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| Sponsor: | Hospital Clinic of Barcelona |
|---|---|
| Collaborator: |
Novartis |
| Information provided by: | Hospital Clinic of Barcelona |
| ClinicalTrials.gov Identifier: | NCT00657852 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bone Disease, Metabolic |
Drug: Disodium pamidronate Drug: Placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| 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 |
| Enrollment: | 79 |
| Study Start Date: | December 2000 |
| Study Completion Date: | December 2003 |
| Primary Completion Date: | December 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
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
|
|
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
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
|
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 metabolism.
Study Design and Conduct
The study will be a 1-year prospective, randomized, double-blind, placebo-controlled trial conducted at 10 centers in Spain.
Immunosuppression
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.
Intervention
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.
Study Endpoints
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 nonvertebral fractures.
Evaluation
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Spain | |
| Hospital Clinic i Provincial of Barcelona | |
| Barcelona, Spain, 08036 | |
| Principal Investigator: | Miquel Navasa, Dr | Hospital Clinic i Provincial, Barcelona |
More Information
| Responsible Party: | Digestive Diseases Institute, Hospital Clinic of Barcelona ( Dr. Miquel Navasa Anadón ) |
| Study ID Numbers: | 99-NV001 |
| Study First Received: | April 8, 2008 |
| Last Updated: | April 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00657852 History of Changes |
| Health Authority: | Spain: Spanish Agency of Medicines |
|
pamidronate,bone loss, liver transplantation |
|
Diphosphonates Metabolic Diseases Musculoskeletal Diseases Physiological Effects of Drugs Pamidronate |
Bone Density Conservation Agents Bone Diseases, Metabolic Bone Diseases Pharmacologic Actions |
