Overview

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

Status:
Completed
Trial end date:
2020-11-22
Target enrollment:
0
Participant gender:
Female
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hospital Regional 1o de Octubre
Collaborators:
National Polytechnic Institute, Mexico
Universidad Nacional Autonoma de Mexico
Treatments:
Cholecalciferol
Criteria
Inclusion Criteria:

- Diagnosis of postmenopausal osteoporosis or osteopenia in treatment with denosumab
60mg every six months plus calcium carbonate 1.2g/day + vitamin D 800IU/day.

- Diagnosis of hypovitaminosis D, with serum cholecalciferol values <30ng/dL.

Exclusion Criteria:

- Incomplete clinical records or clinical records.

- Age over 70 years.

- Diagnosis of secondary (hereditary) osteoporosis.

- History of prolonged use of steroids.

- Lack of adherence to medical treatment.

- Diagnosis of cancer.

- Diagnosis of depression.

- Diagnosis of Celiac disease or with the presence of alterations in intestinal
absorption.

- Allergies to any of the medications administered.