Weekly vs Daily Teriparatide Therapy in Severe Postmenopausal Osteoporosis
Status:
Unknown status
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
Osteoporosis is characterized by decreased bone strength and it is prevalent among
postmenopausal women but also occurs in men and women with underlying conditions or major
risk factors associated with bone demineralization. Its chief clinical manifestations are
vertebral and hip fractures, although fractures can occur at any skeletal site.The World
Health Organization (WHO) operationally defines osteoporosis as a bone density that falls 2.5
standard deviations (SD) below the mean for young healthy adults of the same gender-also
referred to as T-score of -2.5. Postmenopausal women who fall at the lower end of the young
normal range (a T-score of >1 SD below the mean) are defined as having low bone density
(osteopenia) and are also at increased risk of osteoporosis. More than 50% of the fractures,
including hip fractures, among postmenopausal women occur in this group.
Teriparatide is one of the most effective treatment options for osteoporosis. But the cost of
teriparatide is prohibitively expensive and in countries like India with limited personal
resources of the individuals, its not a feasible option in the majority of the patients with
severe osteoporosis. The investigators aim to compare weekly versus daily teriparatide
therapy in an open label non inferiority trial and if successful, the investigators
anticipate, the cost of treatment could be reduced considerably so that treatment becomes
more affordable to a larger number of patients. Also with weekly therapy, number of multiple
injections could be brought down.
Phase:
N/A
Details
Lead Sponsor:
Postgraduate Institute of Medical Education and Research