Status:
COMPLETED
Effect of Vitamin D and Denosumab on Bone Remodelling in Women With Postmenopausal Osteoporosis
Lead Sponsor:
Hospital Regional 1o de Octubre
Collaborating Sponsors:
Universidad Nacional Autonoma de Mexico
National Polytechnic Institute, Mexico
Conditions:
Hypovitaminosis D
Osteoporosis, Postmenopausal
Eligibility:
FEMALE
45-89 years
Phase:
NA
Brief 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, ...
Detailed Description
76 postmenopausal women from the climacteric clinic of the regional hospital "1o de Octubre" of the Institute of Security and Social Services for State Workers (ISSSTE) were firstly considered, of whi...
Eligibility Criteria
Inclusion
- 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
- Incomplete clinical records or clinical records.
- Age over 90 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.
Key Trial Info
Start Date :
June 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 22 2021
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT05372224
Start Date
June 22 2020
End Date
June 22 2021
Last Update
February 17 2023
Active Locations (1)
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1
Patricia Loranca-Moreno
Mexico City, Gustavo A. Madero, Mexico, 07300