A Study to Assess the Efficacy of Intravenous Bondronat (Ibandronate) in Patients With Malignant and Painful Bone Disease

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Terminated

CT.gov ID

NCT00099203

Collaborator

(none)

163

Enrollment

Locations

Arms

Duration (Months)

2.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This 2 arm study will compare the efficacy of intravenous Bondronat with that of zoledronic acid in patients with malignant bone disease experiencing moderate to severe pain. Patients will be randomized to receive either Bondronat (6mg iv on days 1, 2 and 3 and then every 3-4 weeks) or zoledronic acid (4mg iv on day 1 and then every 3-4 weeks). The anticipated time of study treatment is 6-12 months, and the target sample size is 100-500 individuals.

Condition or Disease	Intervention/Treatment	Phase
Pain Bone Neoplasm Neoplasm Metastasis	Drug: ibandronate [Bondronat] Drug: zoledronic acid	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

163 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Randomized, Placebo-controlled, Double-blind Study of the Effect of Bondronat Compared With Zoledronic Acid on Pain in Patients With Malignant Bone Disease Experiencing Moderate to Severe Pain

Study Start Date :

Jul 1, 2005

Actual Primary Completion Date :

Dec 1, 2007

Actual Study Completion Date :

Dec 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: ibandronate [Bondronat] 6mg iv on days 1-3, and every 3-4 weeks
Active Comparator: 2	Drug: zoledronic acid 4mg iv on day 1 and every 3-4 weeks

Arm

Intervention/Treatment

Experimental: 1

Drug: ibandronate [Bondronat]

6mg iv on days 1-3, and every 3-4 weeks

Active Comparator: 2

Drug: zoledronic acid

4mg iv on day 1 and every 3-4 weeks

Outcome Measures

Primary Outcome Measures

Pain, as measured by Brief Pain Inventory and analgesic use [Week 24]

Secondary Outcome Measures

Performance score and QoL measures [Week 24]
AEs and laboratory parameters [Throughout study]
Opioid side effects [Throughout study]
Skeletal-related events [Throughout study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patients with malignant bone disease;
patients with moderate to severe pain.

Exclusion Criteria:

patients who have received a bisphosphonate within 3 weeks from the signing of the informed consent;
patients receiving concurrent investigational therapy, or who have received investigational therapy within 30 days of the first scheduled day of dosing;
untreated esophagitis or gastric ulcers;
recent or pre-scheduled radiotherapy to bone;
patients who are pregnant or breast-feeding.

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Birmingham	Alabama	United States	35205
2	Sedona	Arizona	United States	86336
3	Ocoee	Florida	United States	34761
4	Macon	Georgia	United States	31201
5	Galesburg	Illinois	United States	61401
6	Indianapolis	Indiana	United States	46227
7	Kansas City	Missouri	United States	64131
8	Henderson	Nevada	United States	89052
9	Reno	Nevada	United States	89502
10	Albany	New York	United States	12208
11	Oklahoma City	Oklahoma	United States	73120
12	Eugene	Oregon	United States	97401-8122
13	Nashville	Tennessee	United States	37209
14	Abilene	Texas	United States	79606-5208
15	Arlington	Texas	United States	76014
16	Beaumont	Texas	United States	77702-1449
17	Dallas	Texas	United States	75230
18	Dallas	Texas	United States	75231
19	Fort Worth	Texas	United States	76177
20	Fredericksburg	Texas	United States	78624
21	Longview	Texas	United States	75601
22	Round Rock	Texas	United States	78681
23	Norfolk	Virginia	United States	23502
24	Seattle	Washington	United States	98104
25	Spokane	Washington	United States	99218
26	Vancouver	Washington	United States	98684
27	Buenos Aires		Argentina	C1280AEB
28	Buenos Aires		Argentina	C1406FWY
29	Buenos Aires		Argentina	C1408INH
30	La Plata		Argentina	1900
31	Lanus		Argentina	B1824DLR
32	Mendoza		Argentina	5500
33	St. Leonards		Australia	2065
34	Waratah		Australia	2298
35	Bruxelles		Belgium	1000
36	Turnhout		Belgium	2300
37	Wilrijk		Belgium	2610
38	Greenfield Park	Quebec	Canada	J4V 2H1
39	Santiago		Chile
40	Lyon		France	69373
41	Nice		France	06189
42	Paris		France	75248
43	Dessau		Germany	06846
44	Duisburg		Germany	47166
45	Heidelberg		Germany	69120
46	Trier		Germany	54290
47	Guatemala City		Guatemala	01010
48	Guatemala City		Guatemala	01015
49	Guatemala City		Guatemala
50	Budapest		Hungary	1125
51	Gyor		Hungary	9002
52	Napoli		Italy	80131
53	Chihuahua		Mexico	31000
54	Merida		Mexico	97500
55	Mexico City		Mexico	03100
56	Panama City		Panama
57	Lodz		Poland	93-510
58	Olsztyn		Poland	10-228
59	Otwock		Poland	05-400
60	Ponce		Puerto Rico	00733-1324
61	San Juan		Puerto Rico	00921-3201
62	Kazan		Russian Federation	420029
63	Moscow		Russian Federation	115478
64	Moscow		Russian Federation	117837
65	Moscow		Russian Federation	125284
66	Moscow		Russian Federation
67	Obninsk		Russian Federation	249020
68	St Petersburg		Russian Federation	197022
69	St Petersburg		Russian Federation	197758
70	Baden		Switzerland	5404
71	Exeter		United Kingdom	EX2 5DW
72	Wolverhampton		United Kingdom	WV10 0QP