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Completed

NCT Number: NCT05347082

Frequency of Hyperparathyroidism in Postmenopausal Osteoporosis and Its 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.

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Key information

Conditions

Postmenopausal Osteoporosis Avitaminosis Bone Diseases Bone Diseases, Metabolic Deficiency Diseases Endocrine System Diseases Hyperparathyroidism Hyperparathyroidism, Primary Hyperparathyroidism, Secondary Hypovitaminosis D Malnutrition Metabolic Diseases Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal Parathyroid Diseases Postmenopause Vitamin D Deficiency

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE

Mexico City, 07300, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cholecalciferol

Drug

Tablets of 4000 IU

Other names: Histofil®

Primary outcomes

  1. Number of Participants with Remission of Hyperparathyroidism

    Time frame: 4 weeks

    Clinical remission of hyperparathyroidism was evaluated after treatment.

  2. Number of Participants with Remission of Hypovitaminosis D

    Time frame: 4 weeks.

    Clinical remission of vitamin D deficiency or insufficiency were evaluated after treatment.

  3. Change from baseline hip T score at 4 weeks

    Time frame: 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. Change from baseline lumbar spine T score at 4 weeks

    Time frame: 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 outcomes

  1. Change from baseline general T score at 4 weeks

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospital Regional 1o de Octubre

Other

Collaborators

  • National Polytechnic Institute, Mexico
  • Universidad Nacional Autonoma de Mexico

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Apr 26, 2022
Registry last updated
May 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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