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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01604057
• Other study ID #: ZT-3201
• Status: Active, not recruiting
• Phase: Phase 2
• First received: May 18, 2012
• Last updated: May 21, 2012
• Start date: November 2011
• Est. completion date: July 2012

Study information

• Verified date: May 2012
• Source: Azelon Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteopenia
• Osteoporosis

Intervention

Drug:
• ZT-034 Low Dose Nasal Spray
Nasal Spray
• ZT-034 Mid Dose Nasal Spray
Nasal Spray
• ZT-034 High Dose Nasal Spray
Nasal Spray
• Teriparatide
20 mcg subcutaneous daily
• Placebo
Nasal Spray

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azelon Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Serum P1NP from baseline to end of treatment.		6 weeks	No
Secondary	Change in serum calcium and incidence of hypercalcemia (pre-dose and post-dose)		baseline and 6 weeks	Yes