Efficacy of Pamidronate in the Treatment of Bone Loss Associated With Liver Transplant
Information source: Hospital Clinic of Barcelona
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bone Disease, Metabolic
Intervention: Disodium pamidronate (Drug); Placebo (Drug)
Phase: Phase 4
Sponsored by: Hospital Clinic of Barcelona
Official(s) and/or principal investigator(s):
Miquel Navasa, Dr, Principal Investigator, Affiliation: Hospital Clinic i Provincial, Barcelona
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.
Official title: Prospective, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy of Disodium Pamidronate in the Treatment of Bone Loss Associated With Liver Transplant
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: bone mineral density (BMD), quantified by dual energy X-ray absorptiometry (DXA)
incidence of skeletal fractures, by assessment of radiological vertebral fractures (symptomatic and asymptomatic),
incidence of nonvertebral fractures
Patients diagnosed with chronic advanced liver disease awaiting orthotopic liver
transplantation will be eligible to take part in this study.
Patients excluded from the study will be those younger than 18 years, those receiving a
multiorgan transplant or retransplant, or patients with a previous allergy to
bisphosphonates. Previous treatment with fluoride, estrogens, selective estrogen receptor
modulators or bisphosphonates will be another reason for exclusion, as well as therapy with
glucocorticoids during the last 6 months before transplantation. None of the patients will
have a previous history of disorders, other than liver disease, known to affect bone
Study Design and Conduct
The study will be a 1-year prospective, randomized, double-blind, placebo-controlled trial
conducted at 10 centers in Spain.
All patients will receive microemulsion cyclosporine A (CsA) as primary immunosuppressive
agent, in combination with glucocorticoids. Additionally, mycophenolate mofetil will be
associated according to the usual clinical practice of each center. In all cases,
glucocorticoids will be progressively tapered during the first year.
Patients will receive oral calcium (500 mg twice daily) and oral 25-hydroxy vitamin D (16000
UI every 15 days), after informed consent for the study will be obtained and exploratory
screening will be done. Within days 7-12 after engraftment, the recruited transplanted
patients (will be randomized to either the experimental or placebo group. Patients of the
treatment group will receive a 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. Patients of the placebo group will
receive 500 ml of 5% glucoside serum infusions. Treatment with oral calcium and vitamin D
will be maintained for 1 year after transplantation.
The primary endpoints of the study will be changes in bone mineral density (BMD), quantified
by dual energy X-ray absorptiometry (DXA) and safety of pamidronate by recording adverse
events. Secondary endpoints will include the incidence of skeletal fractures, by assessment
of radiological vertebral fractures (symptomatic and asymptomatic), and the development of
Five study visits will be scheduled: before transplantation, within day 7-12 after liver
transplantation and at 3, 6 and 12 months after liver transplantation.
Minimum age: 18 Years.
Maximum age: N/A.
- diagnosed with chronic advanced liver disease awaiting orthotopic liver
- younger than 18 years
- receiving a multiorgan transplant or retransplant
- previous allergy to bisphosphonates
- Previous treatment with fluoride, estrogens, selective estrogen receptor modulators
- therapy with glucocorticoids during the last 6 months before transplantation
- previous history of disorders, other than liver disease, known to affect bone
Locations and Contacts
Hospital Clinic i Provincial of Barcelona, Barcelona 08036, Spain
Starting date: December 2000
Last updated: April 8, 2008