Trial Outcomes & Findings for Safety/Efficacy of Zoledronic Acid and Alendronate on Bone Metabolism in Postmenopausal Women With Osteoporosis (NCT NCT00404820)
NCT ID: NCT00404820
Last Updated: 2011-07-01
Results Overview
The level of bone activity as measured by NTx over the course of 12 months was assessed using the standardized area under the curve. Blood samples were collected after an overnight fast of at least 8 hours between 7:00 and 11:00 AM at Screening and Months 1.5, 3, 6, 9, and 12 months after baseline. Serum was analyzed at a central lab using commercially available ELISA kits. Standardized AUC was calculated by the AUC divided by the number of days the patient participated in the study.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
604 participants
Primary outcome timeframe
Screening to end of study (Month 12)
Results posted on
2011-07-01
Participant Flow
The study was conducted in Germany; first patient enrolled October 2006 and completed December 2008.
Participant milestones
| Measure |
Zoledronic Acid 5 mg
Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
|
Alendronate 70 mg
Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
|
|---|---|---|
|
Overall Study
STARTED
|
408
|
196
|
|
Overall Study
Started Treatment
|
408
|
194
|
|
Overall Study
COMPLETED
|
389
|
172
|
|
Overall Study
NOT COMPLETED
|
19
|
24
|
Reasons for withdrawal
| Measure |
Zoledronic Acid 5 mg
Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
|
Alendronate 70 mg
Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
16
|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
|
Overall Study
Lost to Follow-up
|
7
|
3
|
|
Overall Study
Administrative problems
|
2
|
0
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Other
|
0
|
2
|
Baseline Characteristics
Safety/Efficacy of Zoledronic Acid and Alendronate on Bone Metabolism in Postmenopausal Women With Osteoporosis
Baseline characteristics by cohort
| Measure |
Zoledronic Acid 5 mg
n=408 Participants
Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
|
Alendronate 70 mg
n=194 Participants
Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
|
Total
n=602 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
67.6 years
STANDARD_DEVIATION 8.1 • n=93 Participants
|
68.2 years
STANDARD_DEVIATION 7.9 • n=4 Participants
|
67.8 years
STANDARD_DEVIATION 8.0 • n=27 Participants
|
|
Sex: Female, Male
Female
|
408 Participants
n=93 Participants
|
194 Participants
n=4 Participants
|
602 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Screening to end of study (Month 12)Population: Intent-to-treat sample (ITT) population: All patients who received at least 1 dose of study medication and who had at least 1 post-baseline determination of cross-linked N-telopeptide of type I collagen (NTx) level.
The level of bone activity as measured by NTx over the course of 12 months was assessed using the standardized area under the curve. Blood samples were collected after an overnight fast of at least 8 hours between 7:00 and 11:00 AM at Screening and Months 1.5, 3, 6, 9, and 12 months after baseline. Serum was analyzed at a central lab using commercially available ELISA kits. Standardized AUC was calculated by the AUC divided by the number of days the patient participated in the study.
Outcome measures
| Measure |
Zoledronic Acid 5 mg
n=408 Participants
Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
|
Alendronate 70 mg
n=191 Participants
Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
|
|---|---|---|
|
Change of Cross-linked N-telopeptide of Type I Collagen (NTx) Level Assessed as Standardized Area Under the Curve From Screening to Month 12 in the Intent-to-Treat Population
|
0.282 ng/ml
Standard Deviation 0.195
|
0.270 ng/ml
Standard Deviation 0.266
|
PRIMARY outcome
Timeframe: Screening to end of study (Month 12)Population: Per Protocol population: All intent-to-treat patients who did not show major deviations from the protocol procedures that may have had an impact on the study outcome.
The level of bone activity as measured by NTx over the course of 12 months was assessed using the standardized area under the curve. Blood samples were collected after an overnight fast of at least 8 hours between 7:00 and 11:00 AM at Screening and Months 1.5, 3, 6, 9, and 12 months after baseline. Serum was analyzed at a central lab using commercially available ELISA kits. Standardized AUC was calculated by the AUC divided by the number of days the patient participated in the study.
Outcome measures
| Measure |
Zoledronic Acid 5 mg
n=349 Participants
Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
|
Alendronate 70 mg
n=146 Participants
Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
|
|---|---|---|
|
Change of Cross-linked N-telopeptide of Type I Collagen (NTx) Level Assessed as Standardized Area Under the Curve From Screening to Month 12 in the Per Protocol Population
|
0.293 ng/ml
Standard Deviation 0.199
|
0.294 ng/ml
Standard Deviation 0.175
|
SECONDARY outcome
Timeframe: Screening to end of study (Month 12)Population: Intent-to-treat sample (ITT) population: All patients who received at least 1 dose of study medication and who had at least 1 post-baseline determination of cross-linked N-telopeptide of type I collagen (NTx) level.
The level of bone activity as measured by P1NP over the course of 12 months was assessed using the standardized area under the curve. Blood samples were collected after an overnight fast of at least 8 hours between 7:00 and 11:00 AM at Screening and Months 1.5, 3, 6, 9, and 12 months after baseline. Serum was analyzed at a central lab using commercially available ELISA kits. Standardized AUC was calculated by the AUC divided by the number of days the patient participated in the study.
Outcome measures
| Measure |
Zoledronic Acid 5 mg
n=408 Participants
Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
|
Alendronate 70 mg
n=191 Participants
Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
|
|---|---|---|
|
Change of Procollagen Type I Nitrogenous Propeptide (P1NP) Level Assessed as Standardized Area Under the Curve From Screening to Month 12
|
28.2 ng/ml
Standard Deviation 23.0
|
25.5 ng/ml
Standard Deviation 17.6
|
SECONDARY outcome
Timeframe: Baseline to end of study (Month 12)Population: Intent-to-treat sample (ITT) population: All patients who received at least 1 dose of study medication and who had at least 1 post-baseline determination of cross-linked N-telopeptide of type I collagen (NTx) level.
The Qualeffo-41 QoL questionnaire was completed by the patient at Baseline and at Month 12. The questionnaire includes 41 questions covering 7 domains (pain, physical function and activities of daily living, physical function and jobs around the house, physical function and mobility, leisure and social activities, general health perception, mental function). Scores on each question range from 1 to 3, 4, or 5. The total score summed over all questions ranges from 41-205 points; the lower the score the higher the quality of life. A negative change score indicates improvement.
Outcome measures
| Measure |
Zoledronic Acid 5 mg
n=408 Participants
Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
|
Alendronate 70 mg
n=191 Participants
Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
|
|---|---|---|
|
Change in the Qualeffo-41 Quality of Life (QoL) Questionnaire Score From Baseline to Month 12
|
-1.2 Units on a scale
Standard Deviation 8.8
|
-0.6 Units on a scale
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: Baseline to end of study (Month 12)Population: Intent-to-treat sample (ITT) population: All patients who received at least 1 dose of study medication and who had at least 1 post-baseline determination of cross-linked N-telopeptide of type I collagen (NTx) level.
A diagnosis of clinical fracture was based on physical examination findings, ie, swelling, tenderness, limited movement, pain.
Outcome measures
| Measure |
Zoledronic Acid 5 mg
n=408 Participants
Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
|
Alendronate 70 mg
n=191 Participants
Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
|
|---|---|---|
|
Number of Patients With a Clinical Fracture From Baseline to Month 12
|
10 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline to end of study (Month 12)Population: Intent-to-treat sample (ITT) population: All patients who received at least 1 dose of study medication and who had at least 1 post-baseline determination of cross-linked N-telopeptide of type I collagen (NTx) level.
Body height was measured at Baseline and at the end of the study (Month 12) and the change in height calculated.
Outcome measures
| Measure |
Zoledronic Acid 5 mg
n=408 Participants
Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
|
Alendronate 70 mg
n=191 Participants
Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
|
|---|---|---|
|
Change in Body Height From Baseline to Month 12
|
-0.1 cm
Standard Deviation 1.0
|
0.0 cm
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Month 12Population: Intent-to-treat sample (ITT) population: All patients who received at least 1 dose of study medication and who had at least 1 post-baseline determination of cross-linked N-telopeptide of type I collagen (NTx) level.
Patients were administered a questionnaire at the end of the study in which they were asked which type of therapy, weekly oral or yearly iv, they preferred.
Outcome measures
| Measure |
Zoledronic Acid 5 mg
n=408 Participants
Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
|
Alendronate 70 mg
n=191 Participants
Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
|
|---|---|---|
|
Therapy Preference at End of Study (Month 12)
No data available
|
30 Participants
|
16 Participants
|
|
Therapy Preference at End of Study (Month 12)
Yearly iv
|
330 Participants
|
82 Participants
|
|
Therapy Preference at End of Study (Month 12)
Weekly oral
|
48 Participants
|
93 Participants
|
Adverse Events
Zoledronic Acid 5 mg
Serious events: 43 serious events
Other events: 267 other events
Deaths: 0 deaths
Alendronate 70 mg
Serious events: 21 serious events
Other events: 94 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Zoledronic Acid 5 mg
n=408 participants at risk
Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
|
Alendronate 70 mg
n=194 participants at risk
Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/408
|
0.52%
1/194
|
|
Cardiac disorders
Atrial fibrillation
|
0.25%
1/408
|
0.00%
0/194
|
|
Cardiac disorders
Atrial flutter
|
0.25%
1/408
|
0.00%
0/194
|
|
Cardiac disorders
Bundle branch block left
|
0.25%
1/408
|
0.00%
0/194
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.25%
1/408
|
0.00%
0/194
|
|
Cardiac disorders
Myocardial infarction
|
0.25%
1/408
|
0.52%
1/194
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/408
|
0.52%
1/194
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/408
|
0.52%
1/194
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.25%
1/408
|
0.00%
0/194
|
|
Endocrine disorders
Goitre
|
0.25%
1/408
|
0.00%
0/194
|
|
Eye disorders
Visual disturbance
|
0.25%
1/408
|
0.00%
0/194
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/408
|
0.52%
1/194
|
|
Gastrointestinal disorders
Dyspepsia
|
0.25%
1/408
|
0.00%
0/194
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.25%
1/408
|
0.00%
0/194
|
|
Gastrointestinal disorders
Vomiting
|
0.25%
1/408
|
0.00%
0/194
|
|
General disorders
Chest pain
|
0.25%
1/408
|
0.52%
1/194
|
|
Hepatobiliary disorders
Bile duct stone
|
0.25%
1/408
|
0.00%
0/194
|
|
Hepatobiliary disorders
Biliary colic
|
0.25%
1/408
|
0.00%
0/194
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/408
|
0.52%
1/194
|
|
Hepatobiliary disorders
Cholestasis
|
0.25%
1/408
|
0.00%
0/194
|
|
Infections and infestations
Gastrointestinal infection
|
0.25%
1/408
|
0.00%
0/194
|
|
Infections and infestations
Herpes zoster
|
0.25%
1/408
|
0.00%
0/194
|
|
Infections and infestations
Pneumonia
|
0.49%
2/408
|
0.00%
0/194
|
|
Injury, poisoning and procedural complications
Concussion
|
0.25%
1/408
|
0.00%
0/194
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.25%
1/408
|
0.00%
0/194
|
|
Injury, poisoning and procedural complications
Fall
|
0.25%
1/408
|
0.52%
1/194
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/408
|
0.52%
1/194
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.25%
1/408
|
0.00%
0/194
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.25%
1/408
|
0.00%
0/194
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.49%
2/408
|
0.00%
0/194
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/408
|
0.52%
1/194
|
|
Investigations
C-Reactive protein increased
|
0.25%
1/408
|
0.00%
0/194
|
|
Metabolism and nutrition disorders
Dehydration
|
0.25%
1/408
|
0.00%
0/194
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.25%
1/408
|
0.00%
0/194
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.25%
1/408
|
0.00%
0/194
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/408
|
0.52%
1/194
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.25%
1/408
|
0.00%
0/194
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/408
|
0.52%
1/194
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.25%
1/408
|
0.52%
1/194
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.49%
2/408
|
0.00%
0/194
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.25%
1/408
|
0.00%
0/194
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.25%
1/408
|
0.00%
0/194
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/408
|
1.5%
3/194
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/408
|
0.52%
1/194
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.25%
1/408
|
0.00%
0/194
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.25%
1/408
|
0.00%
0/194
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.25%
1/408
|
0.00%
0/194
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.25%
1/408
|
0.00%
0/194
|
|
Nervous system disorders
Cerebrovascular vascular accident
|
0.25%
1/408
|
0.00%
0/194
|
|
Nervous system disorders
Dizziness
|
0.25%
1/408
|
0.00%
0/194
|
|
Nervous system disorders
Facial palsy
|
0.25%
1/408
|
0.00%
0/194
|
|
Nervous system disorders
Headache
|
0.25%
1/408
|
0.00%
0/194
|
|
Nervous system disorders
Lo of consciousness
|
0.25%
1/408
|
0.00%
0/194
|
|
Nervous system disorders
Monoplegia
|
0.25%
1/408
|
0.00%
0/194
|
|
Nervous system disorders
Presenile dementia
|
0.25%
1/408
|
0.00%
0/194
|
|
Nervous system disorders
Syncope
|
0.25%
1/408
|
1.0%
2/194
|
|
Nervous system disorders
Transient ischaemic attack
|
0.49%
2/408
|
0.00%
0/194
|
|
Pregnancy, puerperium and perinatal conditions
Postpartum haemorrhage
|
0.00%
0/408
|
0.52%
1/194
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.25%
1/408
|
0.00%
0/194
|
|
Reproductive system and breast disorders
Uterine cyst
|
0.25%
1/408
|
0.00%
0/194
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.25%
1/408
|
0.00%
0/194
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.25%
1/408
|
0.00%
0/194
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.74%
3/408
|
0.00%
0/194
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.25%
1/408
|
0.00%
0/194
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.25%
1/408
|
0.00%
0/194
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/408
|
0.52%
1/194
|
|
Surgical and medical procedures
Arterial bypass operation
|
0.00%
0/408
|
0.52%
1/194
|
|
Vascular disorders
Arterial occlusive disease
|
0.25%
1/408
|
0.00%
0/194
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/408
|
1.5%
3/194
|
|
Vascular disorders
Femoral artery occlusion
|
0.00%
0/408
|
0.52%
1/194
|
|
Vascular disorders
Hypertensive crisis
|
0.25%
1/408
|
1.0%
2/194
|
Other adverse events
| Measure |
Zoledronic Acid 5 mg
n=408 participants at risk
Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
|
Alendronate 70 mg
n=194 participants at risk
Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.9%
12/408
|
6.7%
13/194
|
|
Gastrointestinal disorders
Constipation
|
2.2%
9/408
|
5.2%
10/194
|
|
Gastrointestinal disorders
Diarrhoea
|
2.2%
9/408
|
5.2%
10/194
|
|
Gastrointestinal disorders
Dyspepsia
|
0.74%
3/408
|
7.2%
14/194
|
|
Gastrointestinal disorders
Nausea
|
5.6%
23/408
|
5.7%
11/194
|
|
General disorders
Fatigue
|
5.9%
24/408
|
2.1%
4/194
|
|
General disorders
Influenza like illness
|
32.4%
132/408
|
2.6%
5/194
|
|
General disorders
Pyrexia
|
5.1%
21/408
|
1.0%
2/194
|
|
Infections and infestations
Nasopharyngitis
|
6.4%
26/408
|
11.9%
23/194
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.5%
55/408
|
10.8%
21/194
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.7%
52/408
|
10.3%
20/194
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.6%
23/408
|
3.6%
7/194
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.4%
30/408
|
2.6%
5/194
|
|
Nervous system disorders
Headache
|
10.5%
43/408
|
4.1%
8/194
|
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 (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER