NCT00000412

Brief Summary

During the first year after a heart transplant, people often rapidly lose bone from their spine and hips. About 35 percent of people who receive heart transplants will suffer broken bones during the first year after transplantation. This study will compare the safety and effectiveness of the drug alendronate (Fosamax) and the active form of vitamin D (calcitriol) in preventing bone loss at the spine and hip after a heart transplant. In this study, people who have had a successful heart transplant will receive either active alendronate and a "dummy pill" instead of calcitriol, or active calcitriol and a dummy pill instead of alendronate for the first year after their transplant, starting within 1 month after transplant surgery. We will measure bone density in the hip and spine at the start of the study and after 6 and 12 months, and will also check for broken bones in the spine. This research should lead to ways of preventing this crippling form of osteoporosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
149

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 1997

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

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

September 1, 1997

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2002

Completed
Last Updated

July 7, 2015

Status Verified

July 1, 2015

Enrollment Period

4.6 years

First QC Date

November 3, 1999

Last Update Submit

July 2, 2015

Conditions

OsteoporosisCardiac Transplantation

Keywords

OsteoporosisOsteopeniaHeart transplantBone fractureBone densityDual energy x-ray absorptiometry

Study Arms (2)

Group A

ACTIVE COMPARATOR

Group A active alendronate (10 mg/day) and placebo calcitriol.

Drug: AlendronateDrug: Placebo Calcitriol

Group B

PLACEBO COMPARATOR

We will give Group B placebo alendronate and active calcitriol (0.25 micrograms BID).

Drug: CalcitriolDrug: Placebo Alendronate

Interventions

AlendronateDRUG
Group A
CalcitriolDRUG
Group B
Placebo AlendronateDRUG
Group B
Placebo CalcitriolDRUG
Group A

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cardiac transplantation

You may not qualify if:

  • Active peptic ulcer disease, gastrectomy, inflammatory bowel disease, malignancy, Paget's disease of bone, osteogenesis imperfecta, multiple myeloma, primary hyperparathyroidism, rheumatoid arthritis, Cushing's syndrome, or thyrotoxicosis
  • Suppressive doses of thyroid hormone, anticonvulsant drugs, past bisphosphonate therapy, current calcitonin therapy, or fluoride therapy
  • Cirrhosis, inflammatory liver disease, or nephrolithiasis
  • Serum creatinine \> 2.5 mg/dl

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Columbai University Medical Center

New York, New York, 10032, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

  • Shane E, Addesso V, Namerow PB, McMahon DJ, Lo SH, Staron RB, Zucker M, Pardi S, Maybaum S, Mancini D. Alendronate versus calcitriol for the prevention of bone loss after cardiac transplantation. N Engl J Med. 2004 Feb 19;350(8):767-76. doi: 10.1056/NEJMoa035617.

    PMID: 14973216BACKGROUND

MeSH Terms

Conditions

OsteoporosisBone Diseases, MetabolicFractures, Bone

Interventions

AlendronateCalcitriol

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesWounds and Injuries

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsDihydroxycholecalciferolsHydroxycholecalciferolsCholecalciferolCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Elizabeth Shane, MD

    Columbia University Department of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

September 1, 1997

Primary Completion

April 1, 2002

Study Completion

April 1, 2002

Last Updated

July 7, 2015

Record last verified: 2015-07

Locations

US(2)