Who is sponsoring NCT03869281?

NCT03869281 is sponsored by Università Vita-Salute San Raffaele.

What drugs are being tested in NCT03869281?

Interventions in NCT03869281: Pancreas transplantation alone.

What condition does NCT03869281 study?

NCT03869281 studies Diabetes Mellitus, Type 1, Fractures, Bone.

Is NCT03869281 still recruiting?

NCT03869281 is currently completed. Last updated 29 December 2020.

Last reviewed 2020-12-29 · How we verify

NCT03869281: FRAPAT

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Fracture Risk After Pancreas Transplantation (FraPaT)

Completed Last updated 29 December 2020

What this trial tests

trial testing Pancreas transplantation alone in Diabetes Mellitus, Type 1 in 81 participants. Completed in 24 December 2020.

Timeline

7 December 2019

Primary endpoint
2 March 2020

24 December 2020

Quick facts

Lead sponsor	Università Vita-Salute San Raffaele
Status	Completed
Study type	OBSERVATIONAL
Enrollment	81
Start date	7 December 2019
Primary completion	2 March 2020
Estimated completion	24 December 2020
Sites	1 location across Italy

Drugs / interventions tested

Pancreas transplantation alone

Conditions studied

Diabetes Mellitus, Type 1 — all drugs for Diabetes Mellitus, Type 1 →
Fractures, Bone — all drugs for Fractures, Bone →

Sponsor

Università Vita-Salute San Raffaele — full company profile →

Who can join

Adults 18 to 64, any sex, with Diabetes Mellitus, Type 1 or Fractures, Bone. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Individuals with type 1 diabetes (T1D) are at greater risk of fracture than non-diabetic subjects. Although the mechanisms underlying bone fragility in T1D are not completely understood, insulin deficiency seems to play a key role. To date, no information is available on the effect of diabetes remission after pancreatic transplantation alone (PTA) on the risk of fractures in T1D individuals with preserved kidney function. The overall objective of this retrospective cohort study is to evaluate the effect of T1D remission after PTA on fracture risk. The primary endpoint will be the difference in fracture incidence (any fracture) between the PTA group and the control group. For the PTA group, the incidence of fractures after transplantation will be considered. Data from patients who underwent PTA at IRCCS San Raffaele Hospital from January 2, 2005 to December 31, 2017 will be compared with age-, gender- and disease duration-matched controls from the pool of outpatients with T1D attending the Endocrinology Unit at the same Institution. Anthropometric, anamnestic, laboratory data and data on the history of fractures and past/current therapies will be collected. With this study, for the first time we will be able to obtain information on the effects of diabetes remission on the risk of fracture. We expect that the remission of diabetes will result in a beneficial effect on the fracture risk.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Bone health in diabetes and prediabetes.
Costantini S, Conte C. · · 2019 · cited 54× · PMID 31523379 · DOI 10.4239/wjd.v10.i8.421

Verify or expand the search:

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Currently open trials in the same condition.

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Other Università Vita-Salute San Raffaele trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03869281 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Università Vita-Salute San Raffaele
Last refreshed: 29 December 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03869281.

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