Efficacy of Denosumab Treatment in Bisphosphonate Unresponsive Patients

Sponsor

Nigde Omer Halisdemir University (Other)

Overall Status

Completed

CT.gov ID

NCT04702204

Collaborator

(none)

Enrollment

Location

13.5

Actual Duration (Months)

5.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postmenopausal Osteoporosis	Drug: Denosumab 60 MG/ML

Study Design

Study Type:

Observational

Actual Enrollment :

73 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Efficacy and Safety of Denosumab Treatment in Bisphosphonate Unresponsive Postmenopausal Osteoporotic

Actual Study Start Date :

Jul 1, 2020

Actual Primary Completion Date :

Aug 15, 2021

Actual Study Completion Date :

Aug 15, 2021

Outcome Measures

Primary Outcome Measures

Bone mineral density [12 month]
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).

Secondary Outcome Measures

Major Bone Fracture [12 month]
number of newly developed vertebral and femur fractures during follow-up

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 85 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Niğde Bor FTR Education and Training hospital	Niğde		Turkey	51000

Sponsors and Collaborators

Nigde Omer Halisdemir University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Ercan KAYDOK, Asst. Prof. MD., Nigde Omer Halisdemir University

ClinicalTrials.gov Identifier:

NCT04702204

Other Study ID Numbers:

First Posted:

Jan 8, 2021

Last Update Posted:

Sep 1, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Osteoporosis

Osteoporosis, Postmenopausal

Denosumab

Study Results

No Results Posted as of Sep 1, 2021