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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04231682
Recruitment Status : Withdrawn (Grant support was withdrawn from Amgen Pharmaceuticals)
First Posted : January 18, 2020
Last Update Posted : June 26, 2020
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Catherine Anastasopoulou, MD, PhD, FACE, Albert Einstein Healthcare Network

Brief Summary:
Organ transplant recipients are known to suffer from bone loss and subsequent fractures after the transplant operation with the most rapid bone loss occurring within the first 3-12 months. Guidelines for prevention and treatment of this serious complication are only written by individual medical societies interested in each organ (separate kidney from liver or heart transplants management) and they are based on studies done with limited medications choices. The majority of studies are done with the use of bisphosphonates, and there are very limited, or no data, on the effect of other medications used for Osteoporosis, including the use of denosumab. This study will focus on the evaluation of the efficacy and safety of denosumab 60mg use early (within first 3 months) after Liver Transplantation in the management of bone loss and prevention of fragility fractures. Different tests will be used to study the effect of the medication on the skeleton, including imaging studies as well as specific labwork.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Denosumab Injection Drug: Placebos Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Prospective Randomized Double-Blind, Placebo-Controlled Phase 2 Study Evaluating the Efficacy and Safety of Early Administration of Denosumab 60mg for Prevention and Treatment of Osteoporosis in First-time Liver Transplant Recipients
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : January 1, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Denosumab

Arm Intervention/treatment
Experimental: Denosumab receiving group.
Patients in this arm will receive denosumab injection 60 mg subcutaneously every 6 months. (A total of 4 injections)
Drug: Denosumab Injection
Use of denosumab in post liver transplant patient for prevention and management of osteoporosis and bone loss.

Placebo Comparator: Placebo receiving group.
Patients in this arm will receive Placebo injection subcutaneously every 6 months. (A total of 4 injections)
Drug: Placebos
Use of placebo in post liver transplant patient for prevention and management of osteoporosis and bone loss.




Primary Outcome Measures :
  1. The percentage changes in bone mass calculated by DEXA scan t-score of Lumbar Spine in the intervention and control groups at 12 months. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. The percentage changes in bone mass calculated by DEXA scan t-score of Femoral Neck, Total Hip and Wrist in the intervention and control groups at 12 months. [ Time Frame: 12 months ]
  2. The percentage changes in bone mass calculated by DEXA scan t-score of Lumbar Spine, Femoral Neck, Total Hip and Wrist in the intervention and control groups at 24 months. [ Time Frame: 24 months ]
  3. The vertebral and non-vertebral fracture incidence at 12 and 24 months. [ Time Frame: 12 and 24 months ]
  4. The percentage changes of biochemical markers of variables of bone turnover (BSAP, CTX and PINP) from baseline to 6, 12, 18 and 24 months after 1st medication administration. [ Time Frame: 6, 12, 18 and 24 months ]
  5. The percentage changes of creatinine, Calcium, Magnesium, Phosphorus, PTH intact and 25-Vit D levels from baseline to 6, 12, 18 and 24 months after the 1st medication administration. [ Time Frame: 6, 12, 18 and 24 months ]
  6. The percentage of patients developing infections, rejection episodes, hospitalizations or ED visits during the study period. [ Time Frame: 24 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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): NCT04231682


Sponsors and Collaborators
Albert Einstein Healthcare Network
Amgen
Investigators
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Principal Investigator: Catherine Anastasopoulou, MD, PhD Einstein Medical Center Philadelphia.
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Responsible Party: Catherine Anastasopoulou, MD, PhD, FACE, Attending Physician, Diabetes and Endocrinology., Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier: NCT04231682    
Other Study ID Numbers: IRB-2020-300
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: June 26, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Denosumab
Bone Density Conservation Agents
Physiological Effects of Drugs