Safety and Efficacy Trial With Zoledronic Acid for the Tr... | NCT00051636

NCT00051636

ID	Type	Description	Link
ZOL446K2304	Other Identifier	Novartis Pharmaceuticals

Status Module

Sponsor/Collaborators Module

Oversight Module

No data available

No data is available for this block.

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Zoledronic Acid and Placebo to Risedronate	Experimental	Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.	Drug: Zoledronic Acid Drug: Placebo to Risedronate Dietary Supplement: Calcium and Vitamin D
Risedronate and Placebo to Zoledronic Acid	Active Comparator	Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.	Drug: Risedronate Drug: Placebo to Zoledronic Acid Dietary Supplement: Calcium and Vitamin D

Name	Type	Description	Arm Group Labels	Other Names
Zoledronic Acid	Drug	Zoledronic acid 5 mg in 5 mL of sterile water intravenous infusion.	Zoledronic Acid and Placebo to Risedronate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Patients Who Achieve Therapeutic Response at 6 Months.	Therapeutic response is defined as a reduction of at least 75% from baseline (Visit 1) in total serum alkaline phosphatase excess (difference between measured level and midpoint to the normal range) or normalization of serum alkaline phosphatase at the end of six months.	6 months

Secondary Outcomes

Measure	Description	Time Frame
Relative Change in Serum Alkaline Phosphatase (SAP) in Units Per Liter (U/L) at Day 28	The percent change in serum alkaline phosphatase from baseline to day 28 was measured.	Baseline and day 28
Relative Change in Serum C-telopeptide (CTx) in ng/mL at Day 10

Eligibility Module

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Santa Monica	California	90414	United States
Novartis Investigative Site

References Module

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No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Zoledronic Acid and Placebo to Risedronate	Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Zoledronic Acid and Placebo to Risedronate	Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
BG001	Risedronate and Placebo to Zoledronic Acid	Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG00085 OG00160

Secondary

Relative Change in Serum Alkaline Phosphatase (SAP) in Units Per Liter (U/L) at Day 28

The percent change in serum alkaline phosphatase from baseline to day 28 was measured.

Intent-to-treat population: all randomized patients. Participants with observations at baseline and 28 days were included in this analysis.

Posted

Mean

Standard Deviation

percent change

Baseline and day 28

ID	Title	Description
OG000	Zoledronic Acid and Placebo to Risedronate	Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
OG001	Risedronate and Placebo to Zoledronic Acid	Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.

Units	Counts

Secondary

Relative Change in Serum C-telopeptide (CTx) in ng/mL at Day 10

The percent change in serum C-telopeptide from baseline to day 10 was measured.

Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 10 were included in this analysis.

Posted

Mean

Standard Deviation

percent change

Baseline and day 10

ID	Title	Description
OG000	Zoledronic Acid and Placebo to Risedronate	Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
OG001	Risedronate and Placebo to Zoledronic Acid	Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.

Units	Counts
Participants

Secondary

Relative Change in Urine Alpha C-telopeptide (α-CTx) in ug/mmol at Day 10

The percent change in urine alpha C-telopeptide from baseline to day 10 was measured.

Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 10 were included in this analysis.

Posted

Mean

Standard Deviation

Percent change

Baseline and day 10

ID	Title	Description
OG000	Zoledronic Acid and Placebo to Risedronate	Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
OG001	Risedronate and Placebo to Zoledronic Acid	Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.

Units	Counts

Secondary

Time to First Therapeutic Response

A therapeutic response was defined as a reduction of at least 75% from baseline (Visit 1) in serum alkaline phosphatase excess (difference between measured level and midpoint to the normal range) or normalization of serum alkaline phosphatase.

Intent-to-treat population: all randomized patients.

Posted

Median

Inter-Quartile Range

Days

182 days

ID	Title	Description
OG000	Zoledronic Acid and Placebo to Risedronate	Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
OG001	Risedronate and Placebo to Zoledronic Acid	Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.

Units	Counts

Secondary

Number of Patients Who Achieved Serum Alkaline Phosphatase Normalization at Day 28 Relative to Baseline

Normalization of serum alkaline phosphatase occurred if the serum alkaline phosphatase measurement fell within the normal range.

Intent-to-treat population: all randomized patients. Participants with observations at day 28 were included in this analysis.

Posted

Number

Participants

Baseline and day 28

ID	Title	Description
OG000	Zoledronic Acid and Placebo to Risedronate	Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
OG001	Risedronate and Placebo to Zoledronic Acid	Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.

Units	Counts

Secondary

Change in Pain Severity Score

Change in pain severity score from Brief Pain Inventory-Short Form (BPI-SF). This scale values are 0 to 10, a lower score means little to no pain while a higher score means greater pain.

Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 182 were included in this analysis.

Posted

Mean

Standard Deviation

Units on a scale

Baseline and day 182

ID	Title	Description
OG000	Zoledronic Acid and Placebo to Risedronate	Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
OG001	Risedronate and Placebo to Zoledronic Acid	Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.

Units	Counts

Secondary

Change in Pain Interference Score

Change in pain interference score from Brief Pain Inventory-Short Form (BPI-SF). This scale values are 0 to 10, a lower score means little to no pain while a higher score means greater pain.

Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 182 were included in this analysis.

Posted

Mean

Standard Deviation

Units on a scale

Baseline and day 182

ID	Title	Description
OG000	Zoledronic Acid and Placebo to Risedronate	Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
OG001	Risedronate and Placebo to Zoledronic Acid	Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.

Units	Counts

Secondary

Number of Participants With a Loss of Therapeutic Response During the Extended Observation Period

Extended observation period. A therapeutic response is defined as a reduction of at least 75% from baseline in serum alkaline phosphatase excess or normalization of serum alkaline phosphatase.

Extended modified Intent-to-treat population: patients who had at least one serum alkaline phosphatase measurement during the extension period.

Posted

Number

Participants

8 years was the maximum

ID	Title	Description
OG000	Zoledronic Acid and Placebo to Risedronate	Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
OG001	Risedronate and Placebo to Zoledronic Acid	Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.

Secondary

Number of Participants With a Partial Disease Relapse During the Extended Observation Period

Extended observation period. A partial disease relapse was defined as an increase in serum alkaline phosphatase >= 50% from the serum alkaline phosphatase measurement at month 6 and at least 1.25 times the upper normal limit.

Extended modified Intent-to-treat population: patients who had at least one serum alkaline phosphatase measurement during the extension period.

Posted

Number

Participants

8 years was the maximum

ID	Title	Description
OG000	Zoledronic Acid and Placebo to Risedronate	Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
OG001	Risedronate and Placebo to Zoledronic Acid	Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.

Secondary

Number of Participants With a Disease Relapse During the Extended Observation Period

Extended observation period. A disease relapse was defined as the occurrence of a serum alkaline phosphatase level that was >= 80% of baseline serum alkaline phosphatase value.

Extended modified Intent-to-treat population: patients who had at least one serum alkaline phosphatase measurement during the extension period.

Posted

Number

Participants

8 years was the maximum

ID	Title	Description
OG000	Zoledronic Acid and Placebo to Risedronate	Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
OG001	Risedronate and Placebo to Zoledronic Acid	Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Zoledronic Acid and Placebo to Risedronate	Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.			5	89	71	89
EG001	Risedronate and Placebo to Zoledronic Acid	Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.			8	82	58	82

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute coronary syndrome	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected89 at risk EG0011 affected82 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected89 at risk EG0011 affected82 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected89 at risk EG0011 affected82 at risk
Constipation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected89 at risk EG0011 affected82 at risk
Dysphagia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected89 at risk EG0011 affected82 at risk
Asthenia	General disorders	MedDRA	Systematic Assessment	EG0001 affected89 at risk EG0010 affected82 at risk
Difficulty in walking	General disorders	MedDRA	Systematic Assessment	EG0001 affected89 at risk EG0010 affected82 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG0000 affected89 at risk EG0011 affected82 at risk
Rigors	General disorders	MedDRA	Systematic Assessment	EG0000 affected89 at risk EG0011 affected82 at risk
Hepatic cyst	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected89 at risk EG0011 affected82 at risk
Cellulitis orbital	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected89 at risk EG0010 affected82 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected89 at risk EG0011 affected82 at risk
Staphylococcal infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected89 at risk EG0011 affected82 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected89 at risk EG0011 affected82 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected89 at risk EG0011 affected82 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected89 at risk EG0011 affected82 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected89 at risk EG0010 affected82 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected89 at risk EG0011 affected82 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected89 at risk EG0010 affected82 at risk
Embolic stroke	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected89 at risk EG0010 affected82 at risk
Confusional state	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected89 at risk EG0011 affected82 at risk
Renal impairment	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected89 at risk EG0011 affected82 at risk
Leg amputation	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 affected89 at risk EG0010 affected82 at risk
Sympathectomy	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 affected89 at risk EG0010 affected82 at risk
Peripheral ischaemia	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected89 at risk EG0010 affected82 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0005 affected89 at risk EG0016 affected82 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0005 affected89 at risk EG0013 affected82 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0007 affected89 at risk EG0013 affected82 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00010 affected89 at risk EG0018 affected82 at risk
Fatigue	General disorders	MedDRA	Systematic Assessment	EG0008 affected89 at risk EG0015 affected82 at risk
Influenza like illness	General disorders	MedDRA	Systematic Assessment	EG0006 affected89 at risk EG0014 affected82 at risk
Oedema peripheral	General disorders	MedDRA	Systematic Assessment	EG0005 affected89 at risk EG0011 affected82 at risk
Pain	General disorders	MedDRA	Systematic Assessment	EG0007 affected89 at risk EG0015 affected82 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG00011 affected89 at risk EG0011 affected82 at risk
Rigors	General disorders	MedDRA	Systematic Assessment	EG00013 affected89 at risk EG0010 affected82 at risk
Influenza	Infections and infestations	MedDRA	Systematic Assessment	EG0008 affected89 at risk EG0016 affected82 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG0008 affected89 at risk EG00110 affected82 at risk
Fall	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0008 affected89 at risk EG0014 affected82 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0005 affected89 at risk EG0010 affected82 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00011 affected89 at risk EG00115 affected82 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0005 affected89 at risk EG0018 affected82 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0009 affected89 at risk EG0016 affected82 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00010 affected89 at risk EG0014 affected82 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0009 affected89 at risk EG0019 affected82 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG00010 affected89 at risk EG0013 affected82 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG00010 affected89 at risk EG00111 affected82 at risk
Lethargy	Nervous system disorders	MedDRA	Systematic Assessment	EG0009 affected89 at risk EG0011 affected82 at risk

ID	Term
D010001	Osteitis Deformans

ID	Term
D000077211	Zoledronic Acid
D000068296	Risedronic Acid
D002118	Calcium
D014807	Vitamin D

Ancestor Terms

ID	Term
D004164	Diphosphonates
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D011725	Pyridines
D008673	Metals, Alkaline Earth
D004602	Elements
D007287	Inorganic Chemicals
D008670	Metals
D001779	Blood Coagulation Factors
D001685	Biological Factors
D012632	Secosteroids
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

ID	Term
D001847	Bone Diseases
D009140	Musculoskeletal Diseases