Trial Outcomes & Findings for The Safety and Efficacy of Zoledronic Acid in the Prevention of Cancer Therapy Induced Bone Loss (NCT NCT00375505)
NCT ID: NCT00375505
Last Updated: 2015-09-07
Results Overview
Bone mineral density (BMD) by DXA at lumbar spine (L2-L4); DXA assessments of the BMD at dual hips. (BMD). Two X-ray beams with different energy levels are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone.
COMPLETED
PHASE3
70 participants
baseline, month 24
2015-09-07
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
Zometa
Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
34
|
|
Overall Study
COMPLETED
|
35
|
32
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
Zometa
Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
Baseline Characteristics
The Safety and Efficacy of Zoledronic Acid in the Prevention of Cancer Therapy Induced Bone Loss
Baseline characteristics by cohort
| Measure |
Placebo
n=36 Participants
Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
Zometa
n=34 Participants
Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.8 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
43.2 years
STANDARD_DEVIATION 6.0 • n=7 Participants
|
43.0 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, month 24Population: ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.
Bone mineral density (BMD) by DXA at lumbar spine (L2-L4); DXA assessments of the BMD at dual hips. (BMD). Two X-ray beams with different energy levels are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone.
Outcome measures
| Measure |
Placebo
n=36 Participants
Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
Zometa
n=34 Participants
Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
|---|---|---|
|
Change in Bone Mineral Density (BMD) Measured by Dual (Energy) X-ray Absorptiometry (DXA) at Lumbar Spine (L2-L4) From Baseline to Month 24
|
-0.075 Z-score
Standard Deviation 0.041
|
0.037 Z-score
Standard Deviation 0.042
|
PRIMARY outcome
Timeframe: baseline, month 24Population: ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.
Bone mineral density (BMD) at lumbar spine (L2-L4) by T-score. Your T-score is the number of units that your bone density is above or below the average. -1 and above-bone density is considered normal; Between -1 and -2.5-is a sign of osteopenia, a condition in which bone density is below normal and may lead to osteoporosis. -2.5 and below-indicates that it is likely osteoporosis.
Outcome measures
| Measure |
Placebo
n=36 Participants
Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
Zometa
n=34 Participants
Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
|---|---|---|
|
Change in Bone Mineral Density (BMD) at Lumbar Spine (L2-L4) From Baseline to Month 24 or Last Visit Measure by T-score
|
-0.622 T-score
Standard Deviation 0.346
|
0.309 T-score
Standard Deviation 0.348
|
PRIMARY outcome
Timeframe: baseline, month 24Population: ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.
Bone mineral density (BMD) at lumbar spine (L2-L4) measured by Z-score. If Z-score is -2 or lower, it may suggest that something other than aging is causing abnormal bone loss.
Outcome measures
| Measure |
Placebo
n=36 Participants
Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
Zometa
n=34 Participants
Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
|---|---|---|
|
Change in Bone Mineral Density (BMD) at Lumbar Spine (L2-L4) From Baseline to Month 24 or Last Visit Measure by Z-score
|
-0.658 Z-score
Standard Deviation 0.355
|
0.309 Z-score
Standard Deviation 0.414
|
PRIMARY outcome
Timeframe: baseline, month 24Population: ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.
Bone mineral density (BMD) at lumbar spine (L2-L4) measured by using Lunar or Hologic dual-energy X-ray absorptiometry (DXA) Instruments. Measurements were done in the lumbar vertebrae (L2-L4)
Outcome measures
| Measure |
Placebo
n=36 Participants
Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
Zometa
n=34 Participants
Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
|---|---|---|
|
Percent Change in Bone Mineral Density for L2-L4 From Baseline to Month 24 or Last Visit
|
-6.429 percentage change
Standard Deviation 3.414
|
3.139 percentage change
Standard Deviation 3.388
|
SECONDARY outcome
Timeframe: baseline, month 24Population: ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.
Bone mineral density (BMD) for femoral neck (right and left side) is measured by using Lunar or Hologic dual-energy X-ray absorptiometry (DXA) Instruments. Measurements were done on femoral neck (right and left side)
Outcome measures
| Measure |
Placebo
n=36 Participants
Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
Zometa
n=34 Participants
Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
|---|---|---|
|
Percentage Change in Bone Mineral Density for Femoral Neck (Right and Left Side) From Baseline to Month 24
femoral neck (right)
|
-0.023 Percentage Change
Standard Deviation 0.033
|
0.011 Percentage Change
Standard Deviation 0.021
|
|
Percentage Change in Bone Mineral Density for Femoral Neck (Right and Left Side) From Baseline to Month 24
femoral neck (left)
|
-0.023 Percentage Change
Standard Deviation 0.035
|
0.008 Percentage Change
Standard Deviation 0.028
|
SECONDARY outcome
Timeframe: baseline, month 24Population: ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.
Bone mineral density (BMD) for total femoral neck (right and left side) is measured by using Lunar or Hologic dual-energy X-ray absorptiometry (DXA) Instruments. Measurements were done on femoral neck (right and left side)
Outcome measures
| Measure |
Placebo
n=36 Participants
Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
Zometa
n=34 Participants
Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
|---|---|---|
|
Percentage Change in Bone Mineral Density for Total Femoral Neck (Right and Left Side) From Baseline to Month 24
femoral neck (right)
|
-0.039 percentage change
Standard Deviation 0.028
|
0.013 percentage change
Standard Deviation 0.018
|
|
Percentage Change in Bone Mineral Density for Total Femoral Neck (Right and Left Side) From Baseline to Month 24
femoral neck (left)
|
-0.036 percentage change
Standard Deviation 0.028
|
0.014 percentage change
Standard Deviation 0.018
|
SECONDARY outcome
Timeframe: baseline, month 24Population: ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.
Bone mineral density (BMD) for Os calcis (right and left side) is measured by SOS; SOS is a Quantitative ultrasonography scanning and measures bone mass and strength and assesses bone microarchitecture by detecting the transmission of high-frequency sound waves through bone.
Outcome measures
| Measure |
Placebo
n=36 Participants
Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
Zometa
n=34 Participants
Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
|---|---|---|
|
Change in Bone Mineral Density Os Calcis (Right and Left Side) From Baseline to Month 24 as Measured by Speed of Sound (SOS)
Os calcis (right)
|
-13.139 m/s
Standard Deviation 23.111
|
-10.853 m/s
Standard Deviation 16.613
|
|
Change in Bone Mineral Density Os Calcis (Right and Left Side) From Baseline to Month 24 as Measured by Speed of Sound (SOS)
Os calcis (left)
|
-13.028 m/s
Standard Deviation 19.761
|
-13.485 m/s
Standard Deviation 15.969
|
SECONDARY outcome
Timeframe: baseline, month 24Population: ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.
Bone mineral density (BMD) for Os calcis (right and left side) is measured by BUA; BUA is a Quantitative ultrasonography scanning and measures bone mass and strength and assesses bone microarchitecture by detecting the transmission of high-frequency sound waves through bone.
Outcome measures
| Measure |
Placebo
n=36 Participants
Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
Zometa
n=34 Participants
Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
|---|---|---|
|
Change in Bone Mineral Density Os Calcis (Right and Left Side) From Baseline to Month 24 as Measured by Broadband Ultrasound Attenuation (BUA)
Os calcis (right)
|
-0.306 dB/MHz
Standard Deviation 11.369
|
1.824 dB/MHz
Standard Deviation 8.997
|
|
Change in Bone Mineral Density Os Calcis (Right and Left Side) From Baseline to Month 24 as Measured by Broadband Ultrasound Attenuation (BUA)
Os calcis (left)
|
-2.417 dB/MHz
Standard Deviation 12.514
|
1.848 dB/MHz
Standard Deviation 9.628
|
SECONDARY outcome
Timeframe: baseline, month 24Population: ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.
Bone mineral density (BMD) for Phalanges II, III, IV, and V is measured by ADSOS; ADSOS is a Quantitative ultrasonography scanning and measures bone mass and strength and assesses bone microarchitecture by detecting the transmission of high-frequency sound waves through bone.
Outcome measures
| Measure |
Placebo
n=36 Participants
Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
Zometa
n=34 Participants
Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
|---|---|---|
|
Change in Bone Mineral Density Phalanges II, III, IV, and V From Baseline to Month 24 or Last Visit as Measured by Amplitude-dependent Speed of Sound (ADSOS)
Phalanges II (n=35, 33)
|
-48.514 m/s
Standard Deviation 50.905
|
-21.485 m/s
Standard Deviation 78.284
|
|
Change in Bone Mineral Density Phalanges II, III, IV, and V From Baseline to Month 24 or Last Visit as Measured by Amplitude-dependent Speed of Sound (ADSOS)
Phalanges III (n=35, 33)
|
-62.971 m/s
Standard Deviation 53.760
|
-19.879 m/s
Standard Deviation 70.968
|
|
Change in Bone Mineral Density Phalanges II, III, IV, and V From Baseline to Month 24 or Last Visit as Measured by Amplitude-dependent Speed of Sound (ADSOS)
Phalanges IV (n=35, 33)
|
-49.086 m/s
Standard Deviation 61.990
|
0.455 m/s
Standard Deviation 93.598
|
|
Change in Bone Mineral Density Phalanges II, III, IV, and V From Baseline to Month 24 or Last Visit as Measured by Amplitude-dependent Speed of Sound (ADSOS)
Phalanges V (n=35, 33)
|
-35.000 m/s
Standard Deviation 38.072
|
0.303 m/s
Standard Deviation 79.985
|
SECONDARY outcome
Timeframe: baseline, month 24Population: ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.
CTX is a telopeptide that can be used as a biomarker in the serum to measure the rate of bone turnover. The test used to detect the CTX marker is specific to bone resorption.
Outcome measures
| Measure |
Placebo
n=36 Participants
Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
Zometa
n=34 Participants
Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
|---|---|---|
|
Change in Serum CTX-carboxy-terminal Collagen Crosslinks From Baseline to Month 24
|
0.137 ng/mL
Standard Deviation 0.164
|
-0.118 ng/mL
Standard Deviation 0.110
|
SECONDARY outcome
Timeframe: baseline, month 24Population: ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.
Change in Aminoterminal propeptide on type I procollagen (P1NP) from baseline to month 24. P1NP is a marker for bone formation. It is a specific indicator of type 1 collagen deposition. P1NP is increased in states of high bone turnover
Outcome measures
| Measure |
Placebo
n=36 Participants
Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
Zometa
n=34 Participants
Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
|---|---|---|
|
Change in Aminoterminal Propeptide on Type I Procollagen (P1NP) From Baseline to Month 24
|
16.729 ng/ml
Standard Deviation 19.346
|
-21.476 ng/ml
Standard Deviation 13.142
|
SECONDARY outcome
Timeframe: baseline, month 24Population: ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.
Change in Estradiol from baseline to month 24
Outcome measures
| Measure |
Placebo
n=36 Participants
Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
Zometa
n=34 Participants
Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
|---|---|---|
|
Change in Estradiol (E2) From Baseline to Month 24
|
-119.026 ng/L
Standard Deviation 213.030
|
-10.421 ng/L
Standard Deviation 134.529
|
SECONDARY outcome
Timeframe: baseline, month 24Population: ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.
Change in Follicle- Stimulating Hormone (FSH) from baseline to month 24
Outcome measures
| Measure |
Placebo
n=36 Participants
Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
Zometa
n=34 Participants
Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
|---|---|---|
|
Change in Follicle- Stimulating Hormone (FSH) From Baseline to Month 24
|
-0.593 mIU/ml
Standard Deviation 36.851
|
0.860 mIU/ml
Standard Deviation 28.444
|
SECONDARY outcome
Timeframe: baseline, month 24Population: ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.
Change in Testosterone from baseline to month 24
Outcome measures
| Measure |
Placebo
n=36 Participants
Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
Zometa
n=34 Participants
Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
|---|---|---|
|
Change in Testosterone From Baseline to Month 24
|
0.039 ng/ml
Standard Deviation 0.110
|
0.015 ng/ml
Standard Deviation 0.111
|
SECONDARY outcome
Timeframe: baseline, month 24Population: ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.
Change in Sex Hormone binding globulin (SHGB) from baseline to month 24
Outcome measures
| Measure |
Placebo
n=36 Participants
Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
Zometa
n=34 Participants
Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
|---|---|---|
|
Change in Sex Hormone Binding Globulin (SHGB) From Baseline to Month 24
|
5.609 nmol/l
Standard Deviation 45.614
|
12.806 nmol/l
Standard Deviation 32.501
|
SECONDARY outcome
Timeframe: baseline, month 24Population: ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.
Change in Parathyroid Hormone (PTH) from baseline to month 24
Outcome measures
| Measure |
Placebo
n=36 Participants
Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
Zometa
n=34 Participants
Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
|---|---|---|
|
Change in Parathyroid Hormone (PTH) From Baseline to Month 24
|
7.288 pg/ml
Standard Deviation 12.838
|
4.729 pg/ml
Standard Deviation 10.401
|
SECONDARY outcome
Timeframe: baseline, month 24Population: ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.
Change in Vitamine D from baseline to month 24
Outcome measures
| Measure |
Placebo
n=36 Participants
Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
Zometa
n=34 Participants
Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
|---|---|---|
|
Change in Vitamine D From Baseline to Month 24
|
11.163 ng/ml
Standard Deviation 9.234
|
9.638 ng/ml
Standard Deviation 9.242
|
SECONDARY outcome
Timeframe: baseline, month 24Population: ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.
Change in anti-Mueller hormone (AMH) from baseline to month 24
Outcome measures
| Measure |
Placebo
n=36 Participants
Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
Zometa
n=34 Participants
Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
|---|---|---|
|
Change in Anti-Mueller Hormone (AMH) From Baseline to Month 24
|
-0.584 ng/ml
Standard Deviation 0.962
|
-0.878 ng/ml
Standard Deviation 2.019
|
SECONDARY outcome
Timeframe: baseline, month 24Population: ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available.
Change in Inhibin A and Inhibin B from baseline to month 24
Outcome measures
| Measure |
Placebo
n=36 Participants
Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
Zometa
n=34 Participants
Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
|---|---|---|
|
Change in Inhibin A and Inhibin B From Baseline to Month 24
Inhibin B (n=34,34)
|
-28.200 pg/ml
Standard Deviation 41.545
|
-39.126 pg/ml
Standard Deviation 43.421
|
|
Change in Inhibin A and Inhibin B From Baseline to Month 24
Inhibin A (n=34,34)
|
-19.079 pg/ml
Standard Deviation 29.592
|
-10.209 pg/ml
Standard Deviation 24.125
|
Adverse Events
Placebo
Zometa
Serious adverse events
| Measure |
Placebo
n=36 participants at risk
Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
Zometa
n=34 participants at risk
Zometa
|
|---|---|---|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/36
|
2.9%
1/34
|
|
Gastrointestinal disorders
DENTAL CARIES
|
2.8%
1/36
|
0.00%
0/34
|
|
Gastrointestinal disorders
GASTROINTESTINAL OEDEMA
|
2.8%
1/36
|
0.00%
0/34
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
0.00%
0/36
|
2.9%
1/34
|
|
Gastrointestinal disorders
PANCREATITIS
|
2.8%
1/36
|
0.00%
0/34
|
|
General disorders
PYREXIA
|
2.8%
1/36
|
0.00%
0/34
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
0.00%
0/36
|
2.9%
1/34
|
|
Infections and infestations
FEBRILE INFECTION
|
0.00%
0/36
|
2.9%
1/34
|
|
Infections and infestations
SUBCUTANEOUS ABSCESS
|
2.8%
1/36
|
0.00%
0/34
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS
|
0.00%
0/36
|
2.9%
1/34
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
2.8%
1/36
|
2.9%
1/34
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OSTEOMA
|
2.8%
1/36
|
0.00%
0/34
|
|
Nervous system disorders
ATAXIA
|
0.00%
0/36
|
2.9%
1/34
|
|
Nervous system disorders
CEREBRAL HAEMORRHAGE
|
0.00%
0/36
|
2.9%
1/34
|
|
Psychiatric disorders
DEPRESSION
|
2.8%
1/36
|
0.00%
0/34
|
|
Reproductive system and breast disorders
MENORRHAGIA
|
2.8%
1/36
|
0.00%
0/34
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
2.8%
1/36
|
0.00%
0/34
|
|
Surgical and medical procedures
ADENOIDECTOMY
|
2.8%
1/36
|
0.00%
0/34
|
|
Surgical and medical procedures
HYSTERECTOMY
|
2.8%
1/36
|
0.00%
0/34
|
Other adverse events
| Measure |
Placebo
n=36 participants at risk
Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
|
Zometa
n=34 participants at risk
Zometa
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
8.3%
3/36
|
0.00%
0/34
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
11.1%
4/36
|
5.9%
2/34
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
5.6%
2/36
|
0.00%
0/34
|
|
Eye disorders
VISUAL IMPAIRMENT
|
5.6%
2/36
|
0.00%
0/34
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
2.8%
1/36
|
5.9%
2/34
|
|
Gastrointestinal disorders
CONSTIPATION
|
5.6%
2/36
|
0.00%
0/34
|
|
Gastrointestinal disorders
GASTRITIS
|
2.8%
1/36
|
5.9%
2/34
|
|
Gastrointestinal disorders
NAUSEA
|
13.9%
5/36
|
23.5%
8/34
|
|
General disorders
CHILLS
|
2.8%
1/36
|
20.6%
7/34
|
|
General disorders
FATIGUE
|
2.8%
1/36
|
5.9%
2/34
|
|
General disorders
IMPAIRED HEALING
|
5.6%
2/36
|
0.00%
0/34
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
11.1%
4/36
|
32.4%
11/34
|
|
General disorders
PYREXIA
|
2.8%
1/36
|
8.8%
3/34
|
|
Infections and infestations
BRONCHITIS
|
2.8%
1/36
|
11.8%
4/34
|
|
Infections and infestations
CYSTITIS
|
8.3%
3/36
|
5.9%
2/34
|
|
Infections and infestations
GASTROENTERITIS
|
5.6%
2/36
|
2.9%
1/34
|
|
Infections and infestations
INFLUENZA
|
5.6%
2/36
|
8.8%
3/34
|
|
Infections and infestations
MASTITIS
|
5.6%
2/36
|
0.00%
0/34
|
|
Infections and infestations
TOOTH ABSCESS
|
2.8%
1/36
|
5.9%
2/34
|
|
Infections and infestations
VAGINAL INFECTION
|
5.6%
2/36
|
0.00%
0/34
|
|
Infections and infestations
VULVOVAGINAL CANDIDIASIS
|
5.6%
2/36
|
0.00%
0/34
|
|
Injury, poisoning and procedural complications
RADIATION SKIN INJURY
|
0.00%
0/36
|
5.9%
2/34
|
|
Investigations
HEPATIC ENZYME INCREASED
|
2.8%
1/36
|
8.8%
3/34
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
5.6%
2/36
|
0.00%
0/34
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
61.1%
22/36
|
47.1%
16/34
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
11.1%
4/36
|
11.8%
4/34
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
33.3%
12/36
|
32.4%
11/34
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
5.6%
2/36
|
5.9%
2/34
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL STIFFNESS
|
5.6%
2/36
|
2.9%
1/34
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/36
|
14.7%
5/34
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
5.6%
2/36
|
2.9%
1/34
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
2.8%
1/36
|
5.9%
2/34
|
|
Musculoskeletal and connective tissue disorders
PAIN IN JAW
|
0.00%
0/36
|
5.9%
2/34
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
5.6%
2/36
|
0.00%
0/34
|
|
Nervous system disorders
HEADACHE
|
8.3%
3/36
|
17.6%
6/34
|
|
Nervous system disorders
MIGRAINE
|
2.8%
1/36
|
5.9%
2/34
|
|
Nervous system disorders
MOVEMENT DISORDER
|
8.3%
3/36
|
5.9%
2/34
|
|
Nervous system disorders
PARAESTHESIA
|
16.7%
6/36
|
11.8%
4/34
|
|
Psychiatric disorders
DEPRESSION
|
2.8%
1/36
|
14.7%
5/34
|
|
Psychiatric disorders
SLEEP DISORDER
|
19.4%
7/36
|
5.9%
2/34
|
|
Renal and urinary disorders
URGE INCONTINENCE
|
2.8%
1/36
|
5.9%
2/34
|
|
Reproductive system and breast disorders
MENOPAUSAL SYMPTOMS
|
38.9%
14/36
|
47.1%
16/34
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/36
|
5.9%
2/34
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
5.6%
2/36
|
2.9%
1/34
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
5.6%
2/36
|
0.00%
0/34
|
|
Vascular disorders
HOT FLUSH
|
55.6%
20/36
|
47.1%
16/34
|
|
Vascular disorders
HYPERTENSION
|
8.3%
3/36
|
5.9%
2/34
|
|
Vascular disorders
LYMPHOEDEMA
|
52.8%
19/36
|
32.4%
11/34
|
|
Vascular disorders
THROMBOSIS
|
5.6%
2/36
|
2.9%
1/34
|
Additional Information
Study Director
Novartis
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 or disclosure of trial results in their entirety
- Publication restrictions are in place
Restriction type: OTHER