Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 23 of 28 for:    multiple sclerosis | vitamin D

Zoledronic Acid in MS-patients With Osteoporosis (EXALT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01166178
Recruitment Status : Terminated
First Posted : July 20, 2010
Results First Posted : November 26, 2013
Last Update Posted : November 26, 2013
Sponsor:
Information provided by (Responsible Party):
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Osteoporosis
Multiple Sclerosis
Interventions Drug: Zoledronic Acid
Drug: Placebo
Dietary Supplement: Calcium and Vitamin D combination
Enrollment 29
Recruitment Details 168 participants were planned to be randomized. 29 participants were randomized in a 2:1 ratio (zoledronic acid : placebo); no participants completed the study. One participant withdrew consent and the study was terminated.
Pre-assignment Details  
Arm/Group Title Zoledronic Acid Placebo
Hide Arm/Group Description Participants received zoledronic acid infusion in addition to calcium and vitamin D Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
Period Title: Overall Study
Started 21 8
Completed 0 0
Not Completed 21 8
Reason Not Completed
Withdrawal by Subject             1             0
Study was terminated             20             8
Arm/Group Title Zoledronic Acid Placebo Total
Hide Arm/Group Description Participants received zoledronic acid infusion in addition to calcium and vitamin D Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D Total of all reporting groups
Overall Number of Baseline Participants 21 8 29
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 8 participants 29 participants
60.1  (8.0) 56.0  (8.2) 59.0  (8.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 8 participants 29 participants
Female
16
  76.2%
7
  87.5%
23
  79.3%
Male
5
  23.8%
1
  12.5%
6
  20.7%
1.Primary Outcome
Title Change in Bone Mineral Density of the Lumbar Spine at 12 Months
Hide Description

Change in bone mineral density (BMD) of the lumbar spine was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 12.

A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone.

Time Frame Screening (day -21 to -1) and month 12
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.
Arm/Group Title Zoledronic Acid Placebo
Hide Arm/Group Description:
Participants received zoledronic acid infusion in addition to calcium and vitamin D
Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Change in Bone Mineral Density of the Total Hip Region at 12 Months
Hide Description

Change in bone mineral density (BMD) of the total hip region was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 12.

A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone.

Time Frame Screening (day -21 to -1) and month 12
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.
Arm/Group Title Zoledronic Acid Placebo
Hide Arm/Group Description:
Participants received zoledronic acid infusion in addition to calcium and vitamin D
Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Change in Bone Mineral Density of the Lumbar Spine at 6 Months
Hide Description

Change in bone mineral density (BMD) of the lumbar spine was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 6.

A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone.

Time Frame Screening (day -21 to -1) and month 6
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.
Arm/Group Title Zoledronic Acid Placebo
Hide Arm/Group Description:
Participants received zoledronic acid infusion in addition to calcium and vitamin D
Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Change in Bone Mineral Density of the Femoral Neck at 6 Months
Hide Description

Change in bone mineral density (BMD) of the femoral neck was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 6.

A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone.

Time Frame Screening (day -21 to -1) and month 6
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.
Arm/Group Title Zoledronic Acid Placebo
Hide Arm/Group Description:
Participants received zoledronic acid infusion in addition to calcium and vitamin D
Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Change in Bone Mineral Density of the Total Hip at 6 Months
Hide Description Change in bone mineral density (BMD) of the total hip was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 6. A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone.
Time Frame Screening (day -21 to -1) and month 6
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.
Arm/Group Title Zoledronic Acid Placebo
Hide Arm/Group Description:
Participants received zoledronic acid infusion in addition to calcium and vitamin D
Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Change in Bone Mineral Density of the Femoral Neck at 12 Months
Hide Description

Change in bone mineral density (BMD) of the femoral neck was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 12.

A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone.

Time Frame Screening (day -21 to -1) and month 12
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.
Arm/Group Title Zoledronic Acid Placebo
Hide Arm/Group Description:
Participants received zoledronic acid infusion in addition to calcium and vitamin D
Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Change in Bone Mineral Density of the Lumbar Spine at 24 Months
Hide Description

Change in bone mineral density (BMD) of the lumbar spine was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 24.

A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone.

Time Frame Screening (day -21 to -1) and month 24
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.
Arm/Group Title Zoledronic Acid Placebo
Hide Arm/Group Description:
Participants received zoledronic acid infusion in addition to calcium and vitamin D
Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Change in Bone Mineral Density of the Total Hip Region at 24 Months
Hide Description

Change in bone mineral density (BMD) of the total hip region was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 24.

A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone.

Time Frame Screening (day -21 to -1) and month 24
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.
Arm/Group Title Zoledronic Acid Placebo
Hide Arm/Group Description:
Participants received zoledronic acid infusion in addition to calcium and vitamin D
Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Change in Bone Mineral Density of the Femoral Neck at 24 Months
Hide Description

Change in bone mineral density (BMD) of the femoral neck was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 24.

A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone.

Time Frame Screening (day -21 to -1) and month 24
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.
Arm/Group Title Zoledronic Acid Placebo
Hide Arm/Group Description:
Participants received zoledronic acid infusion in addition to calcium and vitamin D
Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Course of Disease in Multiple Sclerosis Patients
Hide Description The course of disease in Multiple Sclerosis (MS) patients was measured comparing results from the Expanded Disability Status Scale (EDSS) from screening and month 12. EDSS is a scale, ranging from 0 (normal) to 10 (death due to MS) for assessing neurologic impairment in MS. It is based on a weighting scheme of eight functional systems. The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel&Bladder, Cerebral and Other functions. EDSS was assessed by the treating neurologist.
Time Frame Screening (day -21 to -1) and month 12
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.
Arm/Group Title Zoledronic Acid Placebo
Hide Arm/Group Description:
Participants received zoledronic acid infusion in addition to calcium and vitamin D
Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Adverse Events and Serious Adverse Events Comparison of Treatment Groups
Hide Description Adverse Events and Serious Adverse events are reported in the safety section.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done. The sample size was not powered for comparison between groups; however, all AEs are reported in the safety section.
Arm/Group Title Zoledronic Acid Placebo
Hide Arm/Group Description:
Participants received zoledronic acid infusion in addition to calcium and vitamin D
Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Zoledronic Acid Placebo
Hide Arm/Group Description Participants received zoledronic acid infusion in addition to calcium and vitamin D Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
All-Cause Mortality
Zoledronic Acid Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Zoledronic Acid Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/21 (9.52%)      0/8 (0.00%)    
Nervous system disorders     
LOSS OF CONSCIOUSNESS  1  1/21 (4.76%)  0/8 (0.00%) 
MULTIPLE SCLEROSIS  1  1/21 (4.76%)  0/8 (0.00%) 
Psychiatric disorders     
DEPRESSION  1  1/21 (4.76%)  0/8 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Zoledronic Acid Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/21 (76.19%)      5/8 (62.50%)    
Gastrointestinal disorders     
NAUSEA  1  0/21 (0.00%)  0 1/8 (12.50%) 
General disorders     
FATIGUE  1  2/21 (9.52%)  0/8 (0.00%) 
GAIT DISTURBANCE  1  1/21 (4.76%)  1/8 (12.50%) 
INFLUENZA LIKE ILLNESS  1  7/21 (33.33%)  1/8 (12.50%) 
PYREXIA  1  1/21 (4.76%)  1/8 (12.50%) 
Injury, poisoning and procedural complications     
ARTHROPOD BITE  1  0/21 (0.00%)  1/8 (12.50%) 
Investigations     
WHITE BLOOD CELLS URINE POSITIVE  1  2/21 (9.52%)  1/8 (12.50%) 
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  2/21 (9.52%)  1/8 (12.50%) 
ARTHRITIS  1  0/21 (0.00%)  1/8 (12.50%) 
BACK PAIN  1  2/21 (9.52%)  0/8 (0.00%) 
BONE PAIN  1  2/21 (9.52%)  0/8 (0.00%) 
MUSCULAR WEAKNESS  1  0/21 (0.00%)  1/8 (12.50%) 
MUSCULOSKELETAL PAIN  1  0/21 (0.00%)  2/8 (25.00%) 
PAIN IN EXTREMITY  1  3/21 (14.29%)  2/8 (25.00%) 
Nervous system disorders     
DIZZINESS  1  1/21 (4.76%)  2/8 (25.00%) 
HEADACHE  1  7/21 (33.33%)  2/8 (25.00%) 
MULTIPLE SCLEROSIS RELAPSE  1  2/21 (9.52%)  1/8 (12.50%) 
Respiratory, thoracic and mediastinal disorders     
ASTHMA  1  0/21 (0.00%)  1/8 (12.50%) 
Vascular disorders     
HYPERTENSION  1  2/21 (9.52%)  0/8 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 15.1
Study termination due to small number of participants recruited lead to lack of power for analysis of all outcome measures.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis
Phone: 41 61 324 1111
Layout table for additonal information
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01166178     History of Changes
Other Study ID Numbers: CZOL446HDE40
2009-011888-37 ( EudraCT Number )
First Submitted: July 19, 2010
First Posted: July 20, 2010
Results First Submitted: June 3, 2013
Results First Posted: November 26, 2013
Last Update Posted: November 26, 2013