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

Information source: Azelon Pharmaceuticals
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoporosis; Osteopenia

Intervention: ZT-034 Low Dose Nasal Spray (Drug); ZT-034 Mid Dose Nasal Spray (Drug); ZT-034 High Dose Nasal Spray (Drug); Teriparatide (Drug); Placebo (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Azelon Pharmaceuticals

Official(s) and/or principal investigator(s):
Brian MacDonald, Study Director, Affiliation: Azelon Pharmaceuticals

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.

Clinical Details

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

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

Primary outcome: Change in Serum P1NP from baseline to end of treatment.

Secondary outcome: Change in serum calcium and incidence of hypercalcemia (pre-dose and post-dose)

Eligibility

Minimum age: 45 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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

Locations and Contacts

Additional Information

Starting date: November 2011
Last updated: May 21, 2012

Page last updated: August 20, 2015

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