Fact CheckerSign in

NCT04208230Completed

Progression and Etiology of Cortical Porosity in Diabetic Bone Disease

Source: ClinicalTrials.gov · Last updated 18 Nov 2023

Brief summary (registry, in English)

Type 2 diabetes is associated with increased cortical bone porosity and increased fracture risk. The goal of this proposed study is to understand the longitudinal evolution of cortical bone porosity and to investigate the underlying biological processes that drive increased cortical porosity and fracture risk in the setting of diabetes. The investigators will apply novel techniques for in vivo imaging of cortical pores to patients with type 2 diabetes and controls in a longitudinal prospective study. This work will establish the longitudinal progression of cortical porosity and determine whether pore content can serve as a predictor of future cortical degradation and bone fragility.

Status (registry)
Completed
Study type
Observational
Enrollment
96 (actual)
First submitted
19 Dec 2019
Start date
3 Jan 2017
Primary completion date
31 Dec 2022
Lead sponsor
University of California, San Francisco
NCT number
NCT04208230

What you commit to

  • Study type: Observational
  • Participants enrolled: 96
  • From 3 Jan 2017 to the primary completion date, 31 Dec 2022
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Perimenopausal women, defined as last menses within previous 3 years
  • Current alcohol consumption (\>3 alcohol drinks/day), current illicit drug use.
  • Use of medications known to impact bone and mineral metabolism, including use of a bisphosphonate or teriparatide in the last year or for \>12 months ever, current calcitonin, prednisone \> 5mg daily or the equivalent glucocorticoid for \> 10 days in the last 3 months, current thiazolidinedione (TZD), thyroid hormone replacement with current thyroid stimulating hormone \< 0.1 miu/L. Patients undergoing hormone/testosterone replacement will NOT be excluded meaning they can be enrolled)
  • Trauma or surgery near radius or tibia imaging sites
  • An episode of immobilization lasting longer than 1 week in the previous 6 months

Other illness

  • Conditions excluded by x-ray or MRI safety guidelines

Lab values

  • History of metabolic bone disease other than post-menopausal bone loss. Persons with the following diseases: chronic gastrointestinal disease (including inflammatory bowel disease, celiac disease, or other malabsorptive disease including short-gut syndrome), renal or hepatic impairment (known cirrhosis or if transaminase levels 3 times the upper limit of normal)
  • Estimated Glomerular Filtration Rate (eGFR)\< 50 mL/min/1.73 m2 (baseline) or \< 40 (follow-up). The investigators will require eGFR ≥ 50 at baseline in an effort to avoid the possibility of an enrolled subject dropping below the established safety level of 40 at follow-up. This was determined knowing that eGFR can decline at a rate of approximately 4.0 per year in diabetics (much lower in non-diabetics).

Other

  • Body mass index greater than 40 as these subjects will be too large to fit into the gantry of the MR scanner or exceed weight limitations of the MR table

Who the study is looking for

  • Postmenopausal female and/or male
  • 50-70 years old
  • Body mass index (BMI) of 18-40
  • Subjects with bone mineral density of: 0 ≥ T-score \> -2.5
  • Additional requirement for type II diabetes patients:
    • Patients has a history of type II diabetes, as defined by the American Diabetes Association for more than 3 years. Patients must either have a documented HbA1C of 6.5 or higher for 3 or more years if they are not undergoing pharmacological treatment (diet controlled), or must have been receiving pharmacological treatment for the past 3 years.

Age in the registry: 50 years to 70 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of California San Francisco
Coordinator of this site? Confirm its status
San FranciscoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.