A Study to Evaluate Efficacy and Safety of Denosumab for Prevention and Treatment of Osteoporosis in 1st Time Liver Transplant Recipients.

Launched by ALBERT EINSTEIN HEALTHCARE NETWORK · Jan 14, 2020

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age \>=18 years old
• • First-time Liver transplant Recipients
• • All men, postmenopausal women and women with history of hysterectomy or tubal ligation
• • Patients who have not been treated with medications for Osteoporosis within the past 12 months before the liver transplant
• • Patients able and agreeable to follow up at out Institution for the duration of the study
• • Patients hospitalized for less than 45 consecutive days after the liver transplant surgery
• • Patients with GFR\>30ml/min (calculated by Cockcroft-Gault equation, see Table 3 for details)
• • Patients with corrected Calcium \>= 8.5
• • Patients with PTH intact levels WNL (as per lab values)
• • Patients with vit D\>=20; NOTE: patients with vit D \<20 will be treated with high dose Ergocalciferol 50,000 units daily and rechecked in 2 weeks
• • Patients with t-score \>=-3.5 at all sites checked by DEXA scan
• • Patients agree to sign an informed consent form to be in the study
• • Can be treated with denosumab or placebo within 3 months from the liver transplant date
• Exclusion Criteria:
• • Patients with previous transplants
• • Patients that are getting 2 simultaneous transplants, like combined kidney and liver transplants
• • Age \< 18 year old
• • Patients hospitalized for over 45 days after the liver transplant surgery
• • Patients with GFR\< 30ml/min
• • Patients with hypocalcemia defined as corrected calcium \< 8.5
• • Patients with extensive dental problems, previous hx of Osteonecrosis of the jaw (ONJ) and/or high risk for developing ONJ
• • Patients with current Hyperthyroidism
• • Patients with current Primary Hyperparathyroidism defined by the combination of elevated calcium and PTH intact levels
• • Patients with severe Osteoporosis as defined by t-score \<-3.5 at any site shown by DEXA scan
• • Women of reproductive age without history of tubal ligation or hysterectomy
• • Patients who cannot read or understand the Informed Consent Document or study instructions
• • Patients with diagnosis of dementia, or otherwise unable to give informed consent
• • Patients unable to follow up in our Institution for the duration of the study