Efficacy of Denosumab Treatment in Bisphosphonate Unresponsive Patients

Nigde Omer Halisdemir University

Status: Completed

Conditions: Postmenopausal Osteoporosis

Treatments: Drug: Denosumab 60 MG/ML

Study type: Observational

Funder types: Other

Identifiers

NCT04702204

123

Details and patient eligibility

About

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.

Enrollment: 73 patients

Sex: Female

Ages: 45 to 85 years old

Volunteers: No 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.).