Trial Outcomes & Findings for Zoledronic Acid in MS-patients With Osteoporosis (NCT NCT01166178)

NCT ID: NCT01166178

Last Updated: 2013-11-26

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 29 participants
• Primary outcome timeframe: Screening (day -21 to -1) and month 12
• Results posted on: 2013-11-26

Participant Flow

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.

Participant milestones

Measure	Zoledronic Acid Participants received zoledronic acid infusion in addition to calcium and vitamin D	Placebo Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
Overall Study STARTED	21	8
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	21	8

Reasons for withdrawal

Measure	Zoledronic Acid Participants received zoledronic acid infusion in addition to calcium and vitamin D	Placebo Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
Overall Study Withdrawal by Subject	1	0
Overall Study Study was terminated	20	8

Baseline Characteristics

Zoledronic Acid in MS-patients With Osteoporosis

Baseline characteristics by cohort

Measure	Zoledronic Acid n=21 Participants Participants received zoledronic acid infusion in addition to calcium and vitamin D	Placebo n=8 Participants Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D	Total n=29 Participants Total of all reporting groups
Age Continuous	60.1 years STANDARD_DEVIATION 8.0 • n=5 Participants	56.0 years STANDARD_DEVIATION 8.2 • n=7 Participants	59.0 years STANDARD_DEVIATION 8.1 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	7 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: Screening (day -21 to -1) and month 12

Population: 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.

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Screening (day -21 to -1) and month 12

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Screening (day -21 to -1) and month 6

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Screening (day -21 to -1) and month 6

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Screening (day -21 to -1) and month 6

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Screening (day -21 to -1) and month 12

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Screening (day -21 to -1) and month 24

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Screening (day -21 to -1) and month 24

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Screening (day -21 to -1) and month 24

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Screening (day -21 to -1) and month 12

Population: 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 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Population: 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.

Adverse Events and Serious Adverse events are reported in the safety section.

Outcome measures

Outcome data not reported

Adverse Events

Zoledronic Acid

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Zoledronic Acid n=21 participants at risk Participants received zoledronic acid infusion in addition to calcium and vitamin D	Placebo n=8 participants at risk Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
Nervous system disorders LOSS OF CONSCIOUSNESS	4.8% 1/21	0.00% 0/8
Nervous system disorders MULTIPLE SCLEROSIS	4.8% 1/21	0.00% 0/8
Psychiatric disorders DEPRESSION	4.8% 1/21	0.00% 0/8

Other adverse events

Measure	Zoledronic Acid n=21 participants at risk Participants received zoledronic acid infusion in addition to calcium and vitamin D	Placebo n=8 participants at risk Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
Gastrointestinal disorders NAUSEA	0.00% 0/21	12.5% 1/8
General disorders FATIGUE	9.5% 2/21	0.00% 0/8
General disorders GAIT DISTURBANCE	4.8% 1/21	12.5% 1/8
General disorders INFLUENZA LIKE ILLNESS	33.3% 7/21	12.5% 1/8
General disorders PYREXIA	4.8% 1/21	12.5% 1/8
Injury, poisoning and procedural complications ARTHROPOD BITE	0.00% 0/21	12.5% 1/8
Investigations WHITE BLOOD CELLS URINE POSITIVE	9.5% 2/21	12.5% 1/8
Musculoskeletal and connective tissue disorders ARTHRALGIA	9.5% 2/21	12.5% 1/8
Musculoskeletal and connective tissue disorders ARTHRITIS	0.00% 0/21	12.5% 1/8
Musculoskeletal and connective tissue disorders BACK PAIN	9.5% 2/21	0.00% 0/8
Musculoskeletal and connective tissue disorders BONE PAIN	9.5% 2/21	0.00% 0/8
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	0.00% 0/21	12.5% 1/8
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	0.00% 0/21	25.0% 2/8
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	14.3% 3/21	25.0% 2/8
Nervous system disorders DIZZINESS	4.8% 1/21	25.0% 2/8
Nervous system disorders HEADACHE	33.3% 7/21	25.0% 2/8
Nervous system disorders MULTIPLE SCLEROSIS RELAPSE	9.5% 2/21	12.5% 1/8
Respiratory, thoracic and mediastinal disorders ASTHMA	0.00% 0/21	12.5% 1/8
Vascular disorders HYPERTENSION	9.5% 2/21	0.00% 0/8

Additional Information

Study Director

Novartis

Phone: 41 61 324 1111

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 (i.e., data from all sites) in the clinical trial.
• Publication restrictions are in place

Restriction type: OTHER