Menopause Clinical Trial
Official title:
Vitamin D Improves Osteoporosis in Postmenopausal Women With Denosumab Failure
NCT number | NCT05372224 |
Other study ID # | 032.2020 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 22, 2020 |
Est. completion date | June 22, 2021 |
Verified date | February 2023 |
Source | Hospital Regional 1o de Octubre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Denosumab is a monoclonal antibody against RANKL ligand, which is used as an alternative treatment for osteoporosis in patients who have a poor response to first-line antiresorptive therapy. However, discontinuation of denosumab produces a rapid increase in bone turnover, bone loss and potentially increased risk of multiple vertebral fractures.
Status | Completed |
Enrollment | 55 |
Est. completion date | June 22, 2021 |
Est. primary completion date | June 22, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 45 Years to 89 Years |
Eligibility | Inclusion Criteria: - Diagnosis of postmenopausal osteoporosis or osteopenia in treatment with denosumab 60mg every six months plus calcium carbonate 1.2g/day + vitamin D 800IU/day. - Diagnosis of hypovitaminosis D, with serum cholecalciferol values <30ng/dL. Exclusion Criteria: - Incomplete clinical records or clinical records. - Age over 90 years. - Diagnosis of secondary (hereditary) osteoporosis. - History of prolonged use of steroids. - Lack of adherence to medical treatment. - Diagnosis of cancer. - Diagnosis of depression. - Diagnosis of Celiac disease or with the presence of alterations in intestinal absorption. - Allergies to any of the medications administered. |
Country | Name | City | State |
---|---|---|---|
Mexico | Patricia Loranca-Moreno | Mexico City | Gustavo A. Madero |
Lead Sponsor | Collaborator |
---|---|
Hospital Regional 1o de Octubre | National Polytechnic Institute, Mexico, Universidad Nacional Autonoma de Mexico |
Mexico,
Cummings SR, San Martin J, McClung MR, Siris ES, Eastell R, Reid IR, Delmas P, Zoog HB, Austin M, Wang A, Kutilek S, Adami S, Zanchetta J, Libanati C, Siddhanti S, Christiansen C; FREEDOM Trial. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med. 2009 Aug 20;361(8):756-65. doi: 10.1056/NEJMoa0809493. Epub 2009 Aug 11. Erratum In: N Engl J Med. 2009 Nov 5;361(19):1914. — View Citation
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. Erratum In: Osteoporos Int. 2020 Jan;31(1):209. Osteoporos Int. 2020 Apr;31(4):801. — View Citation
McClung MR, Wagman RB, Miller PD, Wang A, Lewiecki EM. Observations following discontinuation of long-term denosumab therapy. Osteoporos Int. 2017 May;28(5):1723-1732. doi: 10.1007/s00198-017-3919-1. Epub 2017 Jan 31. — View Citation
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. — View Citation
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. — View Citation
Takeuchi T, Tanaka Y, Soen S, Yamanaka H, Yoneda T, Tanaka S, Nitta T, Okubo N, Genant HK, van der Heijde D. Effects of the anti-RANKL antibody denosumab on joint structural damage in patients with rheumatoid arthritis treated with conventional synthetic disease-modifying antirheumatic drugs (DESIRABLE study): a randomised, double-blind, placebo-controlled phase 3 trial. Ann Rheum Dis. 2019 Jul;78(7):899-907. doi: 10.1136/annrheumdis-2018-214827. Epub 2019 Apr 29. — View Citation
Tsourdi E, Langdahl B, Cohen-Solal M, Aubry-Rozier B, Eriksen EF, Guanabens N, Obermayer-Pietsch B, Ralston SH, Eastell R, Zillikens MC. Discontinuation of Denosumab therapy for osteoporosis: A systematic review and position statement by ECTS. Bone. 2017 Dec;105:11-17. doi: 10.1016/j.bone.2017.08.003. Epub 2017 Aug 5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with hip T-score improvement at 12 months | It refers to the number of participants who improved their hip T-score at three months after treatment. | 12 months | |
Primary | Number of participants with lumbar spine T-score improvement at 12 months | It refers to the number of participants who improved their lumbar spine T-score at three months after treatment. | 12 months | |
Primary | Number of participants with osteoporosis of the hip at 12 months | It refers to the number of participants that present a hip T-score above -2.5 three months after treatment. | 12 months | |
Primary | Number of participants with osteoporosis of the lumbar spine at 12 months | It refers to the number of participants that present a lumbar spine T-score greater than -2.5 three months after treatment. | 12 months | |
Primary | Number of participants with osteopenia on the hip at 12 months | It refers to the number of participants that present a hip T-score from -1 to -2.4 three months after treatment. | 12 months | |
Primary | Number of participants with osteopenia of the lumbar spine at 12 months | It refers to the number of participants that present a lumbar spine T-score from -1 to -2.4 three months after treatment. | 12 months | |
Primary | Number of participants with normal hip T-score at 12 months | It refers to the number of participants that present a hip T-score below -1 three months after treatment. | 12 months | |
Primary | Number of participants with normal lumbar spine T-score at 12 months | It refers to the number of participants that present a lumbar spine T-score below -1 three months after treatment. | 12 months | |
Primary | Number of participants with improvement in serum levels of vitamin D at 12 months | Improvement in serum levels of 25-hydroxy vitamin D [25(OH)D] was considered when serum vitamin D levels increased concerning baseline levels. | 12 months | |
Primary | Number of participants with clinical remission of hypovitaminosis D at 12 months | Remission of hypovitaminosis D was considered when serum levels of 25-hydroxy vitamin D [25(OH)D] were above 29 pg/ml. | 12 months | |
Secondary | Number of participants with vitamin D sufficiency at 12 months | It refers to the number of participants who reached serum levels of vitamin D above 29 pg/ml after three months of treatment. | 12 months | |
Secondary | Number of participants with vitamin D insufficiency at 12 months | It refers to the number of participants who reached serum levels of vitamin D of 21 to 29 pg/ml after three months of treatment. | 12 months | |
Secondary | Number of participants with vitamin D deficiency at 12 months | It refers to the number of participants who reached serum levels of vitamin D less than 20 pg/ml after three months of treatment. | 12 months |
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