Clinical trial NCT05347082: Frequency of Hyperparathyroidism in Postmenopausal Osteoporosis and Its Treatment
Official title: Resolution of Hyperparathyroidism With High-dose Vitamin D Improves Osteoporosis in Multi-treated Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postmenopausal Osteoporosis
Postmenopause
Hyperparathyroidism, Secondary
Hypovitaminosis D
Hyperparathyroidism, Primary
Keywords: Vitamin D
Postmenopause
Osteopenia
Osteoporosis
Bone Mineral Density
Hyperparathyroidism
Lead sponsor: Hospital Regional 1o de Octubre
Sponsor class: OTHER
Collaborators: name: Universidad Nacional Autonoma de Mexico
name: National Polytechnic Institute, Mexico
First posted: 2022-04-26
Enrollment: 47
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 47 participants who met the inclusion criteria were included and all received 8000 IU of vitamin D orally for four weeks.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants with Remission of Hyperparathyroidism
timeFrame: 4 weeks
measure: Number of Participants with Remission of Hypovitaminosis D
timeFrame: 4 weeks.
measure: Change from baseline hip T score at 4 weeks
timeFrame: 4 weeks
measure: Change from baseline lumbar spine T score at 4 weeks
timeFrame: 4 weeks
Secondary outcomes:
measure: Change from baseline general T score at 4 weeks
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE
Study officials:
affiliation: Tissue Bioengineering Laboratory, National Autonomous University of Mexico [UNAM]
name: Juan M Ocampo Godínez, M.D., Ph.D.
role: STUDY_DIRECTOR
affiliation: Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE.
name: Patricia Loranca-Moreno, M.D., M.Sc.
role: STUDY_DIRECTOR
affiliation: Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE.
name: Paula M Sánchez-Tinoco, M.D.
role: PRINCIPAL_INVESTIGATOR
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