OsteoporosisPhase 2NCT04231682
A Study to Evaluate Efficacy and Safety of Denosumab for Prevention and Treatment of Osteoporosis in 1st Time Liver Transplant Recipients.
A Phase 2 study testing Denosumab Injection in people with Osteoporosis, run by Albert Einstein Healthcare Network.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Denosumab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2020to 1 Jan 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
About this study
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
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.
- Conditions
- Osteoporosis
- Being tested
- Denosumab Injection, Placebos
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Denosumab InjectionDrug
Use of denosumab in post liver transplant patient for prevention and management of osteoporosis and bone loss.
PlacebosDrug
Use of placebo in post liver transplant patient for prevention and management of osteoporosis and bone loss.
| Study group | Role | What they receive |
|---|---|---|
| Denosumab receiving group. | Experimental | Patients in this arm will receive denosumab injection 60 mg subcutaneously every 6 months. (A total of 4 injections) Receives: Drug: Denosumab Injection |
| Placebo receiving group. | Placebo comparator | Patients in this arm will receive Placebo injection subcutaneously every 6 months. (A total of 4 injections) Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage changes in bone mass calculated by DEXA scan t-score of Lumbar Spine in the intervention and control groups at 12 months.
Measured: 12 months
Secondary outcomes (6)
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.
Measured: 12 months
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.
Measured: 24 months
The vertebral and non-vertebral fracture incidence at 12 and 24 months.
Measured: 12 and 24 months
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.
Measured: 6, 12, 18 and 24 months
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.
Measured: 6, 12, 18 and 24 months
The percentage of patients developing infections, rejection episodes, hospitalizations or ED visits during the study period.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 Jul 2020 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Why it stopped: Grant support was withdrawn from Amgen Pharmaceuticals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein Healthcare Network
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Principal investigator, Catherine Anastasopoulou, MD, PhD, FACE, Albert Einstein Healthcare Network
- Investigators
- Catherine Anastasopoulou, MD, PhD, Principal investigator, Einstein Medical Center Philadelphia.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231682
- Sponsor's protocol ID
- IRB-2020-300
- Status last verified
- Jun 2020
- First submitted
- 3 Jan 2020
- Last updated
- 26 Jun 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04231682
- Acronym / sponsor ID
- IRB-2020-300
- Conditions
- Osteoporosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Grant support was withdrawn from Amgen Pharmaceuticals
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Albert Einstein Healthcare NetworkUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Denosumab receiving group. | Experimental | Drug: Denosumab InjectionPatients in this arm will receive denosumab injection 60 mg subcutaneously every 6 months. (A total of 4 injections) |
| Placebo receiving group. | Placebo comparator | Drug: PlacebosPatients in this arm will receive Placebo injection subcutaneously every 6 months. (A total of 4 injections) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Denosumab InjectionUse of denosumab in post liver transplant patient for prevention and management of osteoporosis and bone loss. | Drug | Denosumab receiving group. |
| PlacebosUse of placebo in post liver transplant patient for prevention and management of osteoporosis and bone loss. | Drug | Placebo receiving group. |
Primary outcome
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
6 secondary outcomes
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
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
The vertebral and non-vertebral fracture incidence at 12 and 24 months.
Time frame: 12 and 24 months
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
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
The percentage of patients developing infections, rejection episodes, hospitalizations or ED visits during the study period.
Time frame: 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Anastasopoulou, MD, PhD principal investigator
Einstein Medical Center Philadelphia.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Denosumab Injection in people with Osteoporosis, run by Albert Einstein Healthcare Network.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2020.