Frequency of Hyperparathyroidism in Postmenopausal Osteoporosis and Its Treatment
NCT ID: NCT05347082
Last Updated: 2022-05-06
Study Results
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Basic Information
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COMPLETED
NA
47 participants
INTERVENTIONAL
2021-04-29
2022-02-20
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Vitamin D
8000 IU of vitamin D orally, once a day, for four weeks.
Cholecalciferol
Tablets of 4000 IU
Interventions
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Cholecalciferol
Tablets of 4000 IU
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Postmenopausal osteoporosis or osteopenia.
* Primary or secondary hyperparathyroidism.
* Insufficiency or deficiency of vitamin D.
* Multi-treated postmenopausal osteoporosis.
* Postmenopausal osteoporosis without treatment.
Exclusion Criteria
* 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.
FEMALE
No
Sponsors
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Universidad Nacional Autonoma de Mexico
OTHER
National Polytechnic Institute, Mexico
OTHER
Hospital Regional 1o de Octubre
OTHER
Responsible Party
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Principal Investigators
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Juan M Ocampo Godínez, M.D., Ph.D.
Role: STUDY_DIRECTOR
Tissue Bioengineering Laboratory, National Autonomous University of Mexico [UNAM]
Patricia Loranca-Moreno, M.D., M.Sc.
Role: STUDY_DIRECTOR
Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE.
Paula M Sánchez-Tinoco, M.D.
Role: PRINCIPAL_INVESTIGATOR
Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE.
Locations
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Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE
Mexico City, , Mexico
Countries
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References
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Goltzman D. Functions of vitamin D in bone. Histochem Cell Biol. 2018 Apr;149(4):305-312. doi: 10.1007/s00418-018-1648-y. Epub 2018 Feb 12.
Lips P, van Schoor NM. The effect of vitamin D on bone and osteoporosis. Best Pract Res Clin Endocrinol Metab. 2011 Aug;25(4):585-91. doi: 10.1016/j.beem.2011.05.002.
Lips P. Vitamin D deficiency and secondary hyperparathyroidism in the elderly: consequences for bone loss and fractures and therapeutic implications. Endocr Rev. 2001 Aug;22(4):477-501. doi: 10.1210/edrv.22.4.0437.
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Recker RR, Kendler D, Recknor CP, Rooney TW, Lewiecki EM, Utian WH, Cauley JA, Lorraine J, Qu Y, Kulkarni PM, Gaich CL, Wong M, Plouffe L Jr, Stock JL. Comparative effects of raloxifene and alendronate on fracture outcomes in postmenopausal women with low bone mass. Bone. 2007 Apr;40(4):843-51. doi: 10.1016/j.bone.2006.11.001. Epub 2006 Dec 19.
Manson JE, Hsia J, Johnson KC, Rossouw JE, Assaf AR, Lasser NL, Trevisan M, Black HR, Heckbert SR, Detrano R, Strickland OL, Wong ND, Crouse JR, Stein E, Cushman M; Women's Health Initiative Investigators. Estrogen plus progestin and the risk of coronary heart disease. N Engl J Med. 2003 Aug 7;349(6):523-34. doi: 10.1056/NEJMoa030808.
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Lundgren E, Hagstrom EG, Lundin J, Winnerback K, Roos J, Ljunghall S, Rastad J. Primary hyperparathyroidism revisited in menopausal women with serum calcium in the upper normal range at population-based screening 8 years ago. World J Surg. 2002 Aug;26(8):931-6. doi: 10.1007/s00268-002-6621-0. Epub 2002 Jun 6.
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Other Identifiers
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120.2021
Identifier Type: -
Identifier Source: org_study_id
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