Trial Outcomes & Findings for Zoledronic Acid for Osteoporotic Fracture Prevention (ZEST II) (NCT NCT02589600)
NCT ID: NCT02589600
Last Updated: 2023-09-26
Results Overview
Number of fractures divided by number of person-years. Effectiveness of fracture reduction will be demonstrated by total non-traumatic incidental fractures (vertebral and nonvertebral \[identified by x-ray, CT, MRI, VFA imaging) except those viewed as severe trauma (fall from a height higher than a stool or chair or severe trauma other than a fall), cancer-related or fractures of the toes, finger or facial bones.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
310 participants
Primary outcome timeframe
3 years
Results posted on
2023-09-26
Participant Flow
Recruitment will occur during the first 2 years of the grant cycle and take place in the determined long term care facilities.
310 subjects were consented, randomized and received the study drug.
Participant milestones
| Measure |
Active Medication Group
Annual dose: intravenous zoledronic acid (Reclast) 5.0 mg; vitamin D (800 IU/daily) and calcium (approximately 1200 mg/daily, dietary + supplements)
Zoledronic acid: Annual intravenous 5.0 mg
vitamin D: 800 IU daily
calcium: approximately 1200 mg (dietary and supplement)
|
Placebo Group
Annual dose: intravenous saline; vitamin D (800 IU/daily and calcium (approximately 1200 mg/daily, dietary + supplements)
vitamin D: 800 IU daily
calcium: approximately 1200 mg (dietary and supplement)
Saline: Annual intravenous saline placebo
|
|---|---|---|
|
Overall Study
STARTED
|
154
|
156
|
|
Overall Study
COMPLETED
|
101
|
102
|
|
Overall Study
NOT COMPLETED
|
53
|
54
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Zoledronic Acid for Osteoporotic Fracture Prevention (ZEST II)
Baseline characteristics by cohort
| Measure |
Active Medication Group
n=154 Participants
Annual dose: intravenous zoledronic acid (Reclast) 5.0 mg; vitamin D (800 IU/daily) and calcium (approximately 1200 mg/daily, dietary + supplements)
Zoledronic acid: Annual intravenous 5.0 mg
vitamin D: 800 IU daily
calcium: approximately 1200 mg (dietary and supplement)
|
Placebo Group
n=156 Participants
Annual dose: intravenous saline; vitamin D (800 IU/daily and calcium (approximately 1200 mg/daily, dietary + supplements)
vitamin D: 800 IU daily
calcium: approximately 1200 mg (dietary and supplement)
Saline: Annual intravenous saline placebo
|
Total
n=310 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
|
154 Participants
n=5 Participants
|
156 Participants
n=7 Participants
|
310 Participants
n=5 Participants
|
|
Age, Continuous
|
81.3 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
79.9 years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
80.6 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
154 Participants
n=5 Participants
|
156 Participants
n=7 Participants
|
310 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
151 Participants
n=5 Participants
|
155 Participants
n=7 Participants
|
306 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
142 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
288 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
154 participants
n=5 Participants
|
156 participants
n=7 Participants
|
310 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: Women age 65 years and older
Number of fractures divided by number of person-years. Effectiveness of fracture reduction will be demonstrated by total non-traumatic incidental fractures (vertebral and nonvertebral \[identified by x-ray, CT, MRI, VFA imaging) except those viewed as severe trauma (fall from a height higher than a stool or chair or severe trauma other than a fall), cancer-related or fractures of the toes, finger or facial bones.
Outcome measures
| Measure |
Active Medication Group
n=154 Participants
Annual dose: intravenous zoledronic acid (Reclast) 5.0 mg; vitamin D (800 IU/daily) and calcium (approximately 1200 mg/daily, dietary + supplements)
Zoledronic acid: Annual intravenous 5.0 mg
vitamin D: 800 IU daily
calcium: approximately 1200 mg (dietary and supplement)
|
Placebo Group
n=156 Participants
Annual dose: intravenous saline; vitamin D (800 IU/daily and calcium (approximately 1200 mg/daily, dietary + supplements)
vitamin D: 800 IU daily
calcium: approximately 1200 mg (dietary and supplement)
Saline: Annual intravenous saline placebo
|
|---|---|---|
|
Non-traumatic Incidental Fractures (Vertebral and Nonvertebral [Identified by X-ray, CT, MRI, VFA Imaging] Per Person-year)
|
1.06093 Fractures per person-year
|
1.01563 Fractures per person-year
|
Adverse Events
Active Medication Group
Serious events: 73 serious events
Other events: 131 other events
Deaths: 13 deaths
Placebo Group
Serious events: 80 serious events
Other events: 130 other events
Deaths: 19 deaths
Serious adverse events
| Measure |
Active Medication Group
n=154 participants at risk
Annual dose: intravenous zoledronic acid (Reclast) 5.0 mg; vitamin D (800 IU/daily) and calcium (approximately 1200 mg/daily, dietary + supplements)
Zoledronic acid: Annual intravenous 5.0 mg
vitamin D: 800 IU daily
calcium: approximately 1200 mg (dietary and supplement)
|
Placebo Group
n=156 participants at risk
Annual dose: intravenous saline; vitamin D (800 IU/daily and calcium (approximately 1200 mg/daily, dietary + supplements)
vitamin D: 800 IU daily
calcium: approximately 1200 mg (dietary and supplement)
Saline: Annual intravenous saline placebo
|
|---|---|---|
|
Surgical and medical procedures
Implantable defibrillator insertion
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.65%
1/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.65%
1/154 • Up to three years.
|
1.9%
3/156 • Up to three years.
|
|
Blood and lymphatic system disorders
Anemia of chronic disease
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.65%
1/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Cardiac disorders
Atrial fibrillation
|
3.2%
5/154 • Up to three years.
|
3.2%
5/156 • Up to three years.
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Cardiac disorders
Cardiac failure
|
0.65%
1/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Cardiac disorders
Cardiac failure congestive
|
3.2%
5/154 • Up to three years.
|
3.2%
5/156 • Up to three years.
|
|
Cardiac disorders
Chest pain
|
5.2%
8/154 • Up to three years.
|
4.5%
7/156 • Up to three years.
|
|
Cardiac disorders
Edema peripheral
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Cardiac disorders
Fluid overload
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Cardiac disorders
Myocardial infarction
|
0.65%
1/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Ear and labyrinth disorders
Vertigo
|
1.9%
3/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Endocrine disorders
Hypoglycemia
|
1.3%
2/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Eye disorders
Blurred vision
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Eye disorders
Microvascular cranial nerve palsy
|
0.65%
1/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Eye disorders
Ulcerative keratitis
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
2/154 • Up to three years.
|
1.3%
2/156 • Up to three years.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Gastrointestinal disorders
Anal Spasm
|
0.65%
1/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Gastrointestinal disorders
Colitis
|
1.3%
2/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Gastrointestinal disorders
Constipation
|
0.65%
1/154 • Up to three years.
|
1.3%
2/156 • Up to three years.
|
|
Gastrointestinal disorders
Diarrhea
|
0.65%
1/154 • Up to three years.
|
1.9%
3/156 • Up to three years.
|
|
Gastrointestinal disorders
Diarrhea hemorrhagic
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/154 • Up to three years.
|
2.6%
4/156 • Up to three years.
|
|
Gastrointestinal disorders
Esophagitis
|
0.65%
1/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.65%
1/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.65%
1/154 • Up to three years.
|
1.3%
2/156 • Up to three years.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
3.2%
5/154 • Up to three years.
|
3.8%
6/156 • Up to three years.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.65%
1/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Gastrointestinal disorders
Nausea
|
0.65%
1/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Gastrointestinal disorders
Pancreatitis
|
1.3%
2/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
2.6%
4/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
General disorders
Death
|
8.4%
13/154 • Up to three years.
|
12.2%
19/156 • Up to three years.
|
|
General disorders
Gait disturbance
|
0.65%
1/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
General disorders
Influenza like illness
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
General disorders
Pyrexia
|
0.65%
1/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
General disorders
Weakness
|
3.2%
5/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.65%
1/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Infections and infestations
Bacteremia
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Infections and infestations
Bronchitis
|
0.65%
1/154 • Up to three years.
|
1.9%
3/156 • Up to three years.
|
|
Infections and infestations
COVID-19
|
0.65%
1/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Infections and infestations
Influenza
|
0.65%
1/154 • Up to three years.
|
1.3%
2/156 • Up to three years.
|
|
Infections and infestations
Pneumonia
|
2.6%
4/154 • Up to three years.
|
2.6%
4/156 • Up to three years.
|
|
Infections and infestations
Sepsis
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Infections and infestations
Wound infection
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.65%
1/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Injury, poisoning and procedural complications
Fall
|
5.8%
9/154 • Up to three years.
|
4.5%
7/156 • Up to three years.
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Injury, poisoning and procedural complications
Subdural Hematoma
|
2.6%
4/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.65%
1/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.65%
1/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.65%
1/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.65%
1/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Musculoskeletal and connective tissue disorders
Ankle fracture
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/154 • Up to three years.
|
1.3%
2/156 • Up to three years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.3%
2/154 • Up to three years.
|
2.6%
4/156 • Up to three years.
|
|
Musculoskeletal and connective tissue disorders
Fractured sacrum
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Musculoskeletal and connective tissue disorders
Hip fracture
|
3.9%
6/154 • Up to three years.
|
2.6%
4/156 • Up to three years.
|
|
Musculoskeletal and connective tissue disorders
Lumbar vertebral fracture
|
0.65%
1/154 • Up to three years.
|
1.9%
3/156 • Up to three years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.65%
1/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Musculoskeletal and connective tissue disorders
Patella Fracture
|
0.65%
1/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Musculoskeletal and connective tissue disorders
Pelvic Fracture
|
1.3%
2/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Musculoskeletal and connective tissue disorders
Pubic rami fracture
|
1.3%
2/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Musculoskeletal and connective tissue disorders
Radius fracture
|
1.3%
2/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
1.3%
2/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Musculoskeletal and connective tissue disorders
Rib fracture
|
0.65%
1/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Musculoskeletal and connective tissue disorders
Thoracic vertebral fracture
|
0.65%
1/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Musculoskeletal and connective tissue disorders
Wrist fracture
|
0.65%
1/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.65%
1/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
0.65%
1/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
1.9%
3/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-cell lymphoma
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional Cell Carcinoma
|
0.65%
1/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Nervous system disorders
Aphasia
|
0.65%
1/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Nervous system disorders
Confusional state
|
1.3%
2/154 • Up to three years.
|
1.3%
2/156 • Up to three years.
|
|
Nervous system disorders
Dizziness
|
1.3%
2/154 • Up to three years.
|
1.9%
3/156 • Up to three years.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Nervous system disorders
Headache
|
0.65%
1/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Nervous system disorders
Ischemic cerebral infarction
|
0.65%
1/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.65%
1/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Nervous system disorders
Normal Pressure Hydrocephalus
|
0.65%
1/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Nervous system disorders
Subarachnoid hemorrhage
|
0.65%
1/154 • Up to three years.
|
1.3%
2/156 • Up to three years.
|
|
Nervous system disorders
Syncope
|
3.9%
6/154 • Up to three years.
|
1.3%
2/156 • Up to three years.
|
|
Nervous system disorders
Transient ischemic attack
|
2.6%
4/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Nervous system disorders
Vertigo positional
|
0.65%
1/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Psychiatric disorders
Acute Confusional State
|
0.65%
1/154 • Up to three years.
|
2.6%
4/156 • Up to three years.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Renal and urinary disorders
Urinary tract infection
|
2.6%
4/154 • Up to three years.
|
5.1%
8/156 • Up to three years.
|
|
Respiratory, thoracic and mediastinal disorders
Adenoviral upper respiratory infection
|
0.65%
1/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration Pneumonia
|
0.65%
1/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.3%
2/154 • Up to three years.
|
3.2%
5/156 • Up to three years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.9%
3/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Respiratory, thoracic and mediastinal disorders
Lobar Pneumonia
|
0.65%
1/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.65%
1/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.65%
1/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.9%
3/154 • Up to three years.
|
2.6%
4/156 • Up to three years.
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
1.9%
3/154 • Up to three years.
|
1.9%
3/156 • Up to three years.
|
|
Surgical and medical procedures
Aortic Valve replacement
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Surgical and medical procedures
Colectomy
|
0.65%
1/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.65%
1/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Surgical and medical procedures
Hernia hiatus repair
|
0.65%
1/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Surgical and medical procedures
Hip arthroplasty
|
2.6%
4/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Surgical and medical procedures
Mastectomy
|
1.3%
2/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Surgical and medical procedures
Nephrectomy
|
0.65%
1/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Surgical and medical procedures
Oesophagogastric fundoplasty
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Surgical and medical procedures
Open reduction of fracture
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Surgical and medical procedures
Rectal Prolapse Repair
|
0.65%
1/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Surgical and medical procedures
Shoulder arthroplasty
|
0.00%
0/154 • Up to three years.
|
1.9%
3/156 • Up to three years.
|
|
Surgical and medical procedures
Spinal laminectomy
|
1.3%
2/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Surgical and medical procedures
Thromboembolectomy
|
0.65%
1/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Surgical and medical procedures
Vaginal fistula repair
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Surgical and medical procedures
skin graft
|
0.00%
0/154 • Up to three years.
|
1.3%
2/156 • Up to three years.
|
|
Vascular disorders
Aortic Dissection
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Vascular disorders
Aortic Stenosis
|
0.65%
1/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Vascular disorders
Hematoma
|
0.65%
1/154 • Up to three years.
|
0.00%
0/156 • Up to three years.
|
|
Vascular disorders
Lymphedemas
|
0.65%
1/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
|
Vascular disorders
Hypertension
|
0.65%
1/154 • Up to three years.
|
0.64%
1/156 • Up to three years.
|
Other adverse events
| Measure |
Active Medication Group
n=154 participants at risk
Annual dose: intravenous zoledronic acid (Reclast) 5.0 mg; vitamin D (800 IU/daily) and calcium (approximately 1200 mg/daily, dietary + supplements)
Zoledronic acid: Annual intravenous 5.0 mg
vitamin D: 800 IU daily
calcium: approximately 1200 mg (dietary and supplement)
|
Placebo Group
n=156 participants at risk
Annual dose: intravenous saline; vitamin D (800 IU/daily and calcium (approximately 1200 mg/daily, dietary + supplements)
vitamin D: 800 IU daily
calcium: approximately 1200 mg (dietary and supplement)
Saline: Annual intravenous saline placebo
|
|---|---|---|
|
Cardiac disorders
Chest pain
|
5.2%
8/154 • Up to three years.
|
4.5%
7/156 • Up to three years.
|
|
Injury, poisoning and procedural complications
Fall
|
38.3%
59/154 • Up to three years.
|
37.8%
59/156 • Up to three years.
|
|
Renal and urinary disorders
Urinary tract infection
|
10.4%
16/154 • Up to three years.
|
10.9%
17/156 • Up to three years.
|
|
Cardiac disorders
Atrial fibrillation
|
4.5%
7/154 • Up to three years.
|
5.1%
8/156 • Up to three years.
|
|
Gastrointestinal disorders
Diarrhea
|
9.7%
15/154 • Up to three years.
|
11.5%
18/156 • Up to three years.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
22/154 • Up to three years.
|
9.0%
14/156 • Up to three years.
|
|
Gastrointestinal disorders
Vomiting
|
5.8%
9/154 • Up to three years.
|
1.9%
3/156 • Up to three years.
|
|
General disorders
Fatigue
|
9.7%
15/154 • Up to three years.
|
6.4%
10/156 • Up to three years.
|
|
General disorders
Influenza like illness
|
14.3%
22/154 • Up to three years.
|
5.8%
9/156 • Up to three years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
14/154 • Up to three years.
|
9.0%
14/156 • Up to three years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.4%
13/154 • Up to three years.
|
7.1%
11/156 • Up to three years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.1%
31/154 • Up to three years.
|
10.9%
17/156 • Up to three years.
|
|
Nervous system disorders
Dizziness
|
1.9%
3/154 • Up to three years.
|
8.3%
13/156 • Up to three years.
|
|
Nervous system disorders
Headache
|
19.5%
30/154 • Up to three years.
|
11.5%
18/156 • Up to three years.
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
5.2%
8/154 • Up to three years.
|
2.6%
4/156 • Up to three years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place