Efficacy of Denosumab Treatment in Bisphosphonate Unresponsive Patients

NCT ID: NCT04702204

Last Updated: 2021-09-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 73 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2021-08-15

Brief Summary

This study, which was designed as a prospective observational study, was planned to enroll 75 female patients with postmenopausal osteoporosis who had been using bisphosphonates for more than two years and did not respond to treatment. 2 doses of denosumab were administered to the patients every 6 months. Bone mineral density of patients were measured with DEXA at the beginning and end of the study. A total of 66 patients completed the study.

At the end of the study, there was a significant improvement in the femur and lumbar total bone mineral density of the patients compared to the baseline. However, no statistically significant difference was found in terms of the frequency of new fractures.

Conditions

Postmenopausal Osteoporosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Denosumab 60 MG/ML

Denosumab, another antiresorptive agent, is a fully human monoclonal IgG2 antibody that binds to the receptor activator of the nuclear factor-kB ligand (RANKL) with high specificity and affinity. Denosumab inhibits bone resorption by affecting the development, activation, and survival of osteoclasts.

Denosumab 60 mg subcutaneously was administered to the patients whose consent forms were obtained, once every 6 months.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Being a woman with postmenopausal osteoporosis
• Being between the ages of 45-85
• Using bisphosphonate therapy for at least two years
• Vertebral and/or Femur T score below -2.5
• Unresponsive to bisphosphonate therapy

• More than 2% decrease in BMD values despite using bisphosphonates and/or
• New major fracture development during treatment

Exclusion Criteria

• Male gender
• Being extremely thin (BMI <15) or extremely obese (BMI> 45)
• Malignancy
• Severe chronic liver and kidney failure
• Chronic Steroid use
• Having an active rheumatic disease
• Having other secondary causes of osteoporosis (primary hyperparathyroidism etc.).

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Nigde Omer Halisdemir University

OTHER

Sponsor Role: lead

Responsible Party

Ercan KAYDOK

Asst. Prof. MD.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Niğde Bor FTR Education and Training hospital

Niğde, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

13. Miller PD, Pannacciulli N, Malouf-Sierra J, Singer A, Czerwiński E, Bone HG, et al. Efficacy and safety of denosumab vs. bisphosphonates in postmenopausal women previously treated with oral bisphosphonates. Osteoporos Int. 2020;31(1):181-91. 14. Kamimura M, Nakamura Y, Ikegami S, Uchiyama S, Kato H, Taguchi A. Significant improvement of bone mineral density and bone turnover markers by denosumab therapy in bisphosphonate-unresponsive patients. Osteoporos Int. 2017;28(2):559-66. 15. Roux C, Hofbauer LC, Ho PR, Wark JD, Zillikens MC, Fahrleitner-Pammer A, et al. Denosumab compared with risedronate in postmenopausal women suboptimally adherent to alendronate therapy: efficacy and safety results from a randomized open-label study. Bone. 2014;58:48-54 16. von Keyserlingk C, Hopkins R, Anastasilakis A, Toulis K, Goeree R, Tarride JE, et al. Clinical efficacy and safety of denosumab in postmenopausal women with low bone mineral density and osteoporosis: a meta-analysis. Semin Arthritis Rheum. 2011;41(2):178-86.

Reference Type: BACKGROUND

Other Identifiers

123

Identifier Type: -

Identifier Source: org_study_id