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

Sponsors

Lead Sponsor: Azelon Pharmaceuticals

Source Azelon Pharmaceuticals
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.

Overall Status Unknown status
Start Date 2011-11-01
Completion Date 2012-07-01
Primary Completion Date 2012-07-01
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Serum P1NP from baseline to end of treatment. 6 weeks
Secondary Outcome
Measure Time Frame
Change in serum calcium and incidence of hypercalcemia (pre-dose and post-dose) baseline and 6 weeks
Enrollment 130
Condition
Intervention

Intervention Type: Drug

Intervention Name: ZT-034 Low Dose Nasal Spray

Description: Nasal Spray

Arm Group Label: Low Dose Nasal Spray

Intervention Type: Drug

Intervention Name: ZT-034 Mid Dose Nasal Spray

Description: Nasal Spray

Arm Group Label: Mid Dose Nasal Spray

Intervention Type: Drug

Intervention Name: ZT-034 High Dose Nasal Spray

Description: Nasal Spray

Arm Group Label: High Dose Nasal Spray

Intervention Type: Drug

Intervention Name: Teriparatide

Description: 20 mcg subcutaneous daily

Arm Group Label: Forteo

Other Name: Forteo

Intervention Type: Drug

Intervention Name: Placebo

Description: Nasal Spray

Arm Group Label: Placebo Nasal Spray

Eligibility

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

Gender:

Female

Minimum Age:

45 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Brian MacDonald Study Director Azelon Pharmaceuticals
Overall Contact Contact information is only displayed when the study is recruiting subjects.
Verification Date

2012-05-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 5
Arm Group

Label: Low Dose Nasal Spray

Type: Experimental

Label: Mid Dose Nasal Spray

Type: Experimental

Label: High Dose Nasal Spray

Type: Experimental

Label: Forteo

Type: Active Comparator

Description: 20ug subcutaneous injection daily

Label: Placebo Nasal Spray

Type: Placebo Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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