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.