NCT00302627

Brief Summary

Bone is lost rapidly and fractures occur in 10-20% of patients who receive organ transplants within 2 years. The purpose of this study is to evaluate long-term effects of a pamidronate-vitamin D-calcium regimen on bone loss, fractures, and safety in recipients of kidney and heart transplants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 1999

Longer than P75 for not_applicable

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

January 1, 1999

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2002

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 14, 2006

Completed
Last Updated

August 29, 2018

Status Verified

August 1, 2018

Enrollment Period

3.8 years

First QC Date

March 10, 2006

Last Update Submit

August 27, 2018

Conditions

Transplant Bone Disease

Keywords

bisphosphonatesvitamin Dcalcium supplementcorticosteroid therapyfractures

Outcome Measures

Primary Outcomes (1)

  • Bone mineral density measured by dual-energy X-ray absorptiometry

    Performed at 1 year and 2 years.

    Every 12 months

Secondary Outcomes (5)

  • Fracture events

    Every 6 months

  • serum calcium

    Every 6 months

  • parathyroid hormone

    Every 6 months

  • serum creatinine and estimated glomerular filtration rate

    Every 6 months

  • proteinuria

    Every 6 months

Study Arms (1)

Pamidronate, Vitamin D, and Calcium

EXPERIMENTAL

60mg or 90mg given at baseline, 6,12,18, and 24 months vitamin D 800 units/day calcium carbonate 1500 milligrams/day

Drug: PamidronateDrug: vitamin DDrug: Calcium Carbonate

Interventions

PamidronateDRUG

60mg or 90mg given at baseline, 6,12,18, and 24 months

Also known as: Transplant Bone Disease
Pamidronate, Vitamin D, and Calcium
vitamin DDRUG

baseline, 6,12 months

Also known as: Vitamin D administration in Transplant
Pamidronate, Vitamin D, and Calcium
Calcium CarbonateDRUG

baseline, 6,12 months

Also known as: Calcium administration in Transplant
Pamidronate, Vitamin D, and Calcium

Eligibility Criteria

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

You may qualify if:

  • Kidney or heart transplant recipients

You may not qualify if:

  • Hyperparathyroidism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Providence Medical Research Center

Spokane, Washington, 99204, United States

Location

MeSH Terms

Conditions

Fractures, Bone

Interventions

PamidronateVitamin DTransplantationCalcium Carbonate

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsSecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsSurgical Procedures, OperativeCalcium CompoundsInorganic ChemicalsCarbonatesCarbonic AcidCarbon Compounds, InorganicMinerals

Study Officials

  • Katherine R. Tuttle, MD,FASN,FACP

    Providence Medical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2006

First Posted

March 14, 2006

Study Start

January 1, 1999

Primary Completion

November 1, 2002

Study Completion

November 1, 2002

Last Updated

August 29, 2018

Record last verified: 2018-08

Locations

US(1)