Frequency of Hyperparathyroidism in Postmenopausal Osteoporosis and Its Treatment

Not Applicable

Completed

• Conditions: Postmenopausal Osteoporosis; Postmenopause; Hypovitaminosis D; Hyperparathyroidism, Secondary; Hyperparathyroidism, Primary
• Interventions: Drug: Cholecalciferol

• Registration Number: NCT05347082
• Lead Sponsor: Hospital Regional 1o de Octubre

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-04-29
• Primary Completion: 2021-12-29
• Study Completion: 2022-02-20
• Status Verified: 2022-04
• Study First Submitted: 2022-04-17
• Study First Submitted QC: 2022-04-20
• Study First Posted: 2022-04-26
• Last Update Submitted: 2022-04-30
• Last Update Posted: 2022-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 47

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vitamin D	Cholecalciferol	8000 IU of vitamin D orally, once a day, for four weeks.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Remission of Hyperparathyroidism	4 weeks	Clinical remission of hyperparathyroidism was evaluated after treatment.
Number of Participants with Remission of Hypovitaminosis D	4 weeks.	Clinical remission of vitamin D deficiency or insufficiency were evaluated after treatment.
Change from baseline hip T score at 4 weeks	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.
Change from baseline lumbar spine T score at 4 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change from baseline general T score at 4 weeks	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.

Trial Locations

Locations (1)

Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE; 🇲🇽 Mexico City, Mexico