Effect of Vitamin D and Denosumab on Bone Remodelling in Women With Postmenopausal Osteoporosis

NCT05372224 | Completed DMC

• 1 other identifier: 032.2020
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypovitaminosis D; Osteoporosis, Postmenopausal; Menopause

Keywords

Vitamin D; Postmenopausal Osteoporosis; Denosumab; Hypovitaminosis D; Osteoporosis; Osteopenia

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (3)

• Number of participants with vitamin D sufficiency at 12 months

  12 months

• Number of participants with vitamin D insufficiency at 12 months

  12 months

• Number of participants with vitamin D deficiency at 12 months

  12 months

Study Arms (1)

Vitamin D 4000 IU

EXPERIMENTAL

4000 IU of vitamin D were administrated once a day orally and calcium carbonate 1.2 g a day in a single dose.

Drug: Cholecalciferol

Interventions

Cholecalciferol DRUG

4000 IU were administrated once a day for 3 months.

Also known as: Histofil®

Vitamin D 4000 IU

Eligibility Criteria

• Age: 45 Years - 89 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Regional 1o de Octubre: lead
• Universidad Nacional Autonoma de Mexico: collaborator
• National Polytechnic Institute, Mexico: collaborator

Study Sites (1)

Patricia Loranca-Moreno

Mexico City, Gustavo A. Madero, 07300, Mexico

Location

Related Publications (7)

• 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.

  PMID: 28789921 BACKGROUND

• 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.

  PMID: 28144701 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.

  PMID: 30324412 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.

  PMID: 33141482 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.

  PMID: 28892457 BACKGROUND

• 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.

  PMID: 19671655 BACKGROUND

• 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.

  PMID: 31036625 BACKGROUND

MeSH Terms

Conditions

Vitamin D Deficiency; Osteoporosis, Postmenopausal; Osteoporosis; Bone Diseases, Metabolic

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• María B Brito-Gavilanes, M.D.

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

  PRINCIPAL INVESTIGATOR

• Patricia Loranca-Moreno, M.D., M.Sc.

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

  PRINCIPAL INVESTIGATOR

• Juan M Ocampo-Godínez, M.D., P.hD

  Laboratory of Tissue Engineering, UNAM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 76 participants were considered from the climacteric clinic of the regional hospital "1o de Octubre" of the Institute of Security and Social Services for State Workers (ISSSTE), of which 23 presented elimination criteria, and 55 were included in the study.

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 12, 2022
• Study Start: June 22, 2020
• Primary Completion: June 22, 2021
• Study Completion: June 22, 2021
• Last Updated: February 17, 2023

Record last verified: 2023-02

Locations

ME (1)