Zoledronic Acid Versus Alendronate for Prevention of Bone Loss After Organ Transplantation (CTX)

Columbia University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Liver Transplantation; Heart Transplantation; Bone Resorption

Treatments: Drug: Zoledronic acid; Other: Placebo Alendronate; Other: Placebo Zoledronic Acid; Drug: Alendronate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00297830

CZOL446H104 (Other Identifier)

AAAB2324

Details and patient eligibility

About

The purpose of this study is to compare the effectiveness and safety of zoledronic acid with alendronate in the prevention of bone loss after organ transplantation. Zoledronic acid is given as a single intravenous infusion. Alendronate is given as a weekly pill. Both are expected to be very effective, but it is not known which one will work best.

Full description

Patients who have undergone heart or liver transplantation are usually required to remain on medications, such as Prednisone and Cyclosporine A or Tacrolimus, that prevent the body from rejecting the transplanted organ. These medications may cause bone loss which leads to thinning of the bones (osteoporosis) and therefore greatly increase the risk of having broken bones (fractures) after transplantation. Several published studies have shown that 14% to 35% of heart transplant patients develop fractures (spine, ribs and hip) during the first year after transplantation. We have previously shown that alendronate (Fosamax), a drug approved by the FDA for prevention and treatment of postmenopausal osteoporosis and prednisone-induced osteoporosis, prevents bone loss after heart transplantation. We are conducting this study to determine whether a newer drug, zoledronic acid, is as effective as alendronate.

This study is a randomized, double-blind, placebo-controlled 2-year study. Participants will receive one dose of active zoledronic acid during the first month after heart or liver transplantation and weekly placebo alendronate pills or one dose of placebo zoledronic acid and weekly active alendronate pills for the first year after transplant. Over 2 years, participants will provide blood samples on nine occasions. Bone density will be performed 4-5 times and spine xrays will be performed twice.

Enrollment: 111 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A man or woman, aged 20 to 70, of any race who has had a heart or liver transplant

Exclusion criteria

• hyperparathyroidism
• Paget's disease
• hyperthyroidism
• cancer
• severe kidney disease,
• intestinal disease
• active peptic ulcer disease
• current or past treatment for osteoporosis
• pregnancy or lactation
• severe oral/dental disease

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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111 participants in 2 patient groups

Active Zoledronic Acid & Placebo Alendronate

Experimental group

Description:

Group 1 will receive an infusion of active zoledronic acid 5 mg during the first 4 weeks after transplantation. Placebo alendronate 70 mg once weekly will be initiated at the same time as the first zoledronic acid infusion.

Treatment:

Other: Placebo Alendronate

Drug: Zoledronic acid

Placebo Zoledronic Acid & Active Alendronate

Experimental group

Description:

Group 2 will receive an infusion of placebo zoledronic acid during the first 5 weeks after transplantation. Active alendronate 70 mg once weekly will be initiated at the same time as the placebo infusion.

Treatment:

Other: Placebo Zoledronic Acid

Drug: Alendronate