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Frequency of Hyperparathyroidism in Postmenopausal Osteoporosis and Its Treatment

Primary Purpose

Postmenopausal Osteoporosis, Postmenopause, Hyperparathyroidism, Secondary

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Cholecalciferol
Sponsored by
Hospital Regional 1o de Octubre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postmenopausal Osteoporosis focused on measuring Vitamin D, Postmenopause, Osteopenia, Osteoporosis, Bone Mineral Density, Hyperparathyroidism

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vitamin D

Arm Description

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

Outcomes

Primary Outcome Measures

Number of Participants with Remission of Hyperparathyroidism
Clinical remission of hyperparathyroidism was evaluated after treatment.
Number of Participants with Remission of Hypovitaminosis D
Clinical remission of vitamin D deficiency or insufficiency were evaluated after treatment.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 17, 2022
Last Updated
April 30, 2022
Sponsor
Hospital Regional 1o de Octubre
Collaborators
Universidad Nacional Autonoma de Mexico, National Polytechnic Institute, Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT05347082
Brief Title
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
April 29, 2021 (Actual)
Primary Completion Date
December 29, 2021 (Actual)
Study Completion Date
February 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Regional 1o de Octubre
Collaborators
Universidad Nacional Autonoma de Mexico, National Polytechnic Institute, Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Osteoporosis, Postmenopause, Hyperparathyroidism, Secondary, Hypovitaminosis D, Hyperparathyroidism, Primary
Keywords
Vitamin D, Postmenopause, Osteopenia, Osteoporosis, Bone Mineral Density, Hyperparathyroidism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
47 participants who met the inclusion criteria were included and all received 8000 IU of vitamin D orally for four weeks.
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D
Arm Type
Experimental
Arm Description
8000 IU of vitamin D orally, once a day, for four weeks.
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Other Intervention Name(s)
Histofil®
Intervention Description
Tablets of 4000 IU
Primary Outcome Measure Information:
Title
Number of Participants with Remission of Hyperparathyroidism
Description
Clinical remission of hyperparathyroidism was evaluated after treatment.
Time Frame
4 weeks
Title
Number of Participants with Remission of Hypovitaminosis D
Description
Clinical remission of vitamin D deficiency or insufficiency were evaluated after treatment.
Time Frame
4 weeks.
Title
Change from baseline hip T score at 4 weeks
Description
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.
Time Frame
4 weeks
Title
Change from baseline lumbar spine T score at 4 weeks
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change from baseline general T score at 4 weeks
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan M Ocampo Godínez, M.D., Ph.D.
Organizational Affiliation
Tissue Bioengineering Laboratory, National Autonomous University of Mexico [UNAM]
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Patricia Loranca-Moreno, M.D., M.Sc.
Organizational Affiliation
Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Paula M Sánchez-Tinoco, M.D.
Organizational Affiliation
Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE
City
Mexico City
ZIP/Postal Code
07300
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25182228
Citation
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. Erratum In: Osteoporos Int. 2015 Jul;26(7):2045-7.
Results Reference
background
PubMed Identifier
12045863
Citation
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.
Results Reference
background
PubMed Identifier
15644400
Citation
Grey A, Lucas J, Horne A, Gamble G, Davidson JS, Reid IR. Vitamin D repletion in patients with primary hyperparathyroidism and coexistent vitamin D insufficiency. J Clin Endocrinol Metab. 2005 Apr;90(4):2122-6. doi: 10.1210/jc.2004-1772. Epub 2005 Jan 11.
Results Reference
background
PubMed Identifier
19383807
Citation
Tucci JR. Vitamin D therapy in patients with primary hyperparathyroidism and hypovitaminosis D. Eur J Endocrinol. 2009 Jul;161(1):189-93. doi: 10.1530/EJE-08-0901. Epub 2009 Apr 21.
Results Reference
background
PubMed Identifier
29267648
Citation
Contreras-Manzano A, Villalpando S, Robledo-Perez R. Vitamin D status by sociodemographic factors and body mass index in Mexican women at reproductive age. Salud Publica Mex. 2017 Sep-Oct;59(5):518-525. doi: 10.21149/8080.
Results Reference
background
PubMed Identifier
29435763
Citation
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.
Results Reference
background
PubMed Identifier
21872800
Citation
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.
Results Reference
background
PubMed Identifier
11493580
Citation
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.
Results Reference
background
PubMed Identifier
17182297
Citation
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.
Results Reference
background
PubMed Identifier
12904517
Citation
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.
Results Reference
background
PubMed Identifier
17598097
Citation
Watson J, Wise L, Green J. Prescribing of hormone therapy for menopause, tibolone, and bisphosphonates in women in the UK between 1991 and 2005. Eur J Clin Pharmacol. 2007 Sep;63(9):843-9. doi: 10.1007/s00228-007-0320-6. Epub 2007 Jun 28.
Results Reference
background
PubMed Identifier
27801641
Citation
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. Erratum In: Health Technol Assess. 2018 Mar;20(78):407-424.
Results Reference
background
PubMed Identifier
25074351
Citation
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.
Results Reference
background
PubMed Identifier
26010450
Citation
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.
Results Reference
background
PubMed Identifier
30890377
Citation
Yuan F, Peng W, Yang C, Zheng J. Teriparatide versus bisphosphonates for treatment of postmenopausal osteoporosis: A meta-analysis. Int J Surg. 2019 Jun;66:1-11. doi: 10.1016/j.ijsu.2019.03.004. Epub 2019 Mar 16.
Results Reference
background
PubMed Identifier
30508820
Citation
Chang B, Quan Q, Li Y, Qiu H, Peng J, Gu Y. Treatment of Osteoporosis, with a Focus on 2 Monoclonal Antibodies. Med Sci Monit. 2018 Dec 3;24:8758-8766. doi: 10.12659/MSM.912309.
Results Reference
background
PubMed Identifier
26144908
Citation
Leder BZ, Tsai JN, Uihlein AV, Wallace PM, Lee H, Neer RM, Burnett-Bowie SA. Denosumab and teriparatide transitions in postmenopausal osteoporosis (the DATA-Switch study): extension of a randomised controlled trial. Lancet. 2015 Sep 19;386(9999):1147-55. doi: 10.1016/S0140-6736(15)61120-5. Epub 2015 Jul 2.
Results Reference
background
PubMed Identifier
9092129
Citation
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.
Results Reference
background
PubMed Identifier
34647149
Citation
Wihlborg A, Bergstrom K, Gerdhem P, Bergstrom I. Parathyroid Hormone Disturbances in Postmenopausal Women with Distal Forearm Fracture. World J Surg. 2022 Jan;46(1):128-135. doi: 10.1007/s00268-021-06331-w. Epub 2021 Oct 13.
Results Reference
background
PubMed Identifier
22677209
Citation
Souberbielle JC, Bienaime F, Cavalier E, Cormier C. Vitamin D and primary hyperparathyroidism (PHPT). Ann Endocrinol (Paris). 2012 Jun;73(3):165-9. doi: 10.1016/j.ando.2012.04.008. Epub 2012 Jun 5.
Results Reference
background
PubMed Identifier
24423366
Citation
Rolighed L, Rejnmark L, Sikjaer T, Heickendorff L, Vestergaard P, Mosekilde L, Christiansen P. Vitamin D treatment in primary hyperparathyroidism: a randomized placebo controlled trial. J Clin Endocrinol Metab. 2014 Mar;99(3):1072-80. doi: 10.1210/jc.2013-3978. Epub 2014 Jan 13.
Results Reference
background
PubMed Identifier
15797954
Citation
Holick MF, Siris ES, Binkley N, Beard MK, Khan A, Katzer JT, Petruschke RA, Chen E, de Papp AE. Prevalence of Vitamin D inadequacy among postmenopausal North American women receiving osteoporosis therapy. J Clin Endocrinol Metab. 2005 Jun;90(6):3215-24. doi: 10.1210/jc.2004-2364. Epub 2005 Mar 29.
Results Reference
background
PubMed Identifier
17462085
Citation
Neuprez A, Bruyere O, Collette J, Reginster JY. Vitamin D inadequacy in Belgian postmenopausal osteoporotic women. BMC Public Health. 2007 Apr 26;7:64. doi: 10.1186/1471-2458-7-64.
Results Reference
background

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Frequency of Hyperparathyroidism in Postmenopausal Osteoporosis and Its Treatment

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