Study to Evaluate Effect of Intranasal Teriparatide on Serum P1NP, a Biomarker of Bone Formation, in Postmenopausal Women With Low Bone Mass

Study Overview
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Brief Summary
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This study is being conducted to evaluate the effect treatment has on serum P1NP levels, a biomarker of bone formation in postmenopausal women with low bone mass.

Official Title
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A Parallel Group Study to Evaluate the Effect of Six Weeks of Treatment With Nasal Spray (NS) ZT-034, Compared to Subcutaneous (SC) Forteo and Placebo, on Bone Formation, as Assessed by Stimulation of Serum P1NP Levels in Postmenopausal Women With Low Bone Mass

Conditions
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Osteoporosis, Osteopenia

Intervention / Treatment
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* Drug: ZT-034 Low Dose Nasal Spray
* Drug: ZT-034 Mid Dose Nasal Spray
* Drug: ZT-034 High Dose Nasal Spray
* Drug: Teriparatide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postmenopausal Females Age ≥ 45 years. Weight > 45 kg and < 90 kg Normal nasal examination at baseline. Low bone mass at lumbar spine, total hip or femoral neck (BMD T-score of ≤ - 1.5 or lower) or a recent (within 5 years of baseline) history of fragility fracture (excluding fractures of hands, feet, face and/or skull) and a T-score of -1.0 or lower at lumbar spine, total hip or femoral neck 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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Minimum Age: 45 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 |
| --- | --- |
| Experimental: Low Dose Nasal Spray<br> | Drug: ZT-034 Low Dose Nasal Spray<br>* Nasal Spray<br>|
| Experimental: Mid Dose Nasal Spray<br> | Drug: ZT-034 Mid Dose Nasal Spray<br>* Nasal Spray<br>|
| Experimental: High Dose Nasal Spray<br> | Drug: ZT-034 High Dose Nasal Spray<br>* Nasal Spray<br>|
| Active Comparator: Forteo<br>20ug subcutaneous injection daily | Drug: Teriparatide<br>* 20 mcg subcutaneous daily<br>* Other names: Forteo;|
| Placebo Comparator: Placebo Nasal Spray<br> | Drug: Placebo<br>* Nasal Spray<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Serum P1NP from baseline to end of treatment. |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum calcium and incidence of hypercalcemia (pre-dose and post-dose) |  | baseline and 6 weeks |