Frequency of Hyperparathyroidism in Postmenopausal Osteoporosis and Its Treatment

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Resolution of Hyperparathyroidism With High-dose Vitamin D Improves Osteoporosis in Multi-treated Postmenopausal Women

Conditions
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Postmenopausal Osteoporosis, Postmenopause, Hyperparathyroidism, Secondary, Hypovitaminosis D, Hyperparathyroidism, Primary

Intervention / Treatment
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* Drug: Cholecalciferol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acceptance to participate in the study with informed consent. Postmenopausal osteoporosis or osteopenia. Primary or secondary hyperparathyroidism. Insufficiency or deficiency of vitamin D. Multi-treated postmenopausal osteoporosis. Postmenopausal osteoporosis without treatment. Exclusion Criteria: Different osteoporosis aetiology not related to oestrogenic deficiency. Thyroid pathology. Previous treatment with vitamin D, thiazide diuretics, lithium, Teriparatide or glucocorticoids. Known allergies to vitamin D. Addison's disease, pheochromocytoma, and depressive disorders.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 47 participants who met the inclusion criteria were included and all received 8000 IU of vitamin D orally for four weeks.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D<br>8000 IU of vitamin D orally, once a day, for four weeks. | Drug: Cholecalciferol<br>* Tablets of 4000 IU<br>* Other names: Histofil®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Remission of Hyperparathyroidism | Clinical remission of hyperparathyroidism was evaluated after treatment. | 4 weeks | 
| Number of Participants with Remission of Hypovitaminosis D | Clinical remission of vitamin D deficiency or insufficiency were evaluated after treatment. | 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. | 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. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D, Postmenopause, Osteopenia, Osteoporosis, Bone Mineral Density, Hyperparathyroidism