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

NCT ID: NCT05372224

Last Updated: 2023-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-22
• Study Completion Date: 2021-06-22

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, discontinuation of denosumab produces a rapid increase in bone turnover, bone loss and potentially increased risk of multiple vertebral fractures.

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 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.

Conditions

Hypovitaminosis D; Osteoporosis, Postmenopausal; Menopause

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vitamin D 4000 IU

4000 IU of vitamin D were administrated once a day orally and calcium carbonate 1.2 g a day in a single dose.

Group Type: EXPERIMENTAL

Cholecalciferol

Intervention Type: DRUG

4000 IU were administrated once a day for 3 months.

Interventions

Cholecalciferol

4000 IU were administrated once a day for 3 months.

Intervention Type: DRUG

Other Intervention Names

Histofil®

Eligibility 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 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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universidad Nacional Autonoma de Mexico

OTHER

Sponsor Role: collaborator

National Polytechnic Institute, Mexico

OTHER

Sponsor Role: collaborator

Hospital Regional 1o de Octubre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

María B Brito-Gavilanes, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1 ISSSTE

Patricia Loranca-Moreno, M.D., M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE.

Juan M Ocampo-Godínez, M.D., P.hD

Role: PRINCIPAL_INVESTIGATOR

Laboratory of Tissue Engineering, UNAM

Locations

Patricia Loranca-Moreno

Mexico City, Gustavo A. Madero, Mexico

Countries

Mexico

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 19671655 (View on PubMed)

Takeuchi T, Tanaka Y, Soen S, Yamanaka H, Yoneda T, Tanaka S, Nitta T, Okubo N, Genant HK, van der Heijde D. Effects of the anti-RANKL antibody denosumab on joint structural damage in patients with rheumatoid arthritis treated with conventional synthetic disease-modifying antirheumatic drugs (DESIRABLE study): a randomised, double-blind, placebo-controlled phase 3 trial. Ann Rheum Dis. 2019 Jul;78(7):899-907. doi: 10.1136/annrheumdis-2018-214827. Epub 2019 Apr 29.

Reference Type: BACKGROUND

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Other Identifiers

032.2020

Identifier Type: -

Identifier Source: org_study_id