Introduction
Current therapies for postmenopausal osteoporosis
Therapy | Efficacy | Safety |
---|---|---|
Active vitamin D | • Transient hypercalcemia [25] | |
Bisphosphonates | ||
Calcium Hormone therapy | • Increased risk of cardiovascular disease [104] | |
ET | • Reduces bone loss and fracture risk [49] | • Increased risk of stroke and VTEs [51] |
EPT | • Reduces bone loss and fracture risk [48] | • Increased risk of stroke, VTEs, and breast cancer [52] |
Calcitonin | • Nausea, vomiting, dizziness, leg cramps, hot flushes, and inflammation/irritation at administration site [107] | |
PTH | ||
Denosumab | • Reduces vertebral, nonvertebral, and hip fracture risk [67] | • Atypical fractures, delayed fracture healing, and ONJ [68] |
SERMs | ||
RLX | ||
LAS | • Reduces vertebral and nonvertebral fracture risk [75] | • Increased incidences of hot flushes and leg cramps [75] • Increased rates of AEs related to the reproductive tract and number of diagnostic uterine procedures [76] |
BZA |
Calcium supplementation and vitamin D
Bisphosphonates
Hormone therapy
Calcitonin
PTH
Denosumab
SERMs
SERMs for postmenopausal osteoporosis
RLX
LAS
BZA
Preclinical studies of BZA
Clinical studies of BZA
Parameter | Global prevention study (N = 1,583) | Global treatment study (N = 7,492) | Japanese phase 2 study (N = 429) |
---|---|---|---|
Overall safety/tolerability | • Similar AE rates compared with placebo [85] | • Similar AE rates among groups [94] | |
Cardiac events | • No cardiac safety concerns [85] | • Incidence was low and similar among groups [94] | |
Cerebrovascular events | • Incidence was low and similar among groups [85] | • Incidence was low and similar among groups [94] | |
VTEs | • Incidence was low and similar among groups [85] | • No cases reported [94] | |
Endometrial safety | • No differences among groups in change in endometrial thickness [86] • No confirmed cases of endometrial carcinoma or hyperplasia [86] | • No differences among groups in change in endometrial thickness [94] • No cases of endometrial carcinoma or hyperplasia reported [94] | |
Breast safety | • Incidence of breast-related AEs was low and similar among groups [86] | • Incidence of breast-related AEs was low and similar among groups [94] | |
Other reproductive safety | • No other reproductive safety concerns [86] | • No other reproductive safety concerns [94] |