Health TrialsbyHealthPanel

The Impact of Glomerular Disorders on Bone Quality and Strength

ConditionsGlomerular DiseaseBone Diseases, MetabolicBone Fracture
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-55
SponsorColumbia University

About this trial

The primary objectives of this study are to: (1) determine the impact of glomerular disease on bone strength and (2) investigate the pathophysiologic underpinnings of impaired bone strength in glomerular disease.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

CureGN participant or CureGN Eligible

First diagnostic kidney biopsy within 5 years of CureGN study enrollment

Access to first kidney biopsy report and/or slides or not being interested in study participation.

Males or females 5 to 55 years (premenopausal for women)

Disqualifiers

Chronic Dialysis

Solid organ transplantation

Lower extremity amputations or non-ambulatory

Malignancy requiring chemotherapy or metastatic to bone

Trial population

Prospective cohort study of 150 CureGN participants (100 adults/50 children) will be evaluated at baseline and 12 months. The CureGN DCC at Arbor Research will identify CureGN participants eligible for inclusion. Recruitment of healthy participants will also occur by leveraging the services of the CHOP Recruitment Enhancement Core (REC), Pediatric Research Consortium (PeRC) and the RecruitMe tool provided by the Clinical Trials Office at CUMC. Healthy adult controls will be recruited from patients who receive outpatient care within the Penn Primary Care Networks, Penn employees and students, an extensive database of individuals who have participated in prior research studies at Penn and through local advertising on the Penn campus.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Dual-energy X-ray absorptiometry

    Radiation

    DXA whole body, hip, spine, and radius at baseline, and 12-month visit.

  • High Resolution Peripheral Quantitative Computed Tomography (HR-pQCT)

    Radiation

    HR-pQCT of the radius and tibia at baseline, and 12-month visit.

  • Blood draw and Urine collection

    Other intervention

    The blood draw can be completed +/- 3 weeks from baseline or 12-month visit.

  • Questionnaires

    Other intervention

    Questionnaires regarding fracture history, physical activity and dietary intake at baseline, and 12-month visit.

Treatment groups

270 Participants
are divided into 1 treatment group
Group A: BoneGN participants4 interventions

Trial outcomes

Primary outcomes

1

Change in radius bone strength (failure load)

HR-pQCT will be used to assess bone microarchitecture and generate micro-finite element analysis (µFEA)-based estimates of bone strength.

Time frame
Baseline and 12 months
2

Change in tibia bone strength (failure load)

HR-pQCT will be used to assess bone microarchitecture and generate micro-finite element analysis (µFEA)-based estimates of bone strength.

Time frame
Baseline and 12 months

Secondary outcomes

1

Radius mid-shaft failure load

Measured with HR-pQCT

Time frame
Up to 12 months
2

Tibia mid-shaft failure load

Measured with HR-pQCT

Time frame
Up to 12 months
3

Cortical density of radius

Measured with HR-pQCT

Time frame
Up to 12 months
4

Cortical density of tibia

Measured with HR-pQCT

Time frame
Up to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Columbia University

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov
Apply now