A Study to Assess the Efficacy of Intravenous/Oral Bondro... | NCT00099177

Studies
A Study to Assess the Efficacy of Intravenous/Oral Bondronat (Ibandronate) in Patients With Metastatic Bone Disease Experiencing Moderate to Severe Pain

NCT00099177

Sponsor

Hoffmann-La Roche

Status

Terminated

Last Update Posted

Aug 16, 2017Actual

Enrollment

96Actual

Phase

Phase 3

Conditions

Pain
Bone Neoplasm
Neoplasm Metastasis

Interventions

ibandronate [Bondronat]
zoledronic acid

Countries

United States
Argentina
Australia
Chile
Germany
Greece
Guatemala
Hungary
Italy
Mexico
Panama
Poland
Puerto Rico
Russia
Switzerland
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2005

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Dec 10, 2004

First Submission Date that Met QC Criteria

Dec 9, 2004

First Posted Date

Dec 10, 2004Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 14, 2017

Last Update Posted Date

Aug 16, 2017Actual

Description Module

Brief Summary

This 2 arm study will compare the efficacy of a regimen of intravenous (iv) and oral 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 followed by Bondronat 5Omg po daily from day 22 to week 24) 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

96Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: ibandronate [Bondronat]
2	Active Comparator		Drug: zoledronic acid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ibandronate [Bondronat]	Drug	6mg iv on days 1-3, and 50mg po from day 22 to week 24	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain, as measured by Brief Pain Inventory and analgesic use		Week 24

Secondary Outcomes

Measure	Description	Time Frame
Performance score and QoL measures		Week 24
AEs and laboratory parameters		Throughout study
Opioid side effects

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Miami	Florida	33136	United States

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D009371	Neoplasms by Site
D009369	Neoplasms
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D009385	Neoplastic Processes
D010335	Pathologic Processes

ID	Term
D000077557	Ibandronic Acid
D000077211	Zoledronic Acid

ID	Term
D004164	Diphosphonates
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds