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

Hospital Regional 1o de Octubre

Status

Completed

Conditions

Menopause

Hypovitaminosis D

Osteoporosis, Postmenopausal

Treatments

Drug: Cholecalciferol

Study type

Interventional

Funder types

Other

Identifiers

NCT05372224

032.2020

Details and patient eligibility

About

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.

Full 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 which 23 presented elimination criteria and only 55 who had received denosumab therapy for an average of 2.5 years without a significant improvement in hip and lumbar spine T-scores were enrolled. First, a general medical evaluation was performed. Serum levels of vitamin D were analysed to find the prevalence of hypovitaminosis D. A bone mineral density test was done to calculate hip and lumbar spine T-scores. Then, vitamin D was administrated daily for one year at a dose of 4,000 IU and the studies were repeated after one year. Statistical analysis was performed using PAST 3.0 and GraphPad Prism 8.4.3. software. The arithmetic median (µ) and standard deviation (S.D.) were calculated using Excel-Word. Graphics were constructed with GraphPad Prism 8.4.3 and tables with Excel Word. Categorical variables were analysed with chi-squared or Fisher exact test depending on the number of participants in each cell. Normality was determined using the Shapiro-Wilk test. To compare two paired samples, the Wilcoxon signed-rank test was utilized. The assigned α value for this study was <0.05. In all cases, if a Montecarlo permutation was available, the exact p-value was taken instead of the raw p-value.

Enrollment

55 patients

Sex

Female

Ages

45 to 89 years old

Volunteers

No Healthy Volunteers

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 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.