Bone Marker Changes With Teriparatide/Postmenopausal Osteoporosis

Study Overview
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Brief Summary
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To test the hypothesis that Teriparatide injections given 20 micrograms/daily subcutaneously, for one month, are able to produce reliable changes in the bone marker in a severe osteoporotic population

Official Title
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Bone Marker Changes In One Month Treatment With TERIPARATIDE (LY333334) Injections (rDNA Origin) in Men and Postmenopausal Women With Severe Osteoporosis

Conditions
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Osteoporosis, Post-Menopausal

Intervention / Treatment
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* Drug: Teriparatide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presents with severe osteoporosis based on the disease diagnostic criteria and upon physician assessment Postmenopausal, nonpregnant, women older than 50 years of age, with previous fracture history such as hip, spine, wrist, ribs, clavicle, humerus, tibia, and fibula or men over 50 years of age with low impact fractures (fragility). Outpatients without concomitant diseases and with life expectancy of at least 3 years, according to the medical criteria. Cannot be on medicines that can disturb bone metabolism. Patients should be capable of self-injection, to learn the use of Pen device and are in agreement with its use. Exclusion Criteria: Directly affiliated with the conduct of this study, or are the immediate family of someone directly affiliated with the conduct of this study (that is, Lilly employees, investigators, site personnel, or their immediate families). Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. Received treatment within the last 30 days with a drug (not including study drug) that has not received regulatory approval for any indication at the time of study entry. Previously completed or withdrawn from this study or any other study investigating Teriparatide. Secondary osteoporosis or any disease that affects the bone metabolism, as renal osteodystrophy, osteomalacia, hypoparathyroidism, and hyperparathyroidism, and intestinal malabsorption. Cancer history in the 5 years prior to visit 1, with exemption of basocellular carcinoma treated and cervix carcinoma definitively treated at least 1 year before to visit 1

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

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 |
| --- | --- |
| Experimental: A<br>Teriparatide | Drug: Teriparatide<br>* Teriparatide 20 micrograms/daily subcutaneously<br>* Other names: LY333334;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To test the hypothesis that Teriparatide injections given 20 micrograms/daily subcutaneously, for one month, is able to produce reliable changes in the bone marker in a severe osteoporotic population in Puerto Rico. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To test the hypothesis that this group of patients will have a high score in the survey used by IOF as an instrument to check risk factors. |  |  | 
| Test the hypothesis that patients will have a high score in the survey used by IOF as an instrument to check risk factors. |  |  |