The Effect of Zoledronic Acid on Bone Density in Liver Transplant Patients
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ClinicalTrials.gov Identifier: NCT00114556 |
Recruitment Status :
Completed
First Posted : June 16, 2005
Last Update Posted : May 9, 2006
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Following liver transplantation, rapid bone loss occurs, particularly within the first 6 months post-transplant. This may be associated with fractures, most notable vertebral. The ability to assess osteoporosis therapies in this system may provide useful information for osteoporosis management in general.
Hypotheses:
- That treatment with the bisphosphonate, zoledronate, at the time of liver transplantation and at 1 month post-transplantation will prevent the early transplant-related bone loss (measured by bone densitometry and biochemical bone markers at 3 months) seen in patients who are not treated with a bisphosphonate
- That continuing treatment with zoledronate at 3 monthly intervals for a total duration of 12 months will result in further improvements in bone density beyond that seen at 3 months
- That calcium and vitamin D (vit D) supplementation of liver transplant patients does not prevent marked bone loss following transplantation.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteoporosis Liver Transplantation Fractures | Drug: zoledronic acid | Phase 4 |

Study Type : | Interventional (Clinical Trial) |
Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Double |
Primary Purpose: | Prevention |
Official Title: | The Effect Of The Bisphosphonate, Zoledronic Acid, On Bone Density In Liver Transplant Patients - A Prospective, Randomised, Controlled Clinical Trial |
Study Start Date : | February 2000 |
Study Completion Date : | August 2004 |

- bone density
- bone turnover markers

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Ages Eligible for Study: | 17 Years to 70 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Greater than 17 years of age
Exclusion Criteria:
- Concurrent treatment, or within the past 12 months, with drugs known to affect bone metabolism
- Hypocalcemia
- Renal impairment (creatinine >1.5x ULN)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00114556
Australia, New South Wales | |
Royal Prince Alfred Hospital | |
Sydney, New South Wales, Australia, 2050 |
Principal Investigator: | Geoffrey McCaughan, PhD, MB BS | Royal Prince Alfred Hospital, Sydney, Australia |
Other Publications:
ClinicalTrials.gov Identifier: | NCT00114556 |
Other Study ID Numbers: |
CZOL446 AU02 |
First Posted: | June 16, 2005 Key Record Dates |
Last Update Posted: | May 9, 2006 |
Last Verified: | December 2004 |
osteoporosis liver transplantation |
Osteoporosis Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |
Metabolic Diseases Zoledronic Acid Bone Density Conservation Agents Physiological Effects of Drugs |