Efficacy of Denosumab Treatment in Bisphosphonate Unresponsive Patients

NCT04702204 | Completed

• 1 other identifier: 123
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Bone mineral density

  Femur and spine bone mineral density measurements of the patients at the baseline and the 12th month were performed using the Dual Energy X-ray Absorptiometry (DEXA) machine (Stratos dR 2D Fan-Beam, DMS company, France).

  12 month

Secondary Outcomes (1)

• Major Bone Fracture

  12 month

Interventions

Denosumab 60 MG/ML DRUG

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.

Eligibility Criteria

• Age: 45 Years - 85 Years
• Gender Eligibility Details: Because denosumab treatment only has FDA approval for postmenopausal osteoporosis.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Nigde Omer Halisdemir University: lead

Study Sites (1)

Niğde Bor FTR Education and Training hospital

Niğde, 51000, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Denosumab

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof. MD.

Study Record Dates

• First Submitted: January 3, 2021
• First Posted: January 8, 2021
• Study Start: July 1, 2020
• Primary Completion: August 15, 2021
• Study Completion: August 15, 2021
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)