Trial Outcomes & Findings for Zoledronic Acid for Osteoporosis in the Elderly (NCT NCT00558012)
NCT ID: NCT00558012
Last Updated: 2015-07-31
Results Overview
BMD is the bone mineral density of the lumbar spine and total hip measured using dual-energy xray absorptiometry (DXA) scan
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
181 participants
Primary outcome timeframe
Baseline, 12 months, 24 month
Results posted on
2015-07-31
Participant Flow
Participant milestones
| Measure |
Active Medication Group
One-time dose: Intravenous Zoledronic Acid 5.0 mg
Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once
|
Placebo
Placebo
One-time dose: Intravenous saline
|
|---|---|---|
|
Overall Study
STARTED
|
89
|
92
|
|
Overall Study
COMPLETED
|
64
|
74
|
|
Overall Study
NOT COMPLETED
|
25
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Zoledronic Acid for Osteoporosis in the Elderly
Baseline characteristics by cohort
| Measure |
Active Medication Group
n=89 Participants
One-time dose: Intravenous Zoledronic Acid 5.0 mg
Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once
|
Placebo
n=92 Participants
Placebo
Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once
|
Total
n=181 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
89 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
89 participants
n=5 Participants
|
92 participants
n=7 Participants
|
181 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 months, 24 monthPopulation: Number of patients that completed a DXA at 12 months. At 24 months 60 in active treatment group and 72 in placebo group completed a DXA.
BMD is the bone mineral density of the lumbar spine and total hip measured using dual-energy xray absorptiometry (DXA) scan
Outcome measures
| Measure |
Active Medication Group
n=75 Participants
One-time dose: Intravenous Zoledronic Acid 5.0 mg
Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once
|
Placebo
n=83 Participants
Placebo
Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once
|
|---|---|---|
|
Bone Mineral Density (BMD) of the Total Hip and Spine
Total Hip BMD at 24 months
|
2.6 Percent change
Standard Error 0.6
|
-1.5 Percent change
Standard Error 0.7
|
|
Bone Mineral Density (BMD) of the Total Hip and Spine
Total Hip BMD at 12 months
|
2.8 Percent change
Standard Error 0.5
|
-0.5 Percent change
Standard Error 0.4
|
|
Bone Mineral Density (BMD) of the Total Hip and Spine
Spine BMD at 24 months
|
4.5 Percent change
Standard Error 0.8
|
0.7 Percent change
Standard Error 0.5
|
|
Bone Mineral Density (BMD) of the Total Hip and Spine
Spine BMD at 12 months
|
3.0 Percent change
Standard Error 0.5
|
1.1 Percent change
Standard Error 0.5
|
Adverse Events
Active Medication Group
Serious events: 60 serious events
Other events: 87 other events
Deaths: 0 deaths
Placebo
Serious events: 55 serious events
Other events: 88 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active Medication Group
n=89 participants at risk
One-time dose: Intravenous Zoledronic Acid 5.0 mg
Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once
|
Placebo
n=92 participants at risk
Placebo
Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
3.4%
3/89 • 2 years
|
3.3%
3/92 • 2 years
|
|
Eye disorders
choroid melanoma
|
1.1%
1/89 • 2 years
|
0.00%
0/92 • 2 years
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
General disorders
Death
|
9.0%
8/89 • 2 years
|
3.3%
3/92 • 2 years
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
1.1%
1/89 • 2 years
|
0.00%
0/92 • 2 years
|
|
Infections and infestations
Bronchitis
|
3.4%
3/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
Investigations
Blood glucose increased
|
0.00%
0/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
1.1%
1/89 • 2 years
|
2.2%
2/92 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.2%
2/89 • 2 years
|
0.00%
0/92 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
Nervous system disorders
Cerebellar infarction
|
1.1%
1/89 • 2 years
|
0.00%
0/92 • 2 years
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
4.5%
4/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
Surgical and medical procedures
Arterial bypass operation
|
0.00%
0/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
Cardiac disorders
Cardiac failure congestive
|
6.7%
6/89 • 2 years
|
3.3%
3/92 • 2 years
|
|
Cardiac disorders
Chest pain
|
1.1%
1/89 • 2 years
|
7.6%
7/92 • 2 years
|
|
Cardiac disorders
Myocardial infarction
|
2.2%
2/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
Cardiac disorders
Oedema perepheral
|
1.1%
1/89 • 2 years
|
0.00%
0/92 • 2 years
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
1/89 • 2 years
|
0.00%
0/92 • 2 years
|
|
Gastrointestinal disorders
Clostridium difficile colitis
|
1.1%
1/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
1.1%
1/89 • 2 years
|
2.2%
2/92 • 2 years
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
Gastrointestinal disorders
Gastoenteritis
|
1.1%
1/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
3.4%
3/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
Gastrointestinal disorders
Gastriesophageal reflux disease
|
0.00%
0/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
1.1%
1/89 • 2 years
|
0.00%
0/92 • 2 years
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
Gastrointestinal disorders
Pancreatic mass
|
0.00%
0/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
Gastrointestinal disorders
Proctitis ulcerative
|
1.1%
1/89 • 2 years
|
0.00%
0/92 • 2 years
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/89 • 2 years
|
2.2%
2/92 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
1/89 • 2 years
|
0.00%
0/92 • 2 years
|
|
Infections and infestations
Herpes zoster
|
1.1%
1/89 • 2 years
|
0.00%
0/92 • 2 years
|
|
Infections and infestations
Pneumonia
|
9.0%
8/89 • 2 years
|
5.4%
5/92 • 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
4.5%
4/89 • 2 years
|
4.3%
4/92 • 2 years
|
|
Injury, poisoning and procedural complications
Head injury
|
1.1%
1/89 • 2 years
|
0.00%
0/92 • 2 years
|
|
Injury, poisoning and procedural complications
Post traumatic pain
|
0.00%
0/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
Investigations
Sepsis
|
0.00%
0/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Femur fracture
|
0.00%
0/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Fractured sacrum
|
0.00%
0/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
1.1%
1/89 • 2 years
|
0.00%
0/92 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Hip fracture
|
1.1%
1/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.2%
2/89 • 2 years
|
0.00%
0/92 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pubic rami fracture
|
1.1%
1/89 • 2 years
|
0.00%
0/92 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Tibia fracture
|
1.1%
1/89 • 2 years
|
0.00%
0/92 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
Nervous system disorders
Cerebrovascular accident
|
2.2%
2/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
Nervous system disorders
Confusional state
|
1.1%
1/89 • 2 years
|
0.00%
0/92 • 2 years
|
|
Nervous system disorders
Dementia Alzheimers type
|
0.00%
0/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
Nervous system disorders
Lethargy
|
1.1%
1/89 • 2 years
|
0.00%
0/92 • 2 years
|
|
Nervous system disorders
Loss of consciousness
|
1.1%
1/89 • 2 years
|
0.00%
0/92 • 2 years
|
|
Nervous system disorders
Mental impairment
|
3.4%
3/89 • 2 years
|
2.2%
2/92 • 2 years
|
|
Nervous system disorders
Relapsing-remitting multiple sclerosis
|
1.1%
1/89 • 2 years
|
0.00%
0/92 • 2 years
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
1.1%
1/89 • 2 years
|
0.00%
0/92 • 2 years
|
|
Nervous system disorders
Syncope
|
0.00%
0/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
Nervous system disorders
Transient ischemic attack
|
3.4%
3/89 • 2 years
|
4.3%
4/92 • 2 years
|
|
Nervous system disorders
Tremor
|
1.1%
1/89 • 2 years
|
0.00%
0/92 • 2 years
|
|
Renal and urinary disorders
Urinary tract infection
|
4.5%
4/89 • 2 years
|
4.3%
4/92 • 2 years
|
|
Renal and urinary disorders
Urosepsis
|
1.1%
1/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.1%
1/89 • 2 years
|
0.00%
0/92 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
4.5%
4/89 • 2 years
|
3.3%
3/92 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.2%
2/89 • 2 years
|
3.3%
3/92 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.1%
1/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.1%
1/89 • 2 years
|
0.00%
0/92 • 2 years
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
Surgical and medical procedures
Knee arthroplast
|
1.1%
1/89 • 2 years
|
2.2%
2/92 • 2 years
|
|
Surgical and medical procedures
Shoulder arthroplasty
|
0.00%
0/89 • 2 years
|
2.2%
2/92 • 2 years
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/89 • 2 years
|
2.2%
2/92 • 2 years
|
|
Vascular disorders
Colitis ischaemic
|
0.00%
0/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
Vascular disorders
Deep vein thrombosis
|
1.1%
1/89 • 2 years
|
0.00%
0/92 • 2 years
|
|
Vascular disorders
Essential hypertension
|
1.1%
1/89 • 2 years
|
0.00%
0/92 • 2 years
|
|
Vascular disorders
Hypertension
|
2.2%
2/89 • 2 years
|
0.00%
0/92 • 2 years
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
Vascular disorders
Labile blood pressure
|
1.1%
1/89 • 2 years
|
0.00%
0/92 • 2 years
|
|
Vascular disorders
Orthostatic hypotension
|
1.1%
1/89 • 2 years
|
0.00%
0/92 • 2 years
|
|
Vascular disorders
Pulmonary embolism
|
1.1%
1/89 • 2 years
|
0.00%
0/92 • 2 years
|
Other adverse events
| Measure |
Active Medication Group
n=89 participants at risk
One-time dose: Intravenous Zoledronic Acid 5.0 mg
Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once
|
Placebo
n=92 participants at risk
Placebo
Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
5.6%
5/89 • 2 years
|
5.4%
5/92 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
7.9%
7/89 • 2 years
|
13.0%
12/92 • 2 years
|
|
General disorders
Death
|
9.0%
8/89 • 2 years
|
3.3%
3/92 • 2 years
|
|
Infections and infestations
Bronchitis
|
6.7%
6/89 • 2 years
|
3.3%
3/92 • 2 years
|
|
Injury, poisoning and procedural complications
Contusion
|
5.6%
5/89 • 2 years
|
14.1%
13/92 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
5.6%
5/89 • 2 years
|
3.3%
3/92 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.5%
12/89 • 2 years
|
7.6%
7/92 • 2 years
|
|
Nervous system disorders
Headache
|
15.7%
14/89 • 2 years
|
8.7%
8/92 • 2 years
|
|
Renal and urinary disorders
Urinary tract infection
|
18.0%
16/89 • 2 years
|
21.7%
20/92 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.6%
5/89 • 2 years
|
7.6%
7/92 • 2 years
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
10.1%
9/89 • 2 years
|
7.6%
7/92 • 2 years
|
|
Surgical and medical procedures
Tooth extraction
|
4.5%
4/89 • 2 years
|
5.4%
5/92 • 2 years
|
|
Vascular disorders
Ecchymosis
|
1.1%
1/89 • 2 years
|
5.4%
5/92 • 2 years
|
|
Cardiac disorders
Cardiac failure congestive
|
9.0%
8/89 • 2 years
|
4.3%
4/92 • 2 years
|
|
Cardiac disorders
Chest pain
|
9.0%
8/89 • 2 years
|
13.0%
12/92 • 2 years
|
|
Cardiac disorders
Oedema peripheral
|
5.6%
5/89 • 2 years
|
5.4%
5/92 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
14.6%
13/89 • 2 years
|
7.6%
7/92 • 2 years
|
|
General disorders
Fatigue
|
27.0%
24/89 • 2 years
|
15.2%
14/92 • 2 years
|
|
General disorders
Influenza-like illness
|
6.7%
6/89 • 2 years
|
2.2%
2/92 • 2 years
|
|
General disorders
Pyrexia
|
9.0%
8/89 • 2 years
|
1.1%
1/92 • 2 years
|
|
Infections and infestations
Pneumonia
|
13.5%
12/89 • 2 years
|
9.8%
9/92 • 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
77.5%
69/89 • 2 years
|
58.7%
54/92 • 2 years
|
|
Injury, poisoning and procedural complications
Infusion site bruising
|
12.4%
11/89 • 2 years
|
13.0%
12/92 • 2 years
|
|
Injury, poisoning and procedural complications
Post traumatic pain
|
5.6%
5/89 • 2 years
|
5.4%
5/92 • 2 years
|
|
Injury, poisoning and procedural complications
Skin laceration
|
9.0%
8/89 • 2 years
|
10.9%
10/92 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.5%
4/89 • 2 years
|
5.4%
5/92 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.7%
6/89 • 2 years
|
0.00%
0/92 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.0%
8/89 • 2 years
|
6.5%
6/92 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.2%
10/89 • 2 years
|
7.6%
7/92 • 2 years
|
|
Nervous system disorders
Transient ischemic attack
|
3.4%
3/89 • 2 years
|
5.4%
5/92 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place