Efficacy of Denosumab Treatment in Bisphosphonate Unresponsive Patients

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.

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Key information

Conditions

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

Age range

45 year–85 year

Sex eligibility

Female

Study type

Observational

Primary location

Niğde Bor FTR Education and Training hospital

Niğde, 51000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

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.

Primary outcomes

Bone mineral density

Time frame: 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 outcomes

Major Bone Fracture

Time frame: 12 month

number of newly developed vertebral and femur fractures during follow-up

Sponsors and collaborators

Lead sponsor

Nigde Omer Halisdemir University

Other

Registry information

Official study title

Efficacy and Safety of Denosumab Treatment in Bisphosphonate Unresponsive Postmenopausal Osteoporotic

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Jan 8, 2021
Registry last updated: Sep 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed