An interventional study of Cholecalciferol in Hypovitaminosis D, Osteoporosis, Postmenopausal and Menopause, sponsored by Hospital Regional 1o de Octubre. Completed at 1 site in Mexico. Open to female participants aged 45 Years to 89 Years. Per ClinicalTrials.gov, last updated 2023-02-17.
Sponsored by Hospital Regional 1o de Octubre · Not applicable, Interventional, and Treatment
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.
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.
801 studies on the registry are indexed under Vitamin D Deficiency; 60 are open to participants now.
This study's enrollment of 55 is below the median of 78 across 590 interventional studies indexed under Vitamin D Deficiency.
Browse Vitamin D Deficiency studies →Hospital Regional 1o de Octubre is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
4000 IU of vitamin D were administrated once a day orally and calcium carbonate 1.2 g a day in a single dose.
Drug: Cholecalciferol
4000 IU were administrated once a day for 3 months.
Also known as: Histofil®
Number of participants with hip T-score improvement at 12 months
It refers to the number of participants who improved their hip T-score at three months after treatment.
Time frame: 12 months
Number of participants with lumbar spine T-score improvement at 12 months
It refers to the number of participants who improved their lumbar spine T-score at three months after treatment.
Time frame: 12 months
Number of participants with osteoporosis of the hip at 12 months
It refers to the number of participants that present a hip T-score above -2.5 three months after treatment.
Time frame: 12 months
Number of participants with osteoporosis of the lumbar spine at 12 months
It refers to the number of participants that present a lumbar spine T-score greater than -2.5 three months after treatment.
Time frame: 12 months
Number of participants with osteopenia on the hip at 12 months
It refers to the number of participants that present a hip T-score from -1 to -2.4 three months after treatment.
Time frame: 12 months
Number of participants with osteopenia of the lumbar spine at 12 months
It refers to the number of participants that present a lumbar spine T-score from -1 to -2.4 three months after treatment.
Time frame: 12 months
Number of participants with normal hip T-score at 12 months
It refers to the number of participants that present a hip T-score below -1 three months after treatment.
Time frame: 12 months
Number of participants with normal lumbar spine T-score at 12 months
It refers to the number of participants that present a lumbar spine T-score below -1 three months after treatment.
Time frame: 12 months
Number of participants with improvement in serum levels of vitamin D at 12 months
Improvement in serum levels of 25-hydroxy vitamin D \[25(OH)D\] was considered when serum vitamin D levels increased concerning baseline levels.
Time frame: 12 months
Number of participants with clinical remission of hypovitaminosis D at 12 months
Remission of hypovitaminosis D was considered when serum levels of 25-hydroxy vitamin D \[25(OH)D\] were above 29 pg/ml.
Time frame: 12 months
Number of participants with vitamin D sufficiency at 12 months
It refers to the number of participants who reached serum levels of vitamin D above 29 pg/ml after three months of treatment.
Time frame: 12 months
Number of participants with vitamin D insufficiency at 12 months
It refers to the number of participants who reached serum levels of vitamin D of 21 to 29 pg/ml after three months of treatment.
Time frame: 12 months
Number of participants with vitamin D deficiency at 12 months
It refers to the number of participants who reached serum levels of vitamin D less than 20 pg/ml after three months of treatment.
Time frame: 12 months
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cholecalciferol
Hospital Regional 1o de Octubre