NCT00738257

Brief Summary

The purpose of the study was to evaluate the effect of Pamidronate on bone mineral density loss and fracture rates up to 2 years, in post renal-transplant subjects on a Ciclosporin A and glucocorticoid based immunosuppressive regimen.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2000

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2008

Completed
Last Updated

May 17, 2010

Status Verified

May 1, 2010

Enrollment Period

4.5 years

First QC Date

August 18, 2008

Last Update Submit

May 14, 2010

Conditions

Bone Loss

Keywords

Renaltransplant,pamidronate,ciclosporin,Ciclosporin A,steroids,bone mineral density,fracture ratesimmunosuppressiveregimen

Study Arms (1)

Parmidronate

EXPERIMENTAL
Drug: Pamidronate

Interventions

PamidronateDRUG
Parmidronate

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First or second kidney transplant recipients, aged 18-75 years, PTH \> 150 pg/ml
  • De novo patients scheduled to receive ciclosporin A and prednisolone based immunosuppression.

You may not qualify if:

  • Previous or current bone disease unrelated to end stage renal failure.
  • Patients with PTH \< 150pg/ml who may be at risk of adynamic bone disease.
  • Treatment at any time with a bisphosphonate.
  • d. Calcitonin treatment during the previous month.
  • Malignancy (current or history within last 5 years)
  • Pregnancy or lactation, or women of childbearing potential unwilling to use an effective form of contraception for the 12 month duration of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Frimley, United Kingdom

Location

Related Publications (1)

  • Walsh SB, Altmann P, Pattison J, Wilkie M, Yaqoob MM, Dudley C, Cockwell P, Sweny P, Banks LM, Hall-Craggs M, Noonan K, Andrews C, Cunningham J. Effect of pamidronate on bone loss after kidney transplantation: a randomized trial. Am J Kidney Dis. 2009 May;53(5):856-65. doi: 10.1053/j.ajkd.2008.11.036.

    PMID: 19393473DERIVED

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Pamidronate

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Study Officials

  • John Cunningham, MD

    Royal London Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 18, 2008

First Posted

August 20, 2008

Study Start

June 1, 2000

Primary Completion

December 1, 2004

Last Updated

May 17, 2010

Record last verified: 2010-05

Locations

GB(1)