This trial is active, not recruiting.

Conditions osteoporosis, osteopenia
Treatments zt-034 low dose nasal spray, zt-034 mid dose nasal spray, zt-034 high dose nasal spray, teriparatide, placebo
Phase phase 2
Sponsor Azelon Pharmaceuticals
Start date November 2011
End date July 2012
Trial size 130 participants
Trial identifier NCT01604057, ZT-3201


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacodynamics study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
zt-034 low dose nasal spray
Nasal Spray
zt-034 mid dose nasal spray
Nasal Spray
zt-034 high dose nasal spray
Nasal Spray
(Active Comparator)
20ug subcutaneous injection daily
teriparatide Forteo
20 mcg subcutaneous daily
(Placebo Comparator)
Nasal Spray

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Female participants at least 45 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in May 2012.
Information provided to ClinicalTrials.gov by Azelon Pharmaceuticals.