|
Change From Baseline in the Current Pain Intensity Score
Baseline to Week 12
|
-1.54 units on a scale
Standard Deviation 2.27
|
|
Change From Baseline in the Current Pain Intensity Score
Baseline to Week 26
|
-1.57 units on a scale
Standard Deviation 2.45
|
SECONDARY outcome
Timeframe: Baseline, at Week 12 and Week 26Population: Full Analysis Set
Participants with at least a 30 percent decrease in the current pain intensity score were considered to have responded to treatment.
Outcome measures
| Measure |
Neridronic Acid
n=316 Participants
Neridronic acid 100 mg administered on Day 1, Day 4, Day 7, and Day 10, resulting in a total dose of neridronic acid 400 mg.
Neridronic acid: Neridronic acid administered as intravenous infusion.
|
|---|---|
|
Number of Participants With Response to Treatment, Defined as at Least 30% Decrease From Baseline in the Current Pain Intensity Score
At least 30% pain reduction - Week 12
|
105 Participants
|
|
Number of Participants With Response to Treatment, Defined as at Least 30% Decrease From Baseline in the Current Pain Intensity Score
At least 30% pain reduction - Week 26
|
110 Participants
|
SECONDARY outcome
Timeframe: Baseline, at Week 12 and Week 26Population: Full Analysis Set
Participants with at least a 50 percent decrease in the current pain intensity score were considered to have responded to treatment.
Outcome measures
| Measure |
Neridronic Acid
n=316 Participants
Neridronic acid 100 mg administered on Day 1, Day 4, Day 7, and Day 10, resulting in a total dose of neridronic acid 400 mg.
Neridronic acid: Neridronic acid administered as intravenous infusion.
|
|---|---|
|
Number of Participants With Response to Treatment, Defined as at Least 50% Decrease From Baseline in the Current Pain Intensity Score
At least 50% pain reduction - Week 12
|
75 Participants
|
|
Number of Participants With Response to Treatment, Defined as at Least 50% Decrease From Baseline in the Current Pain Intensity Score
At least 50% pain reduction - Week 26
|
74 Participants
|
SECONDARY outcome
Timeframe: at Week 12Population: Full Analysis Set; 286 out of 316 participants attended the visit at Week 12 and were asked to complete the PGIC questionnaire.
The Patient Global Impression of Change (PGIC) is a self-reported measure of perceived change in overall condition since the start of the study. Participants selected one of seven responses ranging from "very much improved" to "very much worse". A response of "very much improved" or "much improved" is generally regarded as a clinically important improvement.
Outcome measures
| Measure |
Neridronic Acid
n=286 Participants
Neridronic acid 100 mg administered on Day 1, Day 4, Day 7, and Day 10, resulting in a total dose of neridronic acid 400 mg.
Neridronic acid: Neridronic acid administered as intravenous infusion.
|
|---|---|
|
Patient Global Impression of Change (PGIC) at Week 12
Very Much Improved
|
31 Participants
|
|
Patient Global Impression of Change (PGIC) at Week 12
Much Improved
|
71 Participants
|
|
Patient Global Impression of Change (PGIC) at Week 12
Minimally Improved
|
98 Participants
|
|
Patient Global Impression of Change (PGIC) at Week 12
No Change
|
45 Participants
|
|
Patient Global Impression of Change (PGIC) at Week 12
Minimally Worse
|
23 Participants
|
|
Patient Global Impression of Change (PGIC) at Week 12
Much Worse
|
12 Participants
|
|
Patient Global Impression of Change (PGIC) at Week 12
Very Much Worse
|
3 Participants
|
|
Patient Global Impression of Change (PGIC) at Week 12
Missing
|
3 Participants
|
SECONDARY outcome
Timeframe: at Week 26Population: Full Analysis Set; 273 out of 316 participants attended the visit at Week 26 and were asked to complete the PGIC questionnaire.
The Patient Global Impression of Change (PGIC) is a self-reported measure of perceived change in overall condition since the start of the study. Participants selected one of seven responses ranging from "very much improved" to "very much worse". A response of "very much improved" or "much improved" is generally regarded as a clinically important improvement.
Outcome measures
| Measure |
Neridronic Acid
n=273 Participants
Neridronic acid 100 mg administered on Day 1, Day 4, Day 7, and Day 10, resulting in a total dose of neridronic acid 400 mg.
Neridronic acid: Neridronic acid administered as intravenous infusion.
|
|---|---|
|
Patient Global Impression of Change (PGIC) at Week 26
Very Much Improved
|
38 Participants
|
|
Patient Global Impression of Change (PGIC) at Week 26
Much Improved
|
58 Participants
|
|
Patient Global Impression of Change (PGIC) at Week 26
Minimally Improved
|
84 Participants
|
|
Patient Global Impression of Change (PGIC) at Week 26
No Change
|
52 Participants
|
|
Patient Global Impression of Change (PGIC) at Week 26
Minimally Worse
|
25 Participants
|
|
Patient Global Impression of Change (PGIC) at Week 26
Much Worse
|
10 Participants
|
|
Patient Global Impression of Change (PGIC) at Week 26
Very Much Worse
|
2 Participants
|
|
Patient Global Impression of Change (PGIC) at Week 26
Missing
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 12 and Week 26Population: Full Analysis Set
The Brief Pain Inventory (BPI) Interference Score is the mean value of 7 self-reported items in question 9 of the BPI Short Form Questionnaire. Participants rated their interference of pain with general activity, walking, work, sleep and other activities in the past 24 hours, with possible ratings from 0 (does not interfere) to 10 (completely interferes). The BPI interference Score ranges from 0 to 10, with higher values indicating greater pain interference of daily activities.
Outcome measures
| Measure |
Neridronic Acid
n=316 Participants
Neridronic acid 100 mg administered on Day 1, Day 4, Day 7, and Day 10, resulting in a total dose of neridronic acid 400 mg.
Neridronic acid: Neridronic acid administered as intravenous infusion.
|
|---|---|
|
Change in the Pain Interference Score of the Brief Pain Inventory (BPI)
Baseline to Week 12
|
-2.2 score on a scale
Standard Deviation 2.49
|
|
Change in the Pain Interference Score of the Brief Pain Inventory (BPI)
Baseline to Week 26
|
-2.1 score on a scale
Standard Deviation 2.64
|
Adverse Events
Neridronic Acid
Serious events: 27 serious events
Other events: 275 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Neridronic Acid
n=316 participants at risk
Neridronic acid 100 mg administered on Day 1, Day 4, Day 7, and Day 10, resulting in a total dose of neridronic acid 400 mg.
Neridronic acid: Neridronic acid administered as intravenous infusion.
|
|---|---|
|
Cardiac disorders
Angina unstable
|
0.32%
1/316 • Number of events 1 • Day 1 to Week 52
318 participants were allocated to treatment. Two participants did not meet inclusion criteria/met exclusion criteria, thus 316 participants were treated (Safety Set). Participants were questioned about possible adverse events with non-leading questions before administration of the IMP and at regular intervals thereafter. All adverse events reported spontaneously by participants at any time point were also documented. Treatment emergent adverse events are reported.
|
|
Cardiac disorders
Myocardial infarction
|
0.32%
1/316 • Number of events 1 • Day 1 to Week 52
318 participants were allocated to treatment. Two participants did not meet inclusion criteria/met exclusion criteria, thus 316 participants were treated (Safety Set). Participants were questioned about possible adverse events with non-leading questions before administration of the IMP and at regular intervals thereafter. All adverse events reported spontaneously by participants at any time point were also documented. Treatment emergent adverse events are reported.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.32%
1/316 • Number of events 1 • Day 1 to Week 52
318 participants were allocated to treatment. Two participants did not meet inclusion criteria/met exclusion criteria, thus 316 participants were treated (Safety Set). Participants were questioned about possible adverse events with non-leading questions before administration of the IMP and at regular intervals thereafter. All adverse events reported spontaneously by participants at any time point were also documented. Treatment emergent adverse events are reported.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.32%
1/316 • Number of events 1 • Day 1 to Week 52
318 participants were allocated to treatment. Two participants did not meet inclusion criteria/met exclusion criteria, thus 316 participants were treated (Safety Set). Participants were questioned about possible adverse events with non-leading questions before administration of the IMP and at regular intervals thereafter. All adverse events reported spontaneously by participants at any time point were also documented. Treatment emergent adverse events are reported.
|
|
Gastrointestinal disorders
Colitis
|
0.32%
1/316 • Number of events 1 • Day 1 to Week 52
318 participants were allocated to treatment. Two participants did not meet inclusion criteria/met exclusion criteria, thus 316 participants were treated (Safety Set). Participants were questioned about possible adverse events with non-leading questions before administration of the IMP and at regular intervals thereafter. All adverse events reported spontaneously by participants at any time point were also documented. Treatment emergent adverse events are reported.
|
|
General disorders
Chest pain
|
0.63%
2/316 • Number of events 3 • Day 1 to Week 52
318 participants were allocated to treatment. Two participants did not meet inclusion criteria/met exclusion criteria, thus 316 participants were treated (Safety Set). Participants were questioned about possible adverse events with non-leading questions before administration of the IMP and at regular intervals thereafter. All adverse events reported spontaneously by participants at any time point were also documented. Treatment emergent adverse events are reported.
|
|
General disorders
Condition aggravated
|
0.32%
1/316 • Number of events 1 • Day 1 to Week 52
318 participants were allocated to treatment. Two participants did not meet inclusion criteria/met exclusion criteria, thus 316 participants were treated (Safety Set). Participants were questioned about possible adverse events with non-leading questions before administration of the IMP and at regular intervals thereafter. All adverse events reported spontaneously by participants at any time point were also documented. Treatment emergent adverse events are reported.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.32%
1/316 • Number of events 1 • Day 1 to Week 52
318 participants were allocated to treatment. Two participants did not meet inclusion criteria/met exclusion criteria, thus 316 participants were treated (Safety Set). Participants were questioned about possible adverse events with non-leading questions before administration of the IMP and at regular intervals thereafter. All adverse events reported spontaneously by participants at any time point were also documented. Treatment emergent adverse events are reported.
|
|
Hepatobiliary disorders
Liver disorder
|
0.32%
1/316 • Number of events 1 • Day 1 to Week 52
318 participants were allocated to treatment. Two participants did not meet inclusion criteria/met exclusion criteria, thus 316 participants were treated (Safety Set). Participants were questioned about possible adverse events with non-leading questions before administration of the IMP and at regular intervals thereafter. All adverse events reported spontaneously by participants at any time point were also documented. Treatment emergent adverse events are reported.
|
|
Infections and infestations
Pneumonia
|
0.63%
2/316 • Number of events 2 • Day 1 to Week 52
318 participants were allocated to treatment. Two participants did not meet inclusion criteria/met exclusion criteria, thus 316 participants were treated (Safety Set). Participants were questioned about possible adverse events with non-leading questions before administration of the IMP and at regular intervals thereafter. All adverse events reported spontaneously by participants at any time point were also documented. Treatment emergent adverse events are reported.
|
|
Injury, poisoning and procedural complications
Fall
|
0.63%
2/316 • Number of events 2 • Day 1 to Week 52
318 participants were allocated to treatment. Two participants did not meet inclusion criteria/met exclusion criteria, thus 316 participants were treated (Safety Set). Participants were questioned about possible adverse events with non-leading questions before administration of the IMP and at regular intervals thereafter. All adverse events reported spontaneously by participants at any time point were also documented. Treatment emergent adverse events are reported.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.32%
1/316 • Number of events 1 • Day 1 to Week 52
318 participants were allocated to treatment. Two participants did not meet inclusion criteria/met exclusion criteria, thus 316 participants were treated (Safety Set). Participants were questioned about possible adverse events with non-leading questions before administration of the IMP and at regular intervals thereafter. All adverse events reported spontaneously by participants at any time point were also documented. Treatment emergent adverse events are reported.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.32%
1/316 • Number of events 1 • Day 1 to Week 52
318 participants were allocated to treatment. Two participants did not meet inclusion criteria/met exclusion criteria, thus 316 participants were treated (Safety Set). Participants were questioned about possible adverse events with non-leading questions before administration of the IMP and at regular intervals thereafter. All adverse events reported spontaneously by participants at any time point were also documented. Treatment emergent adverse events are reported.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.63%
2/316 • Number of events 2 • Day 1 to Week 52
318 participants were allocated to treatment. Two participants did not meet inclusion criteria/met exclusion criteria, thus 316 participants were treated (Safety Set). Participants were questioned about possible adverse events with non-leading questions before administration of the IMP and at regular intervals thereafter. All adverse events reported spontaneously by participants at any time point were also documented. Treatment emergent adverse events are reported.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.32%
1/316 • Number of events 1 • Day 1 to Week 52
318 participants were allocated to treatment. Two participants did not meet inclusion criteria/met exclusion criteria, thus 316 participants were treated (Safety Set). Participants were questioned about possible adverse events with non-leading questions before administration of the IMP and at regular intervals thereafter. All adverse events reported spontaneously by participants at any time point were also documented. Treatment emergent adverse events are reported.
|
|
Nervous system disorders
Loss of consciousness
|
0.32%
1/316 • Number of events 1 • Day 1 to Week 52
318 participants were allocated to treatment. Two participants did not meet inclusion criteria/met exclusion criteria, thus 316 participants were treated (Safety Set). Participants were questioned about possible adverse events with non-leading questions before administration of the IMP and at regular intervals thereafter. All adverse events reported spontaneously by participants at any time point were also documented. Treatment emergent adverse events are reported.
|
|
Nervous system disorders
Syncope
|
0.63%
2/316 • Number of events 2 • Day 1 to Week 52
318 participants were allocated to treatment. Two participants did not meet inclusion criteria/met exclusion criteria, thus 316 participants were treated (Safety Set). Participants were questioned about possible adverse events with non-leading questions before administration of the IMP and at regular intervals thereafter. All adverse events reported spontaneously by participants at any time point were also documented. Treatment emergent adverse events are reported.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.32%
1/316 • Number of events 1 • Day 1 to Week 52
318 participants were allocated to treatment. Two participants did not meet inclusion criteria/met exclusion criteria, thus 316 participants were treated (Safety Set). Participants were questioned about possible adverse events with non-leading questions before administration of the IMP and at regular intervals thereafter. All adverse events reported spontaneously by participants at any time point were also documented. Treatment emergent adverse events are reported.
|
|
Psychiatric disorders
Delirium
|
0.32%
1/316 • Number of events 1 • Day 1 to Week 52
318 participants were allocated to treatment. Two participants did not meet inclusion criteria/met exclusion criteria, thus 316 participants were treated (Safety Set). Participants were questioned about possible adverse events with non-leading questions before administration of the IMP and at regular intervals thereafter. All adverse events reported spontaneously by participants at any time point were also documented. Treatment emergent adverse events are reported.
|
|
Psychiatric disorders
Suicidal ideation
|
0.32%
1/316 • Number of events 1 • Day 1 to Week 52
318 participants were allocated to treatment. Two participants did not meet inclusion criteria/met exclusion criteria, thus 316 participants were treated (Safety Set). Participants were questioned about possible adverse events with non-leading questions before administration of the IMP and at regular intervals thereafter. All adverse events reported spontaneously by participants at any time point were also documented. Treatment emergent adverse events are reported.
|
|
Psychiatric disorders
Suicide attempt
|
0.63%
2/316 • Number of events 2 • Day 1 to Week 52
318 participants were allocated to treatment. Two participants did not meet inclusion criteria/met exclusion criteria, thus 316 participants were treated (Safety Set). Participants were questioned about possible adverse events with non-leading questions before administration of the IMP and at regular intervals thereafter. All adverse events reported spontaneously by participants at any time point were also documented. Treatment emergent adverse events are reported.
|
|
Reproductive system and breast disorders
Cystocele
|
0.32%
1/316 • Number of events 1 • Day 1 to Week 52
318 participants were allocated to treatment. Two participants did not meet inclusion criteria/met exclusion criteria, thus 316 participants were treated (Safety Set). Participants were questioned about possible adverse events with non-leading questions before administration of the IMP and at regular intervals thereafter. All adverse events reported spontaneously by participants at any time point were also documented. Treatment emergent adverse events are reported.
|
|
Surgical and medical procedures
Leg amputation
|
0.32%
1/316 • Number of events 1 • Day 1 to Week 52
318 participants were allocated to treatment. Two participants did not meet inclusion criteria/met exclusion criteria, thus 316 participants were treated (Safety Set). Participants were questioned about possible adverse events with non-leading questions before administration of the IMP and at regular intervals thereafter. All adverse events reported spontaneously by participants at any time point were also documented. Treatment emergent adverse events are reported.
|
Other adverse events
| Measure |
Neridronic Acid
n=316 participants at risk
Neridronic acid 100 mg administered on Day 1, Day 4, Day 7, and Day 10, resulting in a total dose of neridronic acid 400 mg.
Neridronic acid: Neridronic acid administered as intravenous infusion.
|
|---|---|
|
Nervous system disorders
Headache
|
20.6%
65/316 • Number of events 96 • Day 1 to Week 52
318 participants were allocated to treatment. Two participants did not meet inclusion criteria/met exclusion criteria, thus 316 participants were treated (Safety Set). Participants were questioned about possible adverse events with non-leading questions before administration of the IMP and at regular intervals thereafter. All adverse events reported spontaneously by participants at any time point were also documented. Treatment emergent adverse events are reported.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.5%
52/316 • Number of events 70 • Day 1 to Week 52
318 participants were allocated to treatment. Two participants did not meet inclusion criteria/met exclusion criteria, thus 316 participants were treated (Safety Set). Participants were questioned about possible adverse events with non-leading questions before administration of the IMP and at regular intervals thereafter. All adverse events reported spontaneously by participants at any time point were also documented. Treatment emergent adverse events are reported.
|
|
Gastrointestinal disorders
Nausea
|
10.8%
34/316 • Number of events 46 • Day 1 to Week 52
318 participants were allocated to treatment. Two participants did not meet inclusion criteria/met exclusion criteria, thus 316 participants were treated (Safety Set). Participants were questioned about possible adverse events with non-leading questions before administration of the IMP and at regular intervals thereafter. All adverse events reported spontaneously by participants at any time point were also documented. Treatment emergent adverse events are reported.
|
|
General disorders
Fatigue
|
10.1%
32/316 • Number of events 39 • Day 1 to Week 52
318 participants were allocated to treatment. Two participants did not meet inclusion criteria/met exclusion criteria, thus 316 participants were treated (Safety Set). Participants were questioned about possible adverse events with non-leading questions before administration of the IMP and at regular intervals thereafter. All adverse events reported spontaneously by participants at any time point were also documented. Treatment emergent adverse events are reported.
|
|
General disorders
Condition aggravated
|
9.5%
30/316 • Number of events 44 • Day 1 to Week 52
318 participants were allocated to treatment. Two participants did not meet inclusion criteria/met exclusion criteria, thus 316 participants were treated (Safety Set). Participants were questioned about possible adverse events with non-leading questions before administration of the IMP and at regular intervals thereafter. All adverse events reported spontaneously by participants at any time point were also documented. Treatment emergent adverse events are reported.
|
|
General disorders
Pain
|
8.9%
28/316 • Number of events 37 • Day 1 to Week 52
318 participants were allocated to treatment. Two participants did not meet inclusion criteria/met exclusion criteria, thus 316 participants were treated (Safety Set). Participants were questioned about possible adverse events with non-leading questions before administration of the IMP and at regular intervals thereafter. All adverse events reported spontaneously by participants at any time point were also documented. Treatment emergent adverse events are reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.5%
27/316 • Number of events 31 • Day 1 to Week 52
318 participants were allocated to treatment. Two participants did not meet inclusion criteria/met exclusion criteria, thus 316 participants were treated (Safety Set). Participants were questioned about possible adverse events with non-leading questions before administration of the IMP and at regular intervals thereafter. All adverse events reported spontaneously by participants at any time point were also documented. Treatment emergent adverse events are reported.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.9%
25/316 • Number of events 30 • Day 1 to Week 52
318 participants were allocated to treatment. Two participants did not meet inclusion criteria/met exclusion criteria, thus 316 participants were treated (Safety Set). Participants were questioned about possible adverse events with non-leading questions before administration of the IMP and at regular intervals thereafter. All adverse events reported spontaneously by participants at any time point were also documented. Treatment emergent adverse events are reported.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.9%
25/316 • Number of events 30 • Day 1 to Week 52
318 participants were allocated to treatment. Two participants did not meet inclusion criteria/met exclusion criteria, thus 316 participants were treated (Safety Set). Participants were questioned about possible adverse events with non-leading questions before administration of the IMP and at regular intervals thereafter. All adverse events reported spontaneously by participants at any time point were also documented. Treatment emergent adverse events are reported.
|
|
General disorders
Pyrexia
|
5.7%
18/316 • Number of events 19 • Day 1 to Week 52
318 participants were allocated to treatment. Two participants did not meet inclusion criteria/met exclusion criteria, thus 316 participants were treated (Safety Set). Participants were questioned about possible adverse events with non-leading questions before administration of the IMP and at regular intervals thereafter. All adverse events reported spontaneously by participants at any time point were also documented. Treatment emergent adverse events are reported.
|
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Musculoskeletal and connective tissue disorders
Bone pain
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5.4%
17/316 • Number of events 20 • Day 1 to Week 52
318 participants were allocated to treatment. Two participants did not meet inclusion criteria/met exclusion criteria, thus 316 participants were treated (Safety Set). Participants were questioned about possible adverse events with non-leading questions before administration of the IMP and at regular intervals thereafter. All adverse events reported spontaneously by participants at any time point were also documented. Treatment emergent adverse events are reported.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor reserves the right to review any proposed presentation of the results of this trial before they are submitted for publication or public disclosure. Neither party (e.g., the sponsor, the coordinating investigator) has the right to prohibit publication or public disclosure unless it can be shown to affect possible patent rights.
- Publication restrictions are in place
Restriction type: OTHER