Frequency of Hyperparathyroidism in Postmenopausal Osteoporosis and Its Treatment

NCT05347082 | Completed DMC

• 1 other identifier: 120.2021
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Postmenopausal Osteoporosis; Postmenopause; Hyperparathyroidism, Secondary; Hypovitaminosis D; Hyperparathyroidism, Primary

Keywords

Vitamin D; Postmenopause; Osteopenia; Osteoporosis; Bone Mineral Density; Hyperparathyroidism

Outcome Measures

Primary Outcomes (4)

• Number of Participants with Remission of Hyperparathyroidism

  Clinical remission of hyperparathyroidism was evaluated after treatment.

  4 weeks

• Number of Participants with Remission of Hypovitaminosis D

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

  4 weeks.

• 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

• 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 Outcomes (1)

• Change from baseline general T score at 4 weeks

  4 weeks

Study Arms (1)

Vitamin D

EXPERIMENTAL

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

Drug: Cholecalciferol

Interventions

Cholecalciferol DRUG

Tablets of 4000 IU

Also known as: Histofil®

Vitamin D

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Regional 1o de Octubre: lead
• Universidad Nacional Autonoma de Mexico: collaborator
• National Polytechnic Institute, Mexico: collaborator

Study Sites (1)

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

Mexico City, 07300, Mexico

Location

Related Publications (23)

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MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Hyperparathyroidism, Secondary; Vitamin D Deficiency; Hyperparathyroidism, Primary; Bone Diseases, Metabolic; Osteoporosis; Hyperparathyroidism

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Parathyroid Diseases; Endocrine System Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• 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.

  STUDY DIRECTOR

• Paula M Sánchez-Tinoco, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: April 17, 2022
• First Posted: April 26, 2022
• Study Start: April 29, 2021
• Primary Completion: December 29, 2021
• Study Completion: February 20, 2022
• Last Updated: May 6, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)