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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daily Teriparatide group | Active Comparator | This group will recieve 20µg of teriparatide by subcutaneous route daily at 8 pm for 1 year |
|
| Weekly Teriparatide group | Experimental | This group will recieve 60µg of teriparatide by subcutaneous route weekly at 8pm on Sunday for 1 year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teriparatide | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| BMD at Hip and lumber spine | DEXA scan(BMD at hip and lumbar spine) at baseline and at the end of 1 year | 1 year |
| Reduction in fracture risk | Reduction in fracture risk using online FRAX tool( WHO fracture risk assessment tool) at baseline and at 1year | 6 week, 6 month and 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sanjay Kr Bhadada, DM | Contact | bhadadask@rediffmail.com | ||
| Vipin Gupta, MBBS | Contact | drvipin.gupta@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Sanjay Kr Bhadada, DM | Associate Professor, Department of Endocrinology, PGIMER Chandigarh India | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PGIMER | Recruiting | Chandigarh | Uttarakhand | 1600012 | India |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D019379 | Teriparatide |
| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |