Efficacy of Pamidronate in the Treatment of Bone Loss Associated With Liver Transplant

NCT00657852 | Completed Phase 4

• 1 other identifier: 99-NV001
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of this study are to prospectively evaluate the efficacy of two intravenous infusions of pamidronate 90 mg, associated with calcium and calcidiol, in the early post-transplant period, on bone loss in liver transplant recipients, and to asses the safety of this treatment.

Conditions

Bone Disease, Metabolic

Keywords

pamidronate,bone loss, liver transplantation

Outcome Measures

Primary Outcomes (1)

• bone mineral density (BMD), quantified by dual energy X-ray absorptiometry (DXA)

  Change during the 1-year of follow up

Secondary Outcomes (3)

• adverse events

  incidence during 1-year of follow-up

• incidence of skeletal fractures, by assessment of radiological vertebral fractures (symptomatic and asymptomatic),

  1-year of follow-up

• incidence of nonvertebral fractures

  1-year follow-up

Study Arms (2)

Pamidronate

EXPERIMENTAL

Single dose of 90 mg disodium pamidronate within days 7-12 and at 3 months after liver transplantation, diluted in 500 ml of 5% glucose serum and administered as a 4-hour continuous intravenous infusion

Drug: Disodium pamidronate

Placebo

PLACEBO COMPARATOR

500 ml of 5% glucoside serum infusions within days 7-12 and at 3 months after liver transplantation and administered as a 4-hour continuous intravenous infusion

Drug: Placebo

Interventions

Disodium pamidronate DRUG

Single dose of 90 mg disodium pamidronate within days 7-12 and at 3 months after liver transplantation, diluted in 500 ml of 5% glucose serum and administered as a 4-hour continuous intravenous infusion

Also known as: Aredia

Pamidronate

Placebo DRUG

500 ml of 5% glucoside serum infusions within days 7-12 and at 3 months after liver transplantation and administered as a 4-hour continuous intravenous infusion

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed with chronic advanced liver disease awaiting orthotopic liver transplantation

You may not qualify if:

• younger than 18 years
• receiving a multiorgan transplant or retransplant
• previous allergy to bisphosphonates
• Previous treatment with fluoride, estrogens, selective estrogen receptor modulators or bisphosphonates
• therapy with glucocorticoids during the last 6 months before transplantation
• previous history of disorders, other than liver disease, known to affect bone metabolism.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead
• Novartis: collaborator

Study Sites (1)

Hospital Clinic i Provincial of Barcelona

Barcelona, Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Pamidronate

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Officials

• Miquel Navasa, Dr

  Hospital Clinic i Provincial, Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 8, 2008
• First Posted: April 14, 2008
• Study Start: December 1, 2000
• Primary Completion: December 1, 2003
• Study Completion: December 1, 2003
• Last Updated: April 14, 2008

Record last verified: 2008-04

Locations

ES (1)