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OsteoporosisPhase 3POSTOPNCT01377467

Denosumab for Prevention of Osteoporosis in Renal Transplant Recipients

A Phase 3 study testing Denosumab (Prolia) in people with Osteoporosis and Chronic Kidney Disease, run by Rudolf Wuethrich at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of the study is to examine the effect of denosumab on lumbar spine bone mineral density (BMD) after one year of treatment in newly transplanted renal allograft recipients. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Osteoporosis, Chronic Kidney Disease
What is being tested?
Denosumab (Prolia)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteSwitzerland
Study dates
Jun 2011to Oct 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Age <18 years
  • Rising creatinine after initial drop <200 micromol/l or creatinine >200 micromol/l at baseline
  • Evidence of early acute rejection, either suspected clinically and/or proven by biopsy
  • Presence of severe osteoporosis as evidenced by a T score <-4 at the hip, femoral neck or any of the 4 vertebrae L1 to L4
  • Evidence of severe hyper- or hypoparathyroidism (iPTH >800 ng/l or <10 ng/l)
  • Hypocalcemia (total calcium <1.8 mmol/l) or hypercalcemia (total calcium >2.7 mmol/l)
  • Steroid-free de novo immunosuppression scheme

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Division of Nephrology, University Hospital

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: A Phase 3, Investigator-initiated, Randomized, Open-label Single-center Study of the Effect of Denosumab on the Prevention of Bone Mineral Density Loss After Renal Transplantation

The primary objective of the study is to examine the effect of denosumab on lumbar spine bone mineral density (BMD) after one year of treatment in newly transplanted renal allograft recipients. Secondary endpoints include BMD changes at the total hip and the femoral neck, changes in body height, changes in bone mineral metabolism parameters, incidence of fractures, and allograft function at one year. Safety measurements include the occurrence of rejection episodes, infectious complications, graft loss and mortality.

  • Trial with medicinal product
Read the detailed description

Renal allograft recipients are at high risk to suffer a substantial loss of bone mineral density (BMD) within the first year after kidney transplantation. This loss of BMD correlates with an increased risk for the development of osteoporosis or worsening of pre-existing osteopenia/osteoporosis, heightening the risk for the subsequent occurrence of fractures. Renal allograft recipients are often treated with calcium and vitamin D preparations to prevent BMD loss. The addition of bisphosphonates can further improve BMD. However, bisphosphonates are potentially nephrotoxic and promote adynamic bone disease, and are therefore not regularly prescribed.

Receptor Activator of Nuclear factor- Kappa-B Ligand (RANKL) is a key molecule mediating development, activity, and survival of osteoclasts. Osteoporosis results in part from increased osteoclastic bone resorption, and therefore the inhibition of RANKL activity has become an obvious therapeutic strategy to prevent bone mineral density (BMD) loss and the development of osteoporosis.

The novel anti-osteoporotic drug denosumab (trade name Prolia®) is a fully human monoclonal antibody against RANKL. By inhibiting the development and the activity as well as reducing the survival of osteoclasts it decreases bone resorption and increases bone density.

The hypothesis of the present study is that denosumab has a beneficial effect on the loss of BMD in the first year after renal transplantation. The preservation of BMD is a surrogate parameter, generally predicting subsequent improvements in the occurrence rate of fractures. The hypothesis will be tested by studying the effect of denosumab on BMD in newly transplanted renal allograft recipients.

The purpose of the present trial is to study the effect of denosumab on BMD in kidney allograft recipients. The study participants will be treated for 1 year, receiving a total of 2 injections of the standard 60 mg dose at baseline and at 6 months.

Ninety sequential renal allograft recipients will be randomized 1:1 to receive two subcutaneous 60 mg denosumab injections within 14 days and 6 months following renal transplantation, or no treatment. All patients will also receive oral standard treatment with 1000 mg calcium plus 800 IU vitamin D.

Being tested
Denosumab (Prolia)
Keywords
Osteoporosis, Osteopenia, Denosumab, Transplantation, Kidney
Medical subject headings
Osteoporosis, Renal Insufficiency, Chronic, Bone Diseases, Metabolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Denosumab (Prolia)Drug

    Also called Prolia

    60 mg s.c. injection at baseline and after 6 months

Study groups in NCT01377467
Study groupRoleWhat they receive
DenosumabExperimental60 mg denosumab s.c. at baseline and after 6 months
Receives: Drug: Denosumab (Prolia)
ControlNo interventionNo treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change in BMD at the Total Lumbar Spine From Baseline to Month 12

    The total lumbar spine BMD was measured via Dual Energy X-ray Absorptiometry (DXA) and was expressed in g/cm2 hydroxylapatite

    Measured: Baseline and month 12

Secondary outcomes (7)

  1. Percent Change in BMD at the Total Hip From Baseline to Month 12

    The total hip BMD was measured via Dual Energy X-ray Absorptiometry (DXA) and was expressed in g/cm2 hydroxylapatite

    Measured: Baseline and month 12

  2. Percent Change in BMD at the Femoral Neck From Baseline to Month 12

    The total femoral neck BMD was measured via Dual Energy X-ray Absorptiometry (DXA) and was expressed in g/cm2 hydroxylapatite

    Measured: Baseline and month 12

  3. Percent Change in BMD at the Total Lumbar Spine From Baseline to Month 6

    The total lumbar spine BMD was measured via DXA and was expressed in g/cm2 hydroxylapatite.

    Measured: Baseline and month 6

  4. Percent Change in BMD at the Total Hip From Baseline to Month 6

    The total hip BMD was measured via DXA and was expressed in g/cm2 hydroxylapatite

    Measured: Baseline and month 6

  5. Percent Change in BMD at the Femoral Neck From Baseline to Month 6

    The femoral neck BMD was measured via DXA and was expressed in g/cm2 hydroxylapatite

    Measured: Baseline and month 6

  6. Beta-CTX at Baseline and Months 3, 6 and 12

    Blood concentrations of beta-CTX (microgram/L)

    Measured: baseline, month 3, month 6, and month 12

  7. P1NP at Baseline and Months 3, 6 and 12

    Blood concentrations of P1NP were measured in microgram/L

    Measured: baseline, month 3, month 6, and month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2011 (estimated)
  2. Study startJun 2011
  3. Primary completionMay 2015
  4. Study completionOct 2015

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01377467
Sponsor's protocol ID
UZH-NEP 2.1
Acronym
POSTOP
Status last verified
Apr 2016
First submitted
20 Jun 2011
Last updated
26 May 2016
Data monitoring committee
No
Individual data sharing
No

Publications

  • Bonani M, Frey D, Brockmann J, Fehr T, Mueller TF, Saleh L, von Eckardstein A, Graf N, Wuthrich RP. Effect of Twice-Yearly Denosumab on Prevention of Bone Mineral Density Loss in De Novo Kidney Transplant Recipients: A Randomized Controlled Trial. Am J Transplant. 2016 Jun;16(6):1882-91. doi: 10.1111/ajt.13692. Epub 2016 Feb 29.

    PubMed 26713403

  • Wajih Z, Karpe KM, Walters GD. Interventions for BK virus infection in kidney transplant recipients. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD013344. doi: 10.1002/14651858.CD013344.pub2.

    PubMed 39382091

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Denosumab (Prolia) in people with Osteoporosis and Chronic Kidney Disease, run by Rudolf Wuethrich at 1 site in Switzerland.

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 0 inclusion and 7 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: finished, as of the sponsor's last update on 26 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percent Change in BMD at the Total Lumbar Spine From Baseline to Month 12 (time frame: Baseline and month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01377467, which also lists 2 linked publications.

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 May 2016.

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