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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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01604057
Enrollment
130
Registered
2012-05-23
Start date
2011-11-30
Completion date
2012-07-31
Last updated
2012-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteopenia, Osteoporosis

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.

Interventions

DRUGZT-034 Low Dose Nasal Spray

Nasal Spray

DRUGZT-034 Mid Dose Nasal Spray

Nasal Spray

DRUGZT-034 High Dose Nasal Spray

Nasal Spray

DRUGTeriparatide

20 mcg subcutaneous daily

DRUGPlacebo

Nasal Spray

Sponsors

Azelon Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in Serum P1NP from baseline to end of treatment.6 weeks

Secondary

MeasureTime frame
Change in serum calcium and incidence of hypercalcemia (pre-dose and post-dose)baseline and 6 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026