A Study for Patients With Osteoporosis

Study Overview
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Brief Summary
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The purpose of this study is to compare the effect of injectable teriparatide to intranasal salmon calcitonin on lumbar spine bone mineral density, in the treatment of Chinese patients with established osteoporosis

Official Title
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Comparison of Teriparatide and Calcitonin in the Treatment of Men and Postmenopausal Women With Osteoporosis

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: Teriparatide
* Drug: Salmon Calcitonin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of osteoporosis No other severe disabling conditions Should have at least 1 vertebral or non-vertebral prevalent fracture, and bone mineral density T-score should be less than -2.5 Ambulatory Men (aged 40 to 85 years) or postmenopausal women (aged 55 to 85 years) Exclusion Criteria: History of a disease that affects bone metabolism History of treatment with any drug that may significantly affect bone metabolism History or presence of liver disease History or presence of kidney disease History of excessive alcohol drinking or drug abuse

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Teriparatide<br>* Subcutaneous, 20 micrograms/day, 24 weeks<br>* Other names: Forsteo;|
| Active Comparator: B<br> | Drug: Salmon Calcitonin<br>* Intranasal, 200 International Units (IU)/day, 24 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Postmenopausal Women | Lumbar spine bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline. | Baseline to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Postmenopausal Women | Total hip bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline. | Baseline to 24 weeks | 
| Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Postmenopausal Women | Measures of serum osteocalcin (nanograms per milliliter). Change = Endpoint minus baseline. | Baseline to 12 weeks and 24 weeks | 
| Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Men | Lumbar spine bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline. | Baseline to 24 weeks | 
| Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Men | Total hip bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline. | Baseline to 24 weeks | 
| Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Men | Measures of serum osteocalcin (nanograms per milliliter). Change = Endpoint minus baseline. | Baseline to 12 weeks and 24 weeks |