Clinical trial NCT05372224: Effect of Vitamin D and Denosumab on Bone Remodelling in Women With Postmenopausal Osteoporosis
Official title: Vitamin D Improves Osteoporosis in Postmenopausal Women With Denosumab Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypovitaminosis D
Osteoporosis, Postmenopausal
Menopause
Keywords: Vitamin D
Postmenopausal Osteoporosis
Denosumab
Hypovitaminosis D
Osteoporosis
Osteopenia
Lead sponsor: Hospital Regional 1o de Octubre
Sponsor class: OTHER
Collaborators: name: Universidad Nacional Autonoma de Mexico
name: National Polytechnic Institute, Mexico
First posted: 2022-05-12
Enrollment: 55
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 76 participants were considered from the climacteric clinic of the regional hospital "1o de Octubre" of the Institute of Security and Social Services for State Workers (ISSSTE), of which 23 presented elimination criteria, and 55 were included in the study.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of participants with hip T-score improvement at 12 months
timeFrame: 12 months
measure: Number of participants with lumbar spine T-score improvement at 12 months
timeFrame: 12 months
measure: Number of participants with osteoporosis of the hip at 12 months
timeFrame: 12 months
measure: Number of participants with osteoporosis of the lumbar spine at 12 months
timeFrame: 12 months
measure: Number of participants with osteopenia on the hip at 12 months
timeFrame: 12 months
measure: Number of participants with osteopenia of the lumbar spine at 12 months
timeFrame: 12 months
measure: Number of participants with normal hip T-score at 12 months
timeFrame: 12 months
measure: Number of participants with normal lumbar spine T-score at 12 months
timeFrame: 12 months
measure: Number of participants with improvement in serum levels of vitamin D at 12 months
timeFrame: 12 months
measure: Number of participants with clinical remission of hypovitaminosis D at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Number of participants with vitamin D sufficiency at 12 months
timeFrame: 12 months
measure: Number of participants with vitamin D insufficiency at 12 months
timeFrame: 12 months
measure: Number of participants with vitamin D deficiency at 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Patricia Loranca-Moreno
state: Gustavo A. Madero
Study officials:
affiliation: Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1 ISSSTE
name: María B Brito-Gavilanes, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE.
name: Patricia Loranca-Moreno, M.D., M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Laboratory of Tissue Engineering, UNAM
name: Juan M Ocampo-Godínez, M.D., P.hD
role: PRINCIPAL_INVESTIGATOR
References:
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