An interventional study of Cholecalciferol in Postmenopausal Osteoporosis, Postmenopause and Hyperparathyroidism, Secondary, sponsored by Hospital Regional 1o de Octubre. Completed at 1 site in Mexico. Open to female participants. Per ClinicalTrials.gov, last updated 2022-05-06.
Sponsored by Hospital Regional 1o de Octubre · Not applicable, Interventional, and Treatment
Recently, an increase in the prevalence of hyperparathyroidism and hypovitaminosis D in postmenopause women has been occurring in Mexico and the world. Chronic exposure to the parathyroid hormone (PTH) is catabolic for the bone, worsening the state of osteoporosis. However, it is unclear whether these conditions could significantly improve bone mineral density (BMD). In the present work, it was shown that the resolution of hyperparathyroidism in postmenopausal women improves osteoporosis.
This study was an open clinical trial conducted in Mexican women diagnosed with postmenopausal osteoporosis and hyperparathyroidism associated or not with hypovitaminosis D from the climacteric clinic of the regional hospital "1o de Octubre" of the Institute of Security and Social Services for State Workers (ISSSTE).
An integral clinical evaluation with PTH and vitamin D measurement was first done to determine the frequency of primary hyperparathyroidism and hypovitaminosis D. Likewise, a thyroid ultrasound was done. Then, 8000 IU of vitamin D were orally administrated for four weeks. Statical 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. To perform correlations, the Spearman correlation coefficient was used. 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.
334 studies on the registry are indexed under Osteoporosis, Postmenopausal; 28 are open to participants now.
This study's enrollment of 47 is below the median of 119 across 264 interventional studies indexed under Osteoporosis, Postmenopausal.
Browse Osteoporosis, Postmenopausal 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.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
8000 IU of vitamin D orally, once a day, for four weeks.
Drug: Cholecalciferol
Tablets of 4000 IU
Also known as: Histofil®
Number of Participants with Remission of Hyperparathyroidism
Clinical remission of hyperparathyroidism was evaluated after treatment.
Time frame: 4 weeks
Number of Participants with Remission of Hypovitaminosis D
Clinical remission of vitamin D deficiency or insufficiency were evaluated after treatment.
Time frame: 4 weeks.
Change from baseline hip T score at 4 weeks
Osteoporosis in the hip was determined by a T score greater than -2.5 and osteopenia was determined by a T score between -1 to -2.4.
Time frame: 4 weeks
Change from baseline lumbar spine T score at 4 weeks
Osteoporosis in the lumbar spine was determined by a T-score greater than -2.5 and osteopenia was determined by a T-score between -1 and -2.4.
Time frame: 4 weeks
Change from baseline general T score at 4 weeks
Osteoporosis was determined by a T-score greater than -2.5 either in the hip or in the lumbar spine and osteopenia was determined by a T-score between -1 and -2.4 either in the hip or in the lumbar spine.
Time frame: 4 weeks
Plan to share: No
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cholecalciferol
Osteoporosis, Postmenopausal →
Hospital Regional 1o de Octubre