Trial Outcomes & Findings for A Study of Zoledronic Acid in the Prevention of Cancer Therapy-induced Bone Loss (NCT NCT00333229)
NCT ID: NCT00333229
Last Updated: 2014-11-25
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
11 participants
Primary outcome timeframe
24 months
Results posted on
2014-11-25
Participant Flow
Participant milestones
| Measure |
Zoledronic Acid
Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
|
Placebo
Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
|
Overall Study
COMPLETED
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Zoledronic Acid
Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
|
Placebo
Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
Baseline Characteristics
A Study of Zoledronic Acid in the Prevention of Cancer Therapy-induced Bone Loss
Baseline characteristics by cohort
| Measure |
Zoledronic Acid
n=6 Participants
Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
|
Placebo
n=5 Participants
Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.2 Years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
43.2 Years
STANDARD_DEVIATION 2.6 • n=7 Participants
|
42.1 Years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 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: 24 monthsPopulation: Analysis was not completed as study was not adequately powered due to premature study termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
Outcome data not reported
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Zoledronic Acid
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=5 participants at risk
Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
|
Zoledronic Acid
n=6 participants at risk
Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
|
|---|---|---|
|
Eye disorders
VISUAL IMPAIRMENT
|
20.0%
1/5
|
0.00%
0/6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BENIGN BREAST NEOPLASM
|
0.00%
0/5
|
16.7%
1/6
|
|
Nervous system disorders
HEADACHE
|
20.0%
1/5
|
0.00%
0/6
|
Other adverse events
| Measure |
Placebo
n=5 participants at risk
Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
|
Zoledronic Acid
n=6 participants at risk
Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
|
|---|---|---|
|
Ear and labyrinth disorders
TINNITUS
|
20.0%
1/5
|
0.00%
0/6
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/5
|
16.7%
1/6
|
|
Endocrine disorders
AUTOIMMUNE THYROIDITIS
|
20.0%
1/5
|
0.00%
0/6
|
|
Eye disorders
DRY EYE
|
20.0%
1/5
|
0.00%
0/6
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
20.0%
1/5
|
0.00%
0/6
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/5
|
16.7%
1/6
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/5
|
16.7%
1/6
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
20.0%
1/5
|
0.00%
0/6
|
|
Gastrointestinal disorders
NAUSEA
|
40.0%
2/5
|
33.3%
2/6
|
|
General disorders
ASTHENIA
|
20.0%
1/5
|
0.00%
0/6
|
|
General disorders
CHEST PAIN
|
0.00%
0/5
|
16.7%
1/6
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.00%
0/5
|
16.7%
1/6
|
|
General disorders
MUCOSAL DRYNESS
|
20.0%
1/5
|
0.00%
0/6
|
|
General disorders
PAIN
|
20.0%
1/5
|
16.7%
1/6
|
|
Hepatobiliary disorders
HEPATIC STEATOSIS
|
20.0%
1/5
|
0.00%
0/6
|
|
Infections and infestations
FOLLICULITIS
|
20.0%
1/5
|
0.00%
0/6
|
|
Infections and infestations
FURUNCLE
|
0.00%
0/5
|
16.7%
1/6
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/5
|
33.3%
2/6
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.00%
0/5
|
16.7%
1/6
|
|
Infections and infestations
ORAL HERPES
|
0.00%
0/5
|
16.7%
1/6
|
|
Investigations
HEPATIC ENZYME INCREASED
|
40.0%
2/5
|
16.7%
1/6
|
|
Metabolism and nutrition disorders
HYPERCHOLESTEROLAEMIA
|
20.0%
1/5
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/5
|
16.7%
1/6
|
|
Metabolism and nutrition disorders
TYPE 2 DIABETES MELLITUS
|
20.0%
1/5
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
60.0%
3/5
|
50.0%
3/6
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
20.0%
1/5
|
16.7%
1/6
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
40.0%
2/5
|
50.0%
3/6
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
20.0%
1/5
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
MYOSCLEROSIS
|
0.00%
0/5
|
16.7%
1/6
|
|
Musculoskeletal and connective tissue disorders
OSTEOCHONDROSIS
|
20.0%
1/5
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/5
|
16.7%
1/6
|
|
Musculoskeletal and connective tissue disorders
RHEUMATIC FEVER
|
20.0%
1/5
|
0.00%
0/6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MELANOCYTIC NAEVUS
|
0.00%
0/5
|
16.7%
1/6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
THYROID NEOPLASM
|
0.00%
0/5
|
16.7%
1/6
|
|
Nervous system disorders
AMNESIA
|
20.0%
1/5
|
0.00%
0/6
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/5
|
16.7%
1/6
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
0.00%
0/5
|
16.7%
1/6
|
|
Nervous system disorders
PARAESTHESIA
|
60.0%
3/5
|
33.3%
2/6
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/5
|
16.7%
1/6
|
|
Psychiatric disorders
CONVERSION DISORDER
|
20.0%
1/5
|
0.00%
0/6
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/5
|
16.7%
1/6
|
|
Psychiatric disorders
SLEEP DISORDER
|
40.0%
2/5
|
0.00%
0/6
|
|
Reproductive system and breast disorders
MENOPAUSAL SYMPTOMS
|
20.0%
1/5
|
16.7%
1/6
|
|
Reproductive system and breast disorders
POSTMENOPAUSAL HAEMORRHAGE
|
0.00%
0/5
|
16.7%
1/6
|
|
Reproductive system and breast disorders
UTERINE POLYP
|
0.00%
0/5
|
16.7%
1/6
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/5
|
16.7%
1/6
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
20.0%
1/5
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/5
|
16.7%
1/6
|
|
Skin and subcutaneous tissue disorders
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS
|
0.00%
0/5
|
16.7%
1/6
|
|
Vascular disorders
HOT FLUSH
|
40.0%
2/5
|
33.3%
2/6
|
|
Vascular disorders
LYMPHOEDEMA
|
60.0%
3/5
|
83.3%
5/6
|
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 pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER