Study to Evaluate Effect of Intranasal Teriparatide on Bone Mineral Density in Postmenopausal Women With Low BMD

Study Overview
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Brief Summary
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This study is being conducted to compare the effect of increasing nasal teriparatide dosing on percent change in Bone Mineral Density (BMD) of the lumbar spine after 24 weeks of therapy in postmenopausal women with low bone mineral density.

Official Title
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A Phase 2, 24-Week, Multicenter, Randomized, Parallel-Group, Dose-Ranging Study To Evaluate The Effect Of Teriparatide Nasal Spray On Bone Mineral Density In Postmenopausal Women With Low Bone Mineral Density

Conditions
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Osteopenia, Osteoporosis

Intervention / Treatment
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* Drug: Teriparatide
* Drug: Teriparatide Nasal Spray
* Drug: Teriparatide Nasal Spray
* Drug: Teriparatide Nasal Spray
* Drug: Teriparatide Nasal Spray


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postmenopausal Female patients up to 89 years, inclusive; BMI ≤ 35 kg/m2, inclusive; In good health, determined by medical history and physical examination, as well as normal 12-lead ECG and vital signs; Females will be non-pregnant, non-lactating, and either post-menopausal for at least 1 year, surgically sterile (including tubal ligation, hysterectomy) for at least 3 months, until 30 days following Study Completion be willing to use an approved method of contraception; Have a minimum of two evaluable non-fractured lumbar vertebrae. Have low bone mineral density defined as having a T-score ≤ -2.0 as determined by DXA scan at either the lumbar spine (L1-L4) or total hip Exclusion Criteria: Serious Medical Condition History of diseases which affect bone metabolism other than postmenopausal osteoporosis such as Paget's disease, any secondary causes of osteoporosis, hypoparathyroidism, or hyperparathyroidism Have a history of cancer within the past 5 years, except for basal cell carcinoma Have hypocalcemia or hypercalcemia from any cause or have a recent history of kidney stones or pre-existing hypercalciuria; Have used any of the mostly commonly prescribed osteoporosis medications within 3 months of starting the investigational product, or for more than 1 month at any time within 6 months prior to starting investigational product.

Ages Eligible for Study
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Maximum Age: 89 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Teriparatide<br>* 20ug subcutaneous injection daily for 24 weeks<br>* Other names: Forteo;|
| Experimental: 2<br> | Drug: Teriparatide Nasal Spray<br>* teriparatide intranasally daily for 24 weeks<br>|
| Experimental: 3<br> | Drug: Teriparatide Nasal Spray<br>* teriparatide intranasally daily for 24 weeks<br>|
| Experimental: 4<br> | Drug: Teriparatide Nasal Spray<br>* teriparatide intranasally daily for 24 weeks<br>|
| Experimental: 5<br> | Drug: Teriparatide Nasal Spray<br>* teriparatide intranasally daily for 24 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in bone mineral density of the lumbar spine from baseline to 24 weeks post treatment. |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in bone mineral density from baseline to 12 weeks post treatment |  | 12 weeks | 
| Safety, including hypercalcemia and nasal effects |  | 24 weeks | 
| Change from baseline in bone markers PINP and CTX from baseline to 4, 12 and 24 weeks post treatment |  | 4, 12 and 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoporosis, osteopenia, bone mineral density, teriparatide