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

Phase 2

• Conditions: Osteoporosis; Osteopenia
• Interventions: 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

• Registration Number: NCT01604057
• Lead Sponsor: Azelon Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Status Verified: 2012-05
• Study First Submitted: 2012-05-18
• Study First Submitted QC: 2012-05-21
• Last Update Submitted: 2012-05-21
• Study First Posted: 2012-05-23
• Last Update Posted: 2012-05-23
• Primary Completion: 2012-07
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Dose Nasal Spray	ZT-034 Low Dose Nasal Spray	-
Mid Dose Nasal Spray	ZT-034 Mid Dose Nasal Spray	-
High Dose Nasal Spray	ZT-034 High Dose Nasal Spray	-
Forteo	Teriparatide	20ug subcutaneous injection daily
Placebo Nasal Spray	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in Serum P1NP from baseline to end of treatment.	6 weeks

Secondary Outcome Measures

Name	Time	Method
Change in serum calcium and incidence of hypercalcemia (pre-dose and post-dose)	baseline and 6 weeks