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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 | Clinical Trials | Clareo Health

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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

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

NCT01604057•Azelon Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

45 - No limit years

Sex

FEMALE

Healthy Volunteers

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

Key Dates

Start Date

November 1, 2011

Primary Completion Date

July 1, 2012

Completion Date

July 1, 2012

Last Updated

May 23, 2012

Enrollment

130

ACTUAL participants

Conditions

OsteoporosisOsteopenia

Interventions

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

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OsteoporosisLower Limb Fracture

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 23, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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