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Effect of Vitamin D and Denosumab on Bone Remodelling in Women With Postmenopausal Osteoporosis

NCT05372224 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2023-02-17

No results posted yet for this study

Summary

Denosumab is a monoclonal antibody against RANKL ligand, which is used as an alternative treatment for osteoporosis in patients who have a poor response to first-line antiresorptive therapy. However, discontinuation of denosumab produces a rapid increase in bone turnover, bone loss and potentially increased risk of multiple vertebral fractures.

Conditions

  • Hypovitaminosis D
  • Osteoporosis, Postmenopausal
  • Menopause

Interventions

DRUG

Cholecalciferol

4000 IU were administrated once a day for 3 months.

Sponsors & Collaborators

  • Universidad Nacional Autonoma de Mexico

    collaborator OTHER

  • National Polytechnic Institute, Mexico

    collaborator OTHER

  • Hospital Regional 1o de Octubre

    lead OTHER

Principal Investigators

  • María B Brito-Gavilanes, M.D. · Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1 ISSSTE

  • Patricia Loranca-Moreno, M.D., M.Sc. · Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE.

  • Juan M Ocampo-Godínez, M.D., P.hD · Laboratory of Tissue Engineering, UNAM

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
89 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-22
Primary Completion
2021-06-22
Completion
2021-06-22

Countries

  • Mexico

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 NCT05372224 on ClinicalTrials.gov