drugset / Trial / NCT05346419
Antiresorptive Effect of Treatment With Risedronate and Vitamin D in Postmenopausal Patients
Completed
33 enrolled
Hospital Regional 1o de Octubre
National Polytechnic Institute, Mexico · collabUniversidad Nacional Autonoma de Mexico · collab
NaSingle-groupOpen-labelTreatment
Summary
Osteoporosis is defined as a systemic disease of bone mineralization, characterized by a decrease in bone mineral density that causes bone fragility and increases the risk of fractures during menopause. Recently, a high prevalence of hypovitaminosis D has been found worldwide, which could trigger a state of secondary hyperparathyroidism that can worsen the state of postmenopausal patients with osteoporosis. An open-label, clinical trial was conducted in Mexican women with postmenopausal osteopenia-osteoporosis to determine the efficacy of the combined treatment with risedronate and high-dose vitamin D in improving bone mineral density, hyperparathyroidism, and hypovitaminosis D.
Timeline
- Start
- 2021-07-01
- Primary completion
- 2022-02-03
- Completion
- 2022-02-26
Publications
- Background Cossio-Bolanos M, Vidal-Espinoza R, Fuentes-Lopez J, Castelli Correia de Campos LF, Andruske CL, Urra-Albornoz C, Alvear Vasquez F, Gomez-Campos R. Reference values for bone density and bone mineral content from 5 to 80 years old in a province of Chile. PeerJ. 2022 Mar 23;10:e13092. doi: 10.7717/peerj.13092. eCollection 2022.
- Background Kanis JA, Cooper C, Rizzoli R, Reginster JY; Scientific Advisory Board of the European Society for Clinical and Economic Aspects of Osteoporosis (ESCEO) and the Committees of Scientific Advisors and National Societies of the International Osteoporosis Foundation (IOF). European guidance for the diagnosis and management of osteoporosis in postmenopausal women. Osteoporos Int. 2019 Jan;30(1):3-44. doi: 10.1007/s00198-018-4704-5. Epub 2018 Oct 15.
- Background Deng W, Han JC, Chen L, Qi WL. Estrogen receptor alpha gene PvuII polymorphism and risk of fracture in postmenopausal women: a meta-analysis. Genet Mol Res. 2015 Feb 13;14(1):1293-300. doi: 10.4238/2015.February.13.8.
- Background Aziziyeh R, Amin M, Habib M, Perlaza JG, McTavish RK, Ludke A, Fernandes S, Sripada K, Cameron C. A scorecard for osteoporosis in four Latin American countries: Brazil, Mexico, Colombia, and Argentina. Arch Osteoporos. 2019 Jun 27;14(1):69. doi: 10.1007/s11657-019-0622-1.
- Background Moschonis G, van den Heuvel EG, Mavrogianni C, Manios Y. Effect of Vitamin D-Enriched Gouda-Type Cheese Consumption on Biochemical Markers of Bone Metabolism in Postmenopausal Women in Greece. Nutrients. 2021 Aug 27;13(9):2985. doi: 10.3390/nu13092985.
- Background Bouloukaki I, Markakis M, Pateli R, Lyronis I, Schiza S, Tsiligianni I. Vitamin D levels in primary care patients: correlations with clinical, seasonal, and quality-of-life parameters. Fam Pract. 2022 Jul 19;39(4):678-684. doi: 10.1093/fampra/cmac012.
- Background Dixit V, Tripathi RL, Dhanwal DK. Lack of secondary hyperparathyroidism in sub-group of vitamin D deficient postmenopausal women: Is VDR gene polymorphism behind this mystery? Diabetes Metab Syndr. 2022 Jan;16(1):102381. doi: 10.1016/j.dsx.2021.102381. Epub 2021 Dec 28.
- Background Lips P, Hosking D, Lippuner K, Norquist JM, Wehren L, Maalouf G, Ragi-Eis S, Chandler J. The prevalence of vitamin D inadequacy amongst women with osteoporosis: an international epidemiological investigation. J Intern Med. 2006 Sep;260(3):245-54. doi: 10.1111/j.1365-2796.2006.01685.x.
- Background Martinez-Zavala N, Lopez-Sanchez GN, Vergara-Lopez A, Chavez-Tapia NC, Uribe M, Nuno-Lambarri N. Vitamin D deficiency in Mexicans have a high prevalence: a cross-sectional analysis of the patients from the Centro Medico Nacional 20 de Noviembre. Arch Osteoporos. 2020 Jun 16;15(1):88. doi: 10.1007/s11657-020-00765-w.
- Background 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.
- Background Yalla N, Bobba G, Guo G, Stankiewicz A, Ostlund R. Parathyroid hormone reference ranges in healthy individuals classified by vitamin D status. J Endocrinol Invest. 2019 Nov;42(11):1353-1360. doi: 10.1007/s40618-019-01075-w. Epub 2019 Jul 4.
- Background Clark P, Vivanco-Munoz N, Pina JT, Rivas-Ruiz R, Huitron G, Chico-Barba G, Reza-Albarran AA. High prevalence of hypovitaminosis D in Mexicans aged 14 years and older and its correlation with parathyroid hormone. Arch Osteoporos. 2015;10:225. doi: 10.1007/s11657-015-0225-4. Epub 2015 Jul 14.
- Background 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.
- Background Miller PD, Hattersley G, Riis BJ, Williams GC, Lau E, Russo LA, Alexandersen P, Zerbini CA, Hu MY, Harris AG, Fitzpatrick LA, Cosman F, Christiansen C; ACTIVE Study Investigators. Effect of Abaloparatide vs Placebo on New Vertebral Fractures in Postmenopausal Women With Osteoporosis: A Randomized Clinical Trial. JAMA. 2016 Aug 16;316(7):722-33. doi: 10.1001/jama.2016.11136.
- Background Soreskog E, Lindberg I, Kanis JA, Akesson KE, Willems D, Lorentzon M, Strom O, Berling P, Borgstrom F. Cost-effectiveness of romosozumab for the treatment of postmenopausal women with severe osteoporosis at high risk of fracture in Sweden. Osteoporos Int. 2021 Mar;32(3):585-594. doi: 10.1007/s00198-020-05780-8. Epub 2021 Jan 6.
- Background Miyoshi A, Kameda H, Nagai S, Nakamura A, Miya A, Takase T, Atsumi T, Miyoshi H. Beneficial effects of switching to denosumab from bisphosphonates or selective estrogen receptor modulators in postmenopausal women with type 2 diabetes and osteopenia/osteoporosis. J Diabetes Investig. 2021 Jul;12(7):1293-1300. doi: 10.1111/jdi.13458. Epub 2020 Dec 13.
- Background Eastell R, Rosen CJ, Black DM, Cheung AM, Murad MH, Shoback D. Pharmacological Management of Osteoporosis in Postmenopausal Women: An Endocrine Society* Clinical Practice Guideline. J Clin Endocrinol Metab. 2019 May 1;104(5):1595-1622. doi: 10.1210/jc.2019-00221.
- Background Kobayakawa T, Miyazaki A, Saito M, Suzuki T, Takahashi J, Nakamura Y. Denosumab versus romosozumab for postmenopausal osteoporosis treatment. Sci Rep. 2021 Jun 3;11(1):11801. doi: 10.1038/s41598-021-91248-6.
- Background Hiligsmann M, Reginster JY. Cost-effectiveness of gastro-resistant risedronate tablets for the treatment of postmenopausal women with osteoporosis in France. Osteoporos Int. 2019 Mar;30(3):649-658. doi: 10.1007/s00198-018-04821-7. Epub 2019 Jan 30.
- Background McClung MR, Ebetino FH. History of risedronate. Bone. 2020 Aug;137:115407. doi: 10.1016/j.bone.2020.115407. Epub 2020 May 6.
- Background American Geriatrics Society Workgroup on Vitamin D Supplementation for Older Adults. Recommendations abstracted from the American Geriatrics Society Consensus Statement on vitamin D for Prevention of Falls and Their Consequences. J Am Geriatr Soc. 2014 Jan;62(1):147-52. doi: 10.1111/jgs.12631. Epub 2013 Dec 18.
- Background Jilka RL, Weinstein RS, Bellido T, Roberson P, Parfitt AM, Manolagas SC. Increased bone formation by prevention of osteoblast apoptosis with parathyroid hormone. J Clin Invest. 1999 Aug;104(4):439-46. doi: 10.1172/JCI6610.
- Background Balani DH, Ono N, Kronenberg HM. Parathyroid hormone regulates fates of murine osteoblast precursors in vivo. J Clin Invest. 2017 Sep 1;127(9):3327-3338. doi: 10.1172/JCI91699. Epub 2017 Jul 31.
- Background Brent MB, Stoltenborg FE, Bruel A, Thomsen JS. Teriparatide and Abaloparatide Have a Similar Effect on Bone in Mice. Front Endocrinol (Lausanne). 2021 Apr 19;12:628994. doi: 10.3389/fendo.2021.628994. eCollection 2021.
- Background McClung MR, Harvey NC, Fitzpatrick LA, Miller PD, Hattersley G, Wang Y, Cosman F. Effects of abaloparatide on bone mineral density and risk of fracture in postmenopausal women aged 80 years or older with osteoporosis. Menopause. 2018 Jul;25(7):767-771. doi: 10.1097/GME.0000000000001080.
- Background Neer RM, Arnaud CD, Zanchetta JR, Prince R, Gaich GA, Reginster JY, Hodsman AB, Eriksen EF, Ish-Shalom S, Genant HK, Wang O, Mitlak BH. Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med. 2001 May 10;344(19):1434-41. doi: 10.1056/NEJM200105103441904.
- Background Haas AV, LeBoff MS. Osteoanabolic Agents for Osteoporosis. J Endocr Soc. 2018 Jul 9;2(8):922-932. doi: 10.1210/js.2018-00118. eCollection 2018 Aug 1.
- Background Lindsay R, Nieves J, Formica C, Henneman E, Woelfert L, Shen V, Dempster D, Cosman F. Randomised controlled study of effect of parathyroid hormone on vertebral-bone mass and fracture incidence among postmenopausal women on oestrogen with osteoporosis. Lancet. 1997 Aug 23;350(9077):550-5. doi: 10.1016/S0140-6736(97)02342-8.
- Background Choi H, Magyar CE, Nervina JM, Tetradis S. Different duration of parathyroid hormone exposure distinctively regulates primary response genes Nurr1 and RANKL in osteoblasts. PLoS One. 2018 Dec 21;13(12):e0208514. doi: 10.1371/journal.pone.0208514. eCollection 2018.
- Background Choudhary S, Santone E, Yee SP, Lorenzo J, Adams DJ, Goetjen A, McCarthy MB, Mazzocca AD, Pilbeam C. Continuous PTH in Male Mice Causes Bone Loss Because It Induces Serum Amyloid A. Endocrinology. 2018 Jul 1;159(7):2759-2776. doi: 10.1210/en.2018-00265.
- Background Saag KG, Petersen J, Brandi ML, Karaplis AC, Lorentzon M, Thomas T, Maddox J, Fan M, Meisner PD, Grauer A. Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis. N Engl J Med. 2017 Oct 12;377(15):1417-1427. doi: 10.1056/NEJMoa1708322. Epub 2017 Sep 11.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Risedronate | Small molecule | 35 mg | — |
| Subject | Vitamin D | Other / unclassified | 2800 iu | — |
| Subject | Vitamin D | Other / unclassified | 4000 iu | — |