Frequency of Hyperparathyroidism in Postmenopausal Osteoporosis and Its Treatment

Hospital Regional 1o de Octubre

Status: Completed

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

Treatments: Drug: Cholecalciferol

Study type: Interventional

Funder types: Other

Identifiers

NCT05347082

120.2021

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 47 patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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47 participants in 1 patient group

Vitamin D

Experimental group

Description:

8000 IU of vitamin D orally, once a day, for four weeks.

Treatment:

Drug: Cholecalciferol