Weekly vs Daily Teriparatide Therapy in Severe Postmenopausal Osteoporosis

Study Overview
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Brief Summary
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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.

Official Title
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To Compare Efficacy of Weekly Versus Daily Teriparatide in the Management of Postmenopausal Osteoporosis

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: Teriparatide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postmenopausal women of age group 50-70 having T score less than -2.5 SD or lower at lumbar spine or proximal femur. Exclusion Criteria: Patients with renal dysfunction (serum creatinine >1.5) Primary and secondary hyperparathyroidism Secondary osteoporosis Unexplained elevated ALP (alkaline phosphatase) History of therapeutic radiation Active malignancy and patients having implant Patients who have received i.v. or oral bisphosphonates in their disease course

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Daily Teriparatide group<br>This group will recieve 20µg of teriparatide by subcutaneous route daily at 8 pm for 1 year | Drug: Teriparatide<br> <br> |
| Experimental: Weekly Teriparatide group<br>This group will recieve 60µg of teriparatide by subcutaneous route weekly at 8pm on Sunday for 1 year | Drug: Teriparatide<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoporosis, Teriparatide