Comparison of Pamidronate With Zoledronic Acid for Transp... | NCT00164008

Studies
Comparison of Pamidronate With Zoledronic Acid for Transplant Related Bone Loss Prevention

NCT00164008

Sponsor

Bayside Health

Status

Completed

Last Update Posted

Dec 5, 2013Estimated

Enrollment

56Actual

Phase

Phase 4

Conditions

Osteopenia
Complications of Heart-lung Transplant
Other Complications of Lung Transplant

Interventions

zoledronic acid vs pamidronate

Countries

Not provided

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2002

Primary Completion Date

Dec 2005Actual

Completion Date

Dec 2005Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 14, 2005Estimated

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

Dec 3, 2013

Last Update Posted Date

Dec 5, 2013Estimated

Name	Class
Novartis	INDUSTRY

Description Module

Brief Summary

The purpose of this trial is to see whether zoledronic acid is better than pamidronate to treat low bone density in heart and lung transplant patients.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Actual

Name	Type	Description	Arm Group Labels	Other Names
zoledronic acid vs pamidronate	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bone mineral density of lumbar spine at 12 months as measured by DEXA.

Secondary Outcomes

Measure	Description	Time Frame
Bone mineral density of femoral neck at 12 months as measured by DEXA.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

reduced bone density as indicated by a bone density T score <-1.in either the lumbar spine or femoral neck
have undergone or are on the waiting list for heart or lung transplantation
are receiving adequate calcium and vitamin D therapy
have provided written informed consent prior to participation in the trial

Exclusion Criteria:

untreated hypogonadism, hypothyroidism or hyperthyroidism
acute or major organ rejection or intercurrent illness
pregnancy or breastfeeding

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

Name	Affiliation	Role
Duncan J Topliss, MD	The Alfred	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D001851	Bone Diseases, Metabolic

Ancestor Terms

ID	Term
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided