Trial Outcomes & Findings for Zoledronic Acid in the Prevention of Bone Loss in Postmenopausal Women With Osteopenia, 45 Years of Age and Older (NCT NCT00132808)
NCT ID: NCT00132808
Last Updated: 2016-09-12
Results Overview
The percentage change in lumbar spine BMD at Month 24 relative to baseline was derived as 100 x (lumbar spine BMD at 24 Month - lumbar spine BMD at baseline) / (lumbar spine BMD at baseline).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
581 participants
Primary outcome timeframe
Baseline, Month 24
Results posted on
2016-09-12
Participant Flow
Eligible patients were stratified according to their duration of menopause (those less than 5 years from menopause were included in Stratum I, while those 5 or more years from menopause were included in Stratum II), and randomized equally to one of the three treatment groups.
Participant milestones
| Measure |
Zoledronic Acid 2x5 mg
Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
|
Zoledronic Acid 1x5 mg
Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
|
Placebo
Placebo given at randomization and Month 12
|
|---|---|---|---|
|
Stratum I
STARTED
|
77
|
70
|
77
|
|
Stratum I
COMPLETED
|
68
|
58
|
72
|
|
Stratum I
NOT COMPLETED
|
9
|
12
|
5
|
|
Stratum II
STARTED
|
121
|
111
|
125
|
|
Stratum II
COMPLETED
|
113
|
96
|
116
|
|
Stratum II
NOT COMPLETED
|
8
|
15
|
9
|
Reasons for withdrawal
| Measure |
Zoledronic Acid 2x5 mg
Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
|
Zoledronic Acid 1x5 mg
Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
|
Placebo
Placebo given at randomization and Month 12
|
|---|---|---|---|
|
Stratum I
Adverse Event
|
2
|
1
|
0
|
|
Stratum I
Lost to Follow-up
|
3
|
4
|
1
|
|
Stratum I
Withdrawal by Subject
|
4
|
7
|
3
|
|
Stratum I
Abnormal test procedure result (s)
|
0
|
0
|
1
|
|
Stratum II
Adverse Event
|
1
|
2
|
1
|
|
Stratum II
Death
|
1
|
0
|
0
|
|
Stratum II
Lost to Follow-up
|
2
|
2
|
1
|
|
Stratum II
Protocol Violation
|
0
|
2
|
1
|
|
Stratum II
Withdrawal by Subject
|
4
|
9
|
6
|
Baseline Characteristics
Zoledronic Acid in the Prevention of Bone Loss in Postmenopausal Women With Osteopenia, 45 Years of Age and Older
Baseline characteristics by cohort
| Measure |
Zoledronic Acid 2x5 mg
n=198 Participants
Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
|
Zoledronic Acid 1x5 mg
n=181 Participants
Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
|
Placebo
n=202 Participants
Placebo given at randomization and Month 12
|
Total
n=581 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
Stratum I (Women < 5 Years From Menopause)
|
53.6 years
STANDARD_DEVIATION 3.62 • n=5 Participants
|
53.7 years
STANDARD_DEVIATION 3.59 • n=7 Participants
|
54.4 years
STANDARD_DEVIATION 3.83 • n=5 Participants
|
53.9 years
STANDARD_DEVIATION 3.68 • n=4 Participants
|
|
Age, Continuous
Stratum II (Women >= 5 Years From Menopause)
|
63.9 years
STANDARD_DEVIATION 6.62 • n=5 Participants
|
63.4 years
STANDARD_DEVIATION 7.74 • n=7 Participants
|
64.2 years
STANDARD_DEVIATION 7.65 • n=5 Participants
|
63.8 years
STANDARD_DEVIATION 7.34 • n=4 Participants
|
|
Sex: Female, Male
Female
|
198 Participants
n=5 Participants
|
181 Participants
n=7 Participants
|
202 Participants
n=5 Participants
|
581 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 24Population: Intent to treat population. Last observation carried forward (LOCF) was utilized to impute missing data.
The percentage change in lumbar spine BMD at Month 24 relative to baseline was derived as 100 x (lumbar spine BMD at 24 Month - lumbar spine BMD at baseline) / (lumbar spine BMD at baseline).
Outcome measures
| Measure |
Zoledronic Acid 2x5 mg
n=198 Participants
Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
|
Zoledronic Acid 1x5 mg
n=181 Participants
Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
|
Placebo
n=202 Participants
Placebo given at randomization and Month 12
|
|---|---|---|---|
|
Percentage Change in Lumbar Spine Bone Mineral Density (BMD) at Month 24 Relative to Baseline, by Stratum
Stratum I (Women < 5 Years From Menopause)
|
4.62 Percentage change in BMD
Standard Error 0.444 • Interval 5.77 to 7.96
|
4.03 Percentage change in BMD
Standard Error 0.444 • Interval 5.15 to 7.39
|
-2.24 Percentage change in BMD
Standard Error 0.428
|
|
Percentage Change in Lumbar Spine Bone Mineral Density (BMD) at Month 24 Relative to Baseline, by Stratum
Stratum II (Women >= 5 Years From Menopause)
|
5.60 Percentage change in BMD
Standard Error 0.343 • Interval 5.32 to 7.17
|
4.76 Percentage change in BMD
Standard Error 0.356 • Interval 4.46 to 6.36
|
-0.65 Percentage change in BMD
Standard Error 0.339
|
SECONDARY outcome
Timeframe: Baseline, Month 24Population: Intent to treat population with available data.
The percentage change in total hip BMD at Month 24 relative to baseline was derived as 100 x (total hip BMD at 24 Month - total hip BMD at baseline) / (total hip BMD at baseline).
Outcome measures
| Measure |
Zoledronic Acid 2x5 mg
n=198 Participants
Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
|
Zoledronic Acid 1x5 mg
n=181 Participants
Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
|
Placebo
n=202 Participants
Placebo given at randomization and Month 12
|
|---|---|---|---|
|
Percentage Change in Total Hip BMD at Month 24 Relative to Baseline, by Stratum.
Stratum I (Women < 5 Years From Menopause)
|
2.66 Percentage change in BMD
Standard Error 0.318 • Interval 4.0 to 5.52
|
2.55 Percentage change in BMD
Standard Error 0.317 • Interval 3.86 to 5.43
|
-2.10 Percentage change in BMD
Standard Error 0.293
|
|
Percentage Change in Total Hip BMD at Month 24 Relative to Baseline, by Stratum.
Stratum II (Women >= 5 Years From Menopause)
|
3.04 Percentage change in BMD
Standard Error 0.265 • Interval 3.36 to 4.8
|
2.11 Percentage change in BMD
Standard Error 0.282 • Interval 2.4 to 3.91
|
-1.04 Percentage change in BMD
Standard Error 0.265
|
SECONDARY outcome
Timeframe: Baseline, Month 24Population: Intent to treat population with available data.
The percentage change in femoral neck BMD at Month 24 relative to baseline was derived as 100 x (femoral neck BMD at 24 Month - femoral neck BMD at baseline) / (femoral neck BMD at baseline).
Outcome measures
| Measure |
Zoledronic Acid 2x5 mg
n=198 Participants
Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
|
Zoledronic Acid 1x5 mg
n=181 Participants
Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
|
Placebo
n=202 Participants
Placebo given at randomization and Month 12
|
|---|---|---|---|
|
Percentage Change in Femoral Neck BMD at Month 24 Relative to Baseline, by Stratum.
Stratum I (Women < 5 Years From Menopause)
|
2.04 Percentage change in BMD
Standard Error 0.550 • Interval 2.27 to 4.9
|
2.01 Percentage change in BMD
Standard Error 0.549 • Interval 2.2 to 4.92
|
-1.55 Percentage change in BMD
Standard Error 0.508
|
|
Percentage Change in Femoral Neck BMD at Month 24 Relative to Baseline, by Stratum.
Stratum II (Women >= 5 Years From Menopause)
|
2.35 Percentage change in BMD
Standard Error 0.344 • Interval 2.6 to 4.47
|
1.46 Percentage change in BMD
Standard Error 0.366 • Interval 1.67 to 3.62
|
-1.18 Percentage change in BMD
Standard Error 0.343
|
SECONDARY outcome
Timeframe: Months 6, 12, 18 and 24Population: Intent to treat population with available data.
Biomarker: Serum b-CTx levels at Months 6, 12, 18 and 24 by stratum.
Outcome measures
| Measure |
Zoledronic Acid 2x5 mg
n=198 Participants
Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
|
Zoledronic Acid 1x5 mg
n=181 Participants
Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
|
Placebo
n=202 Participants
Placebo given at randomization and Month 12
|
|---|---|---|---|
|
Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum
Stratum I - Month 6
|
0.2217 ng/mL
Standard Deviation 0.11791
|
0.2286 ng/mL
Standard Deviation 0.09630
|
0.6439 ng/mL
Standard Deviation 0.27902
|
|
Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum
Stratum I - Month 12
|
0.2861 ng/mL
Standard Deviation 0.13776
|
0.3111 ng/mL
Standard Deviation 0.13195
|
0.6634 ng/mL
Standard Deviation 0.25433
|
|
Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum
Stratum I - Month 18
|
0.2187 ng/mL
Standard Deviation 0.16812
|
0.3605 ng/mL
Standard Deviation 0.14847
|
0.6444 ng/mL
Standard Deviation 0.28254
|
|
Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum
Stratum I - Month 24
|
0.2864 ng/mL
Standard Deviation 0.12242
|
0.3777 ng/mL
Standard Deviation 0.14943
|
0.6640 ng/mL
Standard Deviation 0.27538
|
|
Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum
Stratum II - Month 6
|
0.1918 ng/mL
Standard Deviation 0.12648
|
0.1888 ng/mL
Standard Deviation 0.10625
|
0.5802 ng/mL
Standard Deviation 0.25034
|
|
Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum
Stratum II - Month 12
|
0.2696 ng/mL
Standard Deviation 0.18247
|
0.2484 ng/mL
Standard Deviation 0.11435
|
0.5634 ng/mL
Standard Deviation 0.23442
|
|
Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum
Stratum II - Month 18
|
0.1986 ng/mL
Standard Deviation 0.14900
|
0.2854 ng/mL
Standard Deviation 0.14391
|
0.5742 ng/mL
Standard Deviation 0.24399
|
|
Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum
Stratum II - Month 24
|
0.2554 ng/mL
Standard Deviation 0.17049
|
0.3254 ng/mL
Standard Deviation 0.15260
|
0.6012 ng/mL
Standard Deviation 0.26942
|
SECONDARY outcome
Timeframe: Months 6, 12, 18 and 24Population: Intent to treat population with available data.
Biomarker: Serum P1NP levels at Months 6, 12, 18 and 24 by stratum.
Outcome measures
| Measure |
Zoledronic Acid 2x5 mg
n=198 Participants
Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
|
Zoledronic Acid 1x5 mg
n=181 Participants
Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
|
Placebo
n=202 Participants
Placebo given at randomization and Month 12
|
|---|---|---|---|
|
Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum
Stratum I - Month 24
|
28.288 ng/mL
Standard Deviation 12.2706
|
38.743 ng/mL
Standard Deviation 14.7626
|
56.315 ng/mL
Standard Deviation 20.3715
|
|
Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum
Stratum I - Month 6
|
20.851 ng/mL
Standard Deviation 9.7724
|
20.752 ng/mL
Standard Deviation 9.7560
|
59.449 ng/mL
Standard Deviation 20.3291
|
|
Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum
Stratum I - Month 12
|
28.231 ng/mL
Standard Deviation 12.3748
|
30.500 ng/mL
Standard Deviation 14.8217
|
55.166 ng/mL
Standard Deviation 20.5274
|
|
Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum
Stratum I - Month 18
|
20.102 ng/mL
Standard Deviation 12.6635
|
35.561 ng/mL
Standard Deviation 14.1588
|
55.775 ng/mL
Standard Deviation 19.8842
|
|
Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum
Stratum II - Month 6
|
19.369 ng/mL
Standard Deviation 14.1819
|
19.423 ng/mL
Standard Deviation 16.6028
|
50.271 ng/mL
Standard Deviation 22.6624
|
|
Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum
Stratum II - Month 12
|
28.333 ng/mL
Standard Deviation 15.8193
|
26.363 ng/mL
Standard Deviation 13.1112
|
49.581 ng/mL
Standard Deviation 20.6559
|
|
Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum
Stratum II - Month 18
|
19.031 ng/mL
Standard Deviation 14.8270
|
29.569 ng/mL
Standard Deviation 14.7631
|
46.943 ng/mL
Standard Deviation 18.8147
|
|
Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum
Stratum II - Month 24
|
26.211 ng/mL
Standard Deviation 11.8566
|
34.418 ng/mL
Standard Deviation 15.4474
|
51.621 ng/mL
Standard Deviation 20.9281
|
SECONDARY outcome
Timeframe: Months 6, 12, 18 and 24Population: Intent to treat population with available data.
Biomarker: BSAP levels at Months 6, 12, 18 and 24 by stratum.
Outcome measures
| Measure |
Zoledronic Acid 2x5 mg
n=198 Participants
Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
|
Zoledronic Acid 1x5 mg
n=181 Participants
Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
|
Placebo
n=202 Participants
Placebo given at randomization and Month 12
|
|---|---|---|---|
|
Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum
Stratum II - Month 12
|
9.678 ng/mL
Standard Deviation 3.0216
|
9.139 ng/mL
Standard Deviation 2.4558
|
13.650 ng/mL
Standard Deviation 4.8295
|
|
Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum
Stratum I - Month 6
|
8.718 ng/mL
Standard Deviation 2.5827
|
8.841 ng/mL
Standard Deviation 2.2434
|
13.982 ng/mL
Standard Deviation 4.7106
|
|
Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum
Stratum I - Month 12
|
9.945 ng/mL
Standard Deviation 2.9027
|
10.539 ng/mL
Standard Deviation 2.9800
|
14.127 ng/mL
Standard Deviation 4.8981
|
|
Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum
Stratum I - Month 18
|
8.365 ng/mL
Standard Deviation 2.5574
|
11.233 ng/mL
Standard Deviation 3.1563
|
14.149 ng/mL
Standard Deviation 4.8878
|
|
Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum
Stratum I - Month 24
|
9.799 ng/mL
Standard Deviation 2.5836
|
11.764 ng/mL
Standard Deviation 3.8401
|
14.353 ng/mL
Standard Deviation 4.9089
|
|
Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum
Stratum II - Month 6
|
8.219 ng/mL
Standard Deviation 2.8126
|
7.925 ng/mL
Standard Deviation 2.2847
|
13.394 ng/mL
Standard Deviation 5.2169
|
|
Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum
Stratum II - Month 18
|
8.357 ng/mL
Standard Deviation 2.2152
|
10.023 ng/mL
Standard Deviation 2.8237
|
13.222 ng/mL
Standard Deviation 4.9167
|
|
Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum
Stratum II - Month 24
|
9.730 ng/mL
Standard Deviation 2.7591
|
10.916 ng/mL
Standard Deviation 3.5878
|
13.902 ng/mL
Standard Deviation 4.6302
|
Adverse Events
Zoledronic Acid 2x5 mg
Serious events: 21 serious events
Other events: 177 other events
Deaths: 0 deaths
Zoledronic Acid 1x5 mg
Serious events: 17 serious events
Other events: 158 other events
Deaths: 0 deaths
Placebo
Serious events: 23 serious events
Other events: 160 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Zoledronic Acid 2x5 mg
n=198 participants at risk
Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
|
Zoledronic Acid 1x5 mg
n=181 participants at risk
Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
|
Placebo
n=202 participants at risk
Placebo given at randomization and Month 12
|
|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
1.0%
2/198
|
0.55%
1/181
|
0.50%
1/202
|
|
Endocrine disorders
Thyroid mass
|
0.51%
1/198
|
0.00%
0/181
|
0.00%
0/202
|
|
Eye disorders
Cataract
|
0.00%
0/198
|
0.00%
0/181
|
0.50%
1/202
|
|
Gastrointestinal disorders
Abdominal pain
|
1.0%
2/198
|
0.00%
0/181
|
0.50%
1/202
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/198
|
0.00%
0/181
|
0.50%
1/202
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/198
|
0.00%
0/181
|
0.50%
1/202
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/198
|
0.55%
1/181
|
0.00%
0/202
|
|
Gastrointestinal disorders
Dyspepsia
|
0.51%
1/198
|
0.00%
0/181
|
0.00%
0/202
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.51%
1/198
|
0.00%
0/181
|
0.00%
0/202
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/198
|
0.00%
0/181
|
0.50%
1/202
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/198
|
0.55%
1/181
|
0.00%
0/202
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/198
|
0.55%
1/181
|
0.00%
0/202
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.00%
0/198
|
0.00%
0/181
|
0.50%
1/202
|
|
Gastrointestinal disorders
Intestinal prolapse
|
0.00%
0/198
|
0.55%
1/181
|
0.00%
0/202
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/198
|
0.00%
0/181
|
0.50%
1/202
|
|
Gastrointestinal disorders
Nausea
|
0.51%
1/198
|
0.00%
0/181
|
0.00%
0/202
|
|
Gastrointestinal disorders
Pancreatitis
|
0.51%
1/198
|
0.00%
0/181
|
0.00%
0/202
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.51%
1/198
|
0.00%
0/181
|
0.00%
0/202
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.51%
1/198
|
0.00%
0/181
|
0.00%
0/202
|
|
Gastrointestinal disorders
Vomiting
|
0.51%
1/198
|
0.00%
0/181
|
0.00%
0/202
|
|
General disorders
Non-cardiac chest pain
|
1.0%
2/198
|
1.7%
3/181
|
0.50%
1/202
|
|
Hepatobiliary disorders
Cholecystitis
|
0.51%
1/198
|
0.00%
0/181
|
0.00%
0/202
|
|
Immune system disorders
Hypersensitivity
|
0.51%
1/198
|
0.00%
0/181
|
0.00%
0/202
|
|
Infections and infestations
Bronchitis
|
0.00%
0/198
|
0.00%
0/181
|
0.50%
1/202
|
|
Infections and infestations
Cystitis
|
0.00%
0/198
|
0.00%
0/181
|
0.50%
1/202
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/198
|
0.55%
1/181
|
0.00%
0/202
|
|
Infections and infestations
Parotitis
|
0.00%
0/198
|
0.55%
1/181
|
0.00%
0/202
|
|
Infections and infestations
Pelvic abscess
|
0.51%
1/198
|
0.00%
0/181
|
0.00%
0/202
|
|
Infections and infestations
Sepsis
|
0.51%
1/198
|
0.00%
0/181
|
0.00%
0/202
|
|
Infections and infestations
Sinusitis
|
0.00%
0/198
|
0.00%
0/181
|
0.50%
1/202
|
|
Injury, poisoning and procedural complications
Collapse of lung
|
0.00%
0/198
|
0.00%
0/181
|
0.50%
1/202
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.51%
1/198
|
0.00%
0/181
|
0.00%
0/202
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/198
|
0.00%
0/181
|
0.50%
1/202
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/198
|
0.00%
0/181
|
0.50%
1/202
|
|
Metabolism and nutrition disorders
Dehydration
|
0.51%
1/198
|
0.00%
0/181
|
0.00%
0/202
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.51%
1/198
|
0.00%
0/181
|
0.00%
0/202
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/198
|
0.00%
0/181
|
0.50%
1/202
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/198
|
1.1%
2/181
|
0.00%
0/202
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.51%
1/198
|
0.55%
1/181
|
0.00%
0/202
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/198
|
0.00%
0/181
|
0.50%
1/202
|
|
Musculoskeletal and connective tissue disorders
Loose body in joint
|
0.00%
0/198
|
0.00%
0/181
|
0.50%
1/202
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/198
|
0.00%
0/181
|
0.50%
1/202
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.51%
1/198
|
0.00%
0/181
|
0.00%
0/202
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/198
|
0.55%
1/181
|
0.00%
0/202
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.51%
1/198
|
0.00%
0/181
|
0.00%
0/202
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.00%
0/198
|
0.55%
1/181
|
0.00%
0/202
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.51%
1/198
|
0.00%
0/181
|
0.00%
0/202
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.51%
1/198
|
0.55%
1/181
|
0.50%
1/202
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cardiac neoplasm unspecified
|
0.00%
0/198
|
0.00%
0/181
|
0.50%
1/202
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/198
|
0.55%
1/181
|
0.00%
0/202
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/198
|
0.55%
1/181
|
0.00%
0/202
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/198
|
0.00%
0/181
|
0.50%
1/202
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant peritoneal neoplasm
|
0.51%
1/198
|
0.00%
0/181
|
0.00%
0/202
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/198
|
0.00%
0/181
|
0.50%
1/202
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/198
|
0.00%
0/181
|
0.50%
1/202
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasopharyngeal cancer
|
0.00%
0/198
|
0.00%
0/181
|
0.50%
1/202
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neurilemmoma
|
0.00%
0/198
|
0.55%
1/181
|
0.00%
0/202
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.51%
1/198
|
0.00%
0/181
|
0.00%
0/202
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleural mesothelioma malignant
|
0.00%
0/198
|
0.00%
0/181
|
0.50%
1/202
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/198
|
0.55%
1/181
|
0.00%
0/202
|
|
Nervous system disorders
Convulsion
|
0.00%
0/198
|
0.00%
0/181
|
0.50%
1/202
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/198
|
0.00%
0/181
|
0.50%
1/202
|
|
Nervous system disorders
Global amnesia
|
0.51%
1/198
|
0.00%
0/181
|
0.00%
0/202
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/198
|
0.00%
0/181
|
0.50%
1/202
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/198
|
0.55%
1/181
|
0.00%
0/202
|
|
Nervous system disorders
Syncope
|
0.00%
0/198
|
0.55%
1/181
|
0.99%
2/202
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/198
|
0.55%
1/181
|
0.00%
0/202
|
|
Psychiatric disorders
Depression
|
0.00%
0/198
|
0.00%
0/181
|
0.50%
1/202
|
|
Psychiatric disorders
Psychotic disorder
|
0.51%
1/198
|
0.00%
0/181
|
0.00%
0/202
|
|
Renal and urinary disorders
Bladder prolapse
|
0.51%
1/198
|
0.00%
0/181
|
0.00%
0/202
|
|
Renal and urinary disorders
Pollakiuria
|
0.51%
1/198
|
0.00%
0/181
|
0.00%
0/202
|
|
Renal and urinary disorders
Renal failure acute
|
0.51%
1/198
|
0.00%
0/181
|
0.00%
0/202
|
|
Reproductive system and breast disorders
Endometrial metaplasia
|
0.51%
1/198
|
0.00%
0/181
|
0.00%
0/202
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/198
|
0.00%
0/181
|
0.50%
1/202
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/198
|
0.00%
0/181
|
0.50%
1/202
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/198
|
0.00%
0/181
|
0.50%
1/202
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/198
|
0.00%
0/181
|
0.50%
1/202
|
|
Vascular disorders
Arterial occlusive disease
|
0.51%
1/198
|
0.00%
0/181
|
0.00%
0/202
|
|
Vascular disorders
Hypertension
|
0.51%
1/198
|
0.00%
0/181
|
0.00%
0/202
|
|
Vascular disorders
Leriche syndrome
|
0.51%
1/198
|
0.00%
0/181
|
0.00%
0/202
|
|
Vascular disorders
Varicose vein
|
0.51%
1/198
|
0.00%
0/181
|
0.00%
0/202
|
Other adverse events
| Measure |
Zoledronic Acid 2x5 mg
n=198 participants at risk
Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
|
Zoledronic Acid 1x5 mg
n=181 participants at risk
Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
|
Placebo
n=202 participants at risk
Placebo given at randomization and Month 12
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
11/198
|
3.3%
6/181
|
3.0%
6/202
|
|
Gastrointestinal disorders
Constipation
|
6.6%
13/198
|
7.2%
13/181
|
6.9%
14/202
|
|
Gastrointestinal disorders
Diarrhoea
|
8.1%
16/198
|
6.6%
12/181
|
7.9%
16/202
|
|
Gastrointestinal disorders
Dyspepsia
|
6.6%
13/198
|
6.6%
12/181
|
5.0%
10/202
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.5%
9/198
|
2.8%
5/181
|
5.9%
12/202
|
|
Gastrointestinal disorders
Nausea
|
17.2%
34/198
|
11.6%
21/181
|
7.9%
16/202
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
14/198
|
5.0%
9/181
|
4.5%
9/202
|
|
General disorders
Asthenia
|
6.1%
12/198
|
2.8%
5/181
|
0.99%
2/202
|
|
General disorders
Chills
|
18.2%
36/198
|
18.2%
33/181
|
3.0%
6/202
|
|
General disorders
Fatigue
|
14.6%
29/198
|
9.9%
18/181
|
4.0%
8/202
|
|
General disorders
Non-cardiac chest pain
|
3.0%
6/198
|
6.6%
12/181
|
3.0%
6/202
|
|
General disorders
Oedema peripheral
|
5.6%
11/198
|
3.9%
7/181
|
3.5%
7/202
|
|
General disorders
Pain
|
24.2%
48/198
|
14.9%
27/181
|
3.5%
7/202
|
|
General disorders
Pyrexia
|
21.7%
43/198
|
21.0%
38/181
|
4.5%
9/202
|
|
Infections and infestations
Bronchitis
|
6.1%
12/198
|
7.7%
14/181
|
10.9%
22/202
|
|
Infections and infestations
Influenza
|
6.1%
12/198
|
8.3%
15/181
|
5.9%
12/202
|
|
Infections and infestations
Nasopharyngitis
|
13.6%
27/198
|
9.4%
17/181
|
11.4%
23/202
|
|
Infections and infestations
Sinusitis
|
8.1%
16/198
|
6.6%
12/181
|
11.9%
24/202
|
|
Infections and infestations
Upper respiratory tract infection
|
13.6%
27/198
|
10.5%
19/181
|
11.4%
23/202
|
|
Infections and infestations
Urinary tract infection
|
11.1%
22/198
|
8.8%
16/181
|
12.4%
25/202
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
3.5%
7/198
|
5.5%
10/181
|
2.0%
4/202
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
27.3%
54/198
|
18.8%
34/181
|
19.3%
39/202
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.2%
36/198
|
16.6%
30/181
|
11.9%
24/202
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.1%
10/198
|
3.3%
6/181
|
0.99%
2/202
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.6%
11/198
|
2.8%
5/181
|
5.0%
10/202
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.6%
11/198
|
5.5%
10/181
|
5.4%
11/202
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
19.2%
38/198
|
22.7%
41/181
|
6.9%
14/202
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.1%
10/198
|
6.6%
12/181
|
5.0%
10/202
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.5%
5/198
|
1.7%
3/181
|
7.9%
16/202
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.1%
22/198
|
16.0%
29/181
|
9.9%
20/202
|
|
Nervous system disorders
Dizziness
|
7.6%
15/198
|
6.1%
11/181
|
3.5%
7/202
|
|
Nervous system disorders
Headache
|
14.6%
29/198
|
20.4%
37/181
|
11.4%
23/202
|
|
Nervous system disorders
Hypoaesthesia
|
5.6%
11/198
|
2.2%
4/181
|
1.5%
3/202
|
|
Psychiatric disorders
Insomnia
|
3.0%
6/198
|
2.8%
5/181
|
5.9%
12/202
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.6%
17/198
|
6.1%
11/181
|
5.0%
10/202
|
|
Vascular disorders
Hypertension
|
4.5%
9/198
|
8.3%
15/181
|
6.9%
14/202
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER