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Comparative Effect of Zoledronic Acid Versus Denosumab on Serum Sclerostin of Postmenopausal Women With Low Bone Mass

NCT01572545 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2013-01-17

No results posted yet for this study

Summary

The primary aim of the study is the comparative effect of zolendronic acid versus denosumab on serum sclerostin levels in postmenopausal women with low bone mass.

Secondary aims are their comparative effect on serum dickkopf-1, osteoprotegerin, receptor activator of nuclear factor kappaB ligand (RANKL) and bone turnover markers (procollagen type I N-terminal peptide \[PINP\] and C-terminal cross-linking telopeptide of type I collagen \[CTX\]).

Conditions

  • Postmenopausal Osteoporosis

Interventions

DRUG

Denosumab

Denosumab (injection), 60 mg, administered as a single subcutaneous injection once

DRUG

Zoledronic acid

Zoledronic acid (vial), 5 mg, administered once as a single 15- to 30-minute intravenous infusion

Sponsors & Collaborators

  • 424 General Military Hospital

    collaborator OTHER

  • 251 Hellenic Air Force & VA General Hospital

    collaborator OTHER

  • Aristotle University Of Thessaloniki

    lead OTHER

Principal Investigators

  • Stergios A Polyzos, MD, MSc, PhD · Aristotle University Of Thessaloniki

  • Athanasios D Anastasilakis, MD, PhD · 424 General Military Hospital

  • Polyzois Makras, MD, PhD · 251 Hellenic Air Force & VA General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2012-09-30
Completion
2013-01-31

Countries

  • Greece

Study Locations

More Related Trials

Entities

Drugs

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 NCT01572545 on ClinicalTrials.gov