Frequency of Hyperparathyroidism in Postmenopausal Osteoporosis and Its Treatment

Postmenopausal Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05347082
• Other study ID #: 120.2021
• Status: Completed
• Phase: N/A
• Start date: April 29, 2021
• Est. completion date: February 20, 2022

Study information

• Verified date: April 2022
• Source: Hospital Regional 1o de Octubre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: February 20, 2022
• Est. primary completion date: December 29, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Avitaminosis
• Hyperparathyroidism
• Hyperparathyroidism, Primary
• Hyperparathyroidism, Secondary
• Hypovitaminosis D
• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporosis
• Postmenopause
• Rickets
• Vitamin D Deficiency

Intervention

Drug:
• Cholecalciferol
Tablets of 4000 IU

Locations

Country	Name	City	State
Mexico	Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE	Mexico City

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Regional 1o de Octubre	National Polytechnic Institute, Mexico, Universidad Nacional Autonoma de Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (23)

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Yuan F, Peng W, Yang C, Zheng J. Teriparatide versus bisphosphonates for treatment of postmenopausal osteoporosis: A meta-analysis. Int J Surg. 2019 Jun;66:1-11. doi: 10.1016/j.ijsu.2019.03.004. Epub 2019 Mar 16. Review. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Remission of Hyperparathyroidism	Clinical remission of hyperparathyroidism was evaluated after treatment.	4 weeks
Primary	Number of Participants with Remission of Hypovitaminosis D	Clinical remission of vitamin D deficiency or insufficiency were evaluated after treatment.	4 weeks.
Primary	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
Primary	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	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