Frequency of Hyperparathyroidism in Postmenopausal Osteoporosis and Its Treatment

Sponsor

Hospital Regional 1o de Octubre (Other)

Overall Status

Completed

CT.gov ID

NCT05347082

Collaborator

Universidad Nacional Autonoma de Mexico (Other), National Polytechnic Institute, Mexico (Other)

Enrollment

Location

Arm

9.8

Actual Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postmenopausal Osteoporosis Postmenopause Hyperparathyroidism, Secondary Hypovitaminosis D Hyperparathyroidism, Primary	Drug: Cholecalciferol	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

47 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

47 participants who met the inclusion criteria were included and all received 8000 IU of vitamin D orally for four weeks.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)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 29, 2021

Actual Primary Completion Date :

Dec 29, 2021

Actual Study Completion Date :

Feb 20, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vitamin D 8000 IU of vitamin D orally, once a day, for four weeks.	Drug: Cholecalciferol Tablets of 4000 IU Other Names: Histofil®

Arm

Intervention/Treatment

Experimental: Vitamin D

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

Drug: Cholecalciferol

Tablets of 4000 IU

Other Names:

Histofil®

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE	Mexico City		Mexico	07300

Sponsors and Collaborators

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

Investigators

Study Director: Juan M Ocampo Godínez, M.D., Ph.D., Tissue Bioengineering Laboratory, National Autonomous University of Mexico [UNAM]
Study Director: Patricia Loranca-Moreno, M.D., M.Sc., Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE.
Principal Investigator: Paula M Sánchez-Tinoco, M.D., Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE.