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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

NCT01604057 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2012-05-23

No results posted yet for this study

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.

Conditions

Interventions

DRUG

ZT-034 Low Dose Nasal Spray

Nasal Spray

DRUG

ZT-034 Mid Dose Nasal Spray

Nasal Spray

DRUG

ZT-034 High Dose Nasal Spray

Nasal Spray

DRUG

Teriparatide

20 mcg subcutaneous daily

DRUG

Placebo

Nasal Spray

Sponsors & Collaborators

  • Azelon Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Brian MacDonald · Azelon Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-07-31
Completion
2012-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01604057 on ClinicalTrials.gov