Clinical trial NCT04702204: Efficacy of Denosumab Treatment in Bisphosphonate Unresponsive Patients
Official title: Efficacy and Safety of Denosumab Treatment in Bisphosphonate Unresponsive Postmenopausal Osteoporotic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postmenopausal Osteoporosis
Lead sponsor: Nigde Omer Halisdemir University
Sponsor class: OTHER
First posted: 2021-01-08
Enrollment: 73
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.).

Primary outcomes:
measure: Bone mineral density
timeFrame: 12 month
Secondary outcomes:
measure: Major Bone Fracture
timeFrame: 12 month
Other outcomes:
Locations:
city: Niğde
country: Turkey
facility: Niğde Bor FTR Education and Training hospital
Study officials:
References:
citation: 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.