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Therapy of the Skeletal Disease of Type 2 Diabetes With Denosumab

NCT03457818 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-07-03

Study results available
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Summary

The goal of the study is to characterize the effect of Prolia® (denosumab) on indices of bone strength in type 2 diabetes (T2D). The investigational plan involves administration of Prolia® or identical placebo for 12 months as a randomized double-blind placebo-controlled trial in 66 T2D postmenopausal women assigned to Prolia® or placebo. The study will include assessment of different measures of bone quality: skeletal microarchitecture, including measurement of skeletal cortical pores; bone mineral density; bone material quality, and accumulation of advanced glycation endproducts (AGEs) in collagen. This information will help to determine whether Prolia® treatment in type 2 diabetes has skeletal benefits.

Conditions

Interventions

DRUG

Denosumab 60 mg/ml [Prolia]

Denosumab 60 mg will be administered subcutaneously in the upper arm at the Baseline and 6 Month Visits

OTHER

Placebo

Placebo will be administered subcutaneously in the upper arm at the Baseline and 6 Month Visits

Sponsors & Collaborators

  • Mishaela Rubin

    lead OTHER

Principal Investigators

  • Mishaela Rubin, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-07
Primary Completion
2020-06-10
Completion
2020-06-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03457818 on ClinicalTrials.gov