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| Name | Class |
|---|---|
| Universidad Nacional Autonoma de Mexico | OTHER |
| National Polytechnic Institute, Mexico | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D | Experimental | 8000 IU of vitamin D orally, once a day, for four weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecalciferol | Drug | Tablets of 4000 IU |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline general T score at 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan M Ocampo GodÃnez, 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE | Mexico City | 07300 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25182228 | Background | Cosman F, de Beur SJ, LeBoff MS, Lewiecki EM, Tanner B, Randall S, Lindsay R; National Osteoporosis Foundation. Clinician's Guide to Prevention and Treatment of Osteoporosis. Osteoporos Int. 2014 Oct;25(10):2359-81. doi: 10.1007/s00198-014-2794-2. Epub 2014 Aug 15. | |
| 12045863 | Background | 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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| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| D006962 | Hyperparathyroidism, Secondary |
| D014808 | Vitamin D Deficiency |
| D049950 | Hyperparathyroidism, Primary |
| D001851 | Bone Diseases, Metabolic |
| D010024 | Osteoporosis |
| D006961 | Hyperparathyroidism |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Not provided
| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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47 participants who met the inclusion criteria were included and all received 8000 IU of vitamin D orally for four weeks.
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| 27801641 | Background | Davis S, Martyn-St James M, Sanderson J, Stevens J, Goka E, Rawdin A, Sadler S, Wong R, Campbell F, Stevenson M, Strong M, Selby P, Gittoes N. A systematic review and economic evaluation of bisphosphonates for the prevention of fragility fractures. Health Technol Assess. 2016 Oct;20(78):1-406. doi: 10.3310/hta20780. |
| 25074351 | Background | Paggiosi MA, Peel N, McCloskey E, Walsh JS, Eastell R. Comparison of the effects of three oral bisphosphonate therapies on the peripheral skeleton in postmenopausal osteoporosis: the TRIO study. Osteoporos Int. 2014 Dec;25(12):2729-41. doi: 10.1007/s00198-014-2817-z. Epub 2014 Jul 30. |
| 26010450 | Background | Chen LX, Zhou ZR, Li YL, Ning GZ, Zhang TS, Zhang D, Feng SQ. Comparison of Bone Mineral Density in Lumbar Spine and Fracture Rate among Eight Drugs in Treatments of Osteoporosis in Men: A Network Meta-Analysis. PLoS One. 2015 May 26;10(5):e0128032. doi: 10.1371/journal.pone.0128032. eCollection 2015. |
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| 9092129 | Background | Lundgren E, Rastad J, Thrufjell E, Akerstrom G, Ljunghall S. Population-based screening for primary hyperparathyroidism with serum calcium and parathyroid hormone values in menopausal women. Surgery. 1997 Mar;121(3):287-94. doi: 10.1016/s0039-6060(97)90357-3. |
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| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |