Frequency of Hyperparathyroidism in Postmenopausal Osteoporosis and Its Treatment

April 30, 2022 updated by: Hospital Regional 1o de Octubre

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico, 07300
        • Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Remission of Hyperparathyroidism
Time Frame: 4 weeks
Clinical remission of hyperparathyroidism was evaluated after treatment.
4 weeks
Number of Participants with Remission of Hypovitaminosis D
Time Frame: 4 weeks.
Clinical remission of vitamin D deficiency or insufficiency were evaluated after treatment.
4 weeks.
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 weeks
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.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Regional 1o de Octubre

Collaborators

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.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2021

Primary Completion (Actual)

December 29, 2021

Study Completion (Actual)

February 20, 2022

Study Registration Dates

First Submitted

April 17, 2022

First Submitted That Met QC Criteria

April 20, 2022

First Posted (Actual)

April 26, 2022

Study Record Updates

Last Update Posted (Actual)

May 6, 2022

Last Update Submitted That Met QC Criteria

April 30, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 120.2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hyperparathyroidism, Primary

Clinical Trials on Cholecalciferol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe