Osteopenia
Conditions
Interventions
oral monthly minodronate, 50 mg once monthly, use for 1year
subcutaneous injection of denosumab, 60 mg every 6 months use for 1 year
observation (contorol) for 1 year
Sponsors
Department of Urology and Andrology, Kansai Medical University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1)ECOG performance status 0-1 2)Androgen deprivation therapy planned more than next one year 3) Androgen deprivation therapy<1 yr ,or Androgen deprivation therapy>1 yr and Young Adult Mean<90%
Exclusion criteria
Exclusion criteria: 1)Bone metastasis 2)Castration resistance prostate cancer 3)hypocalcaemia Ca<8mg/dl 4)Androgen deprivation therapy>1 yr and Young Adult Mean>90% 5)Prior treatment with a bisphosphonate, RANKL, parathyroid hormone 6)Prior treatment with a glucocorticoids 7)Under treatment of tooth 8)A history of achalasia 9)Estimated glomerular filtration rate <35 ml/min 10)Liver function tests>1.5 times the upper limit of normal 11)Bilateral hip replacement 12)A history of metabolic bone disease (Paget disease, hyperparathyroidism, osteomalacia, untreated hypothyroidism) 13) The patients should be excluded ,Who have poor medical compliance, drug-induced allergy, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage change in spine BMD | — |
Secondary
| Measure | Time frame |
|---|---|
| The percentage change in total hip and femoral neck The percentage changes in bone markers of resorption and formation The incidence of skeletal-related event The incidence of adverse events in minodronate and denosumab treatment The Adherence of minodronate and denosumab The efficacy of each drug(the percentage change in BMD, The percentage changes in bone markers ) | — |
Countries
Japan
Contacts
Public ContactTakashi Yoshida
Kansai Medical University Department of Urology and Andrology
Outcome results
None listed